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A Study of TRK-950 in Combinations With Anti-Cancer Treatment Regimens in Patients With Advanced Solid Tumors

Primary Purpose

Solid Tumor, Colorectal Cancer, Cholangiocarcinoma

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
TRK-950
Irinotecan
Leucovorin
5-FU
Gemcitabine
Cisplatin
Carboplatin
Ramucirumab
Paclitaxel
Nivolumab
Pembrolizumab
Imiquimod Cream
Bevacizumab
Topotecan
PLD
Sponsored by
Toray Industries, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solid Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically confirmed solid malignancy for which the following treatment regimens are warranted:
  • Arm A. Colorectal Cancer with no prior history of treatment with Irinotecan alone or in combination: FOLFIRI as standard of care
  • Arm B. Cholangiocarcinoma, Bladder Cancer with no prior history of treatment with Gemcitabine alone or in combination: Gemcitabine / Cisplatin as standard of care
  • Arm C and Expansion Cohort 1. Ovarian Cancer who have relapsed at least 6 or more months after completion of a previous platinum-based therapy and have no prior history of treatment with gemcitabine alone or in combination: Gemcitabine / Carboplatin as standard of care
  • Arm D and Expansion Cohort 2. Gastric Cancer including Gastroesophageal Junction with no prior history of treatment with Ramucirumab, Paclitaxel or any Taxane class drug: Ramucirumab / Paclitaxel as standard of care
  • Arm E. Solid Tumors: Eligible for PD1 Inhibitor (Nivolumab or Pembrolizumab) monotherapy as standard of care according to the approved drug label by the relevant regulatory authority
  • Arm F. Locally advanced or metastatic disease in a cancer with at least one palpable subcutaneous malignant lesion (≤ 2 cm in diameter) for treatment with TRK-950 and Imiquimod cream (US Sites Only)
  • Arm G. Renal Cell Carcinoma with no prior history of treatment with Bevacizumab alone or in combination: Bevacizumab for use in a fourth line or later treatment
  • Arm H. Melanoma patients who progressed while taking Nivolumab, Pembrolizumab, or Ipilimumab, within the last 6 months prior to cycle 1 day 1
  • Arm J. Colorectal Cancer patients who progressed on FOLFIRI or any other Irinotecan-containing therapy regimen within the last 6 months prior to cycle 1 day 1
  • Arm K. (US Sites Only). Platinum Sensitive epithelial ovarian, primary peritoneal or fallopian tube cancer with ≤ 2 prior treatment lines who have recurred > 6 months after most recent platinum-based chemotherapy and who are eligible for gemcitabine, carboplatin, and Bevacizumab as standard of care for dosing of TRK-950(Lower-dose)
  • Arms M and O. Platinum Resistant epithelial ovarian, primary peritoneal or fallopian tube cancer with ≤ 5 prior treatment regimens, as defined below and who are eligible for topotecan or pegylated liposomal doxorubicin as standard of care for dosing of TRK-950(Lower-dose)

    • Patients who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum, must have had a response, and then progressed between 3 months and less than or equal to 6 months after the last date of platinum.
    • Patients who have received 2 to 5 lines of prior therapy must have received at least 4 cycles of platinum and then progressed within 6 months after the date of the last dose of platinum.
    • Prior treatment with bevacizumab is required for patients with 1 to 2 prior lines of therapy
  • Arm Q. Gastric Cancer including GEJ cancer with only 1 prior treatment regimen, which recurred during or within 4 months after frontline treatment, and no prior history of treatment with Ramucirumab, Paclitaxel or any Taxane class drug for metastatic disease: eligible to receive Ramucirumab/Paclitaxel as standard of care (Lower-dose)
  • Arm R. Clear cell renal cell carcinoma with no prior history of treatment with Bevacizumab alone or in combination: Bevacizumab for use in a fourth line or later treatment. (Lower-dose)
  • Primary or metastatic tumors measurable per RECIST v1.1 on CT scan or by calipers (subcutaneous lesions)
  • Karnofsky performance of ≥70
  • Life expectancy of at least 3 months
  • Age ≥ 18 years
  • Signed, written IRB-approved informed consent

Exclusion Criteria:

  • Laboratory values or medications that are contraindicated in the selected standard of care treatment regimens
  • New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG
  • Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy. Prophylactic antibiotics are acceptable.
  • Pregnant or nursing women
  • Treatment with radiation therapy within 2 weeks, or treatment with surgery, chemotherapy, immunotherapy, targeted therapy or investigational therapy within four weeks prior to initiation of study treatment (6 weeks for nitrosoureas or mitomycin C, and 2 weeks or 5 half-lives whichever is longer for TKIs).
  • Unwillingness or inability to comply with procedures required in this protocol
  • Known active infection with HIV, hepatitis B, hepatitis C
  • Serious nonmalignant disease that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
  • Patients who are currently receiving any other investigational agent
  • Any contraindicated condition or drug which would make the patient ineligible for the respective treatment regimen that is to be used in combination with TRK-950 (for example, autoimmune disorders for nivolumab or pembrolizumab treatment) as described in the Full Prescribing Information

Sites / Locations

  • HonorHealth Research InstituteRecruiting
  • AOA-HOPERecruiting
  • USC Norris Comprehensive Cancer CenterRecruiting
  • HOAG Memorial Hospital PresbyterianRecruiting
  • Ochsner Clinic FoundationRecruiting
  • Atlantic Health SystemRecruiting
  • Perlmutter Cancer Center at NYU LangoneRecruiting
  • Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute and Research Center)Recruiting
  • Northwest Cancer SpecialistsRecruiting
  • Texas Oncology, P.A. Baylor Charles A. Sammons Cancer CenterRecruiting
  • Texas Oncology - Downtown Fort Worth Cancer CenterRecruiting
  • Virginia Cancer Specialists, PCRecruiting
  • Medical College of WisconsinRecruiting
  • Centre Léon BérardRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Arm A: TRK-950 + FOLFIRI

Arm B: TRK-950 + Gemcitabine/Cisplatin

Arm C: TRK-950 + Gemcitabine/Carboplatin

Arm D: TRK-950 + Ramucirumab/Paclitaxel

Arm E: TRK-950 + PD1 inhibitors

Arm F: TRK-950 + Imiquimod Cream

Arm G: TRK-950 + Bevacizumab

Arm H: TRK-950 + PD1 inhibitors

Arm J: TRK-950 + FOLFIRI

Arm K: TRK-950(Lower-dose) + Gemcitabine / Carboplatin / Bevacizumab

Arm M: TRK-950(Lower-dose) + Topotecan

Arm O: TRK-950(Lower-dose) + PLD

Arm Q: TRK-950(Lower-dose) +Ramucirumab/Paclitaxel

Arm R: TRK-950(Lower-dose) +Bevacizumab

Arm Description

Colorectal Cancer TRK-950 will be administered intravenously (IV) on days 1, 8, 15, and 22 of a 28-day cycle. On days 1 and 15 Irinotecan will be administered IV. Leucovorin will be infused to match the duration of the irinotecan infusion. 5-FU will be administered as IV bolus, followed by TRK-950 administration. After the TRK-950, 5-FU will be administered by a continuous infusion.

Cholangiocarcinoma or Bladder Cancer TRK-950 will be administered IV on days 1, 8 and 15 of a 21-day cycle. After the administration of TRK-950 on days 1 and 8, Cisplatin will be administered by infusion. Then, Gemcitabine will be administered as an IV infusion.

Ovarian Cancer TRK-950 will be administered IV on days 1, 8 and 15 of a 21-day cycle. After the administration of TRK-950 on days 1 and 8, Gemcitabine will be administered as an intravenous infusion. On day 1, following the administration of TRK-950 and Gemcitabine, Carboplatin will be administered IV.

Gastric Cancer TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. After the administration of TRK-950 on days 1 and 15, Ramucirumab will be administered as an IV infusion. Paclitaxel will be dosed on days 1, 8 and 15, after the Ramucirumab on days 1 and 15 and after the TRK-950 on day 8.

•Solid Tumors E-1: TRK-950 + Nivolumab •TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. After the administration of TRK-950 on days 1 and 15, Nivolumab will be administered as an IV infusion. E-2: TRK-950 + Pembrolizumab •TRK-950 will be administered IV on days 1, 8 and 15 of a 21-day cycle. After the administration of TRK-950 on day 1, Pembrolizumab will be administered as an IV infusion.

Palpable subcutaneous malignant lesions TRK-950 will be administered IV on days 1, 8 and 15 of a 21-day cycle. Imiquimod cream is to be applied 5 of 7 days in a row with 2 days rest for a maximum of 2 cycles (total 6 weeks).

Renal Cell Carcinoma TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. After the administration of TRK-950 on days 1 and 15, Bevacizumab will be administered as an IV infusion.

•Melanoma H-1: TRK-950 + Nivolumab •TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. After the administration of TRK-950 on days 1 and 15, Nivolumab will be administered as an IV infusion. H-2: TRK-950 + Pembrolizumab •TRK-950 will be administered IV on days 1, 8 and 15 of a 21-day cycle. After the administration of TRK-950 on day 1, Pembrolizumab will be administered as an IV infusion.

Colorectal Cancer TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. On days 1 and 15 Irinotecan will be administered IV. Leucovorin will be infused to match the duration of the irinotecan infusion. 5-FU will be administered as IV bolus, followed by TRK-950 administration. After the TRK-950, 5-FU will be administered by a continuous infusion.

Platinum Sensitive epithelial ovarian, primary peritoneal or fallopian tube cancer TRK-950 will be administered IV on days 1, 8 and 15 of a 21-day cycle. On all dosing days, TRK-950 will be administered IV after the relevant combination regimen is dosed. Gemcitabine will be administered as an intravenous infusion on days 1 and 8. On day 1, following the administration of Gemcitabine, Carboplatin will be administered as an intravenous infusion. Also on Day 1 of each cycle, Bevacizumab will be administered IV next. After 6 cycles of chemotherapy the patient will be transitioned to maintenance treatment. On Day 1 of each maintenance cycle, Bevacizumab will be administered IV. Maintenance treatment will be continued as long as there is no evidence of progressive disease.

Platinum Resistant epithelial ovarian, primary peritoneal or fallopian tube cancer TRK-950 will be administered IV on days 1, 8, 15 and 22 of a 28-day cycle. Topotecan will be administered as an intravenous infusion on days 1, 8, 15 of a 28-day cycle. On days 1, 8 and 15, TRK-950 will be administered IV after the topotecan infusion.

Platinum Resistant epithelial ovarian, primary peritoneal or fallopian tube cancer TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. PLD will be dosed as IV on Day 1 of each cycle. On days that TRK-950 and PLD are both dosed, PLD will be dosed first.

Gastric cancer TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. On all dosing days, TRK-950 will be administered IV after the relevant combination regimen is dosed. On days 1 and 15, ramucirumab will be administered IV. Paclitaxel will be dosed on days 1, 8 and 15, after ramucirumab on days 1 and 15, before TRK-950 on day 8.

Renal cell carcinoma cancer TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. Bevacizumab will be dosed as IV on Day 1 and 15 of each cycle. On days that TRK-950 and Bevacizumab are both dosed, Bevacizumab will be dosed first.

Outcomes

Primary Outcome Measures

Frequency of patients experiencing treatment emergent adverse events as assessed by CTCAE v5.0
Frequency of patients experiencing adverse events of special interest (AESIs)
Blood pressure
mmHg
Heart rate
bpm
Respiratory rate
bpm
Temperature
°F or °C
Weight
lbs/kg
Height
inches/cm
Performance status using Karnofsky performance status criteria
QTc interval determined from 12-lead Electrocardiogram
msec
QRS interval determined from 12-lead Electrocardiogram
msec
Frequency of patients with laboratory abnormalities (Complete Blood Count, Coagulation, Urinalysis and Serum Chemistry)

Secondary Outcome Measures

Overall response rate (ORR)
Disease Control Rate (DCR)
Serum concentration of TRK-950
Plasma concentration of Gemcitabine for the first six patients in Arm K
Plasma concentration of Carboplatin for the first six patients in Arm K
Serum concentration of Bevacizumab for the first six patients in Arm K
Plasma concentration of Topotecan for the first six patients in Arm M
Plasma concentration of PLD for the first six patients in Arm O
Serum concentration of Ramucirumab for the first six patients in Arm Q
Plasma concentration of Paclitaxel for the first six patients in Arm Q
Serum concentration of Bevacizumab for the first six patients in Arm R

Full Information

First Posted
March 7, 2019
Last Updated
October 2, 2022
Sponsor
Toray Industries, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT03872947
Brief Title
A Study of TRK-950 in Combinations With Anti-Cancer Treatment Regimens in Patients With Advanced Solid Tumors
Official Title
A Phase 1b, Multicenter Study to Determine the Dose, Safety, Efficacy and Pharmacokinetics of TRK-950 When Used in Combinations With Selected Anti-Cancer Treatment Regimens in Patients With Selected Advanced Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2019 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Toray Industries, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The main purpose of this study is to establish the safety and the recommended dose of TRK-950 in combination with FOLFIRI, Gemcitabine / Cisplatin, Gemcitabine / Carboplatin, Ramucirumab / Paclitaxel, PD1 inhibitors (Nivolumab or Pembrolizumab), and Imiquimod Cream, Bevacizumab, Gemcitabine / Carboplatin / Bevacizumab, Topotecan, and Pegylated liposomal doxorubicin (PLD) for selected advanced solid tumors.
Detailed Description
This study is an open-label, Phase 1b study evaluating TRK-950 in combination with 1) FOLFIRI or 2) Gemcitabine / Cisplatin or 3) Gemcitabine / Carboplatin or 4) Ramucirumab/Paclitaxel or 5) PD1 inhibitors (Nivolumab or Pembrolizumab) or 6) Imiquimod Cream for subcutaneous lesions 7) Bevacizumab 8) Gemcitabine / Carboplatin / Bevacizumab, 9) Topotecan, or 10) PLD in Patients with Selected Advanced Solid Tumors. The objectives of this study are to determine the safety, tolerability, MTD, recommended Phase 2 dose (RP2D), PK, and preliminary anti-tumor activity of TRK-950 when used in combination with other treatment regimens.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumor, Colorectal Cancer, Cholangiocarcinoma, Bladder Cancer, Ovarian Cancer, Gastric Cancer, Palpable Subcutaneous Malignant Lesions, Renal Cell Carcinoma, Melanoma, Epithelial Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
169 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A: TRK-950 + FOLFIRI
Arm Type
Experimental
Arm Description
Colorectal Cancer TRK-950 will be administered intravenously (IV) on days 1, 8, 15, and 22 of a 28-day cycle. On days 1 and 15 Irinotecan will be administered IV. Leucovorin will be infused to match the duration of the irinotecan infusion. 5-FU will be administered as IV bolus, followed by TRK-950 administration. After the TRK-950, 5-FU will be administered by a continuous infusion.
Arm Title
Arm B: TRK-950 + Gemcitabine/Cisplatin
Arm Type
Experimental
Arm Description
Cholangiocarcinoma or Bladder Cancer TRK-950 will be administered IV on days 1, 8 and 15 of a 21-day cycle. After the administration of TRK-950 on days 1 and 8, Cisplatin will be administered by infusion. Then, Gemcitabine will be administered as an IV infusion.
Arm Title
Arm C: TRK-950 + Gemcitabine/Carboplatin
Arm Type
Experimental
Arm Description
Ovarian Cancer TRK-950 will be administered IV on days 1, 8 and 15 of a 21-day cycle. After the administration of TRK-950 on days 1 and 8, Gemcitabine will be administered as an intravenous infusion. On day 1, following the administration of TRK-950 and Gemcitabine, Carboplatin will be administered IV.
Arm Title
Arm D: TRK-950 + Ramucirumab/Paclitaxel
Arm Type
Experimental
Arm Description
Gastric Cancer TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. After the administration of TRK-950 on days 1 and 15, Ramucirumab will be administered as an IV infusion. Paclitaxel will be dosed on days 1, 8 and 15, after the Ramucirumab on days 1 and 15 and after the TRK-950 on day 8.
Arm Title
Arm E: TRK-950 + PD1 inhibitors
Arm Type
Experimental
Arm Description
•Solid Tumors E-1: TRK-950 + Nivolumab •TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. After the administration of TRK-950 on days 1 and 15, Nivolumab will be administered as an IV infusion. E-2: TRK-950 + Pembrolizumab •TRK-950 will be administered IV on days 1, 8 and 15 of a 21-day cycle. After the administration of TRK-950 on day 1, Pembrolizumab will be administered as an IV infusion.
Arm Title
Arm F: TRK-950 + Imiquimod Cream
Arm Type
Experimental
Arm Description
Palpable subcutaneous malignant lesions TRK-950 will be administered IV on days 1, 8 and 15 of a 21-day cycle. Imiquimod cream is to be applied 5 of 7 days in a row with 2 days rest for a maximum of 2 cycles (total 6 weeks).
Arm Title
Arm G: TRK-950 + Bevacizumab
Arm Type
Experimental
Arm Description
Renal Cell Carcinoma TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. After the administration of TRK-950 on days 1 and 15, Bevacizumab will be administered as an IV infusion.
Arm Title
Arm H: TRK-950 + PD1 inhibitors
Arm Type
Experimental
Arm Description
•Melanoma H-1: TRK-950 + Nivolumab •TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. After the administration of TRK-950 on days 1 and 15, Nivolumab will be administered as an IV infusion. H-2: TRK-950 + Pembrolizumab •TRK-950 will be administered IV on days 1, 8 and 15 of a 21-day cycle. After the administration of TRK-950 on day 1, Pembrolizumab will be administered as an IV infusion.
Arm Title
Arm J: TRK-950 + FOLFIRI
Arm Type
Experimental
Arm Description
Colorectal Cancer TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. On days 1 and 15 Irinotecan will be administered IV. Leucovorin will be infused to match the duration of the irinotecan infusion. 5-FU will be administered as IV bolus, followed by TRK-950 administration. After the TRK-950, 5-FU will be administered by a continuous infusion.
Arm Title
Arm K: TRK-950(Lower-dose) + Gemcitabine / Carboplatin / Bevacizumab
Arm Type
Experimental
Arm Description
Platinum Sensitive epithelial ovarian, primary peritoneal or fallopian tube cancer TRK-950 will be administered IV on days 1, 8 and 15 of a 21-day cycle. On all dosing days, TRK-950 will be administered IV after the relevant combination regimen is dosed. Gemcitabine will be administered as an intravenous infusion on days 1 and 8. On day 1, following the administration of Gemcitabine, Carboplatin will be administered as an intravenous infusion. Also on Day 1 of each cycle, Bevacizumab will be administered IV next. After 6 cycles of chemotherapy the patient will be transitioned to maintenance treatment. On Day 1 of each maintenance cycle, Bevacizumab will be administered IV. Maintenance treatment will be continued as long as there is no evidence of progressive disease.
Arm Title
Arm M: TRK-950(Lower-dose) + Topotecan
Arm Type
Experimental
Arm Description
Platinum Resistant epithelial ovarian, primary peritoneal or fallopian tube cancer TRK-950 will be administered IV on days 1, 8, 15 and 22 of a 28-day cycle. Topotecan will be administered as an intravenous infusion on days 1, 8, 15 of a 28-day cycle. On days 1, 8 and 15, TRK-950 will be administered IV after the topotecan infusion.
Arm Title
Arm O: TRK-950(Lower-dose) + PLD
Arm Type
Experimental
Arm Description
Platinum Resistant epithelial ovarian, primary peritoneal or fallopian tube cancer TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. PLD will be dosed as IV on Day 1 of each cycle. On days that TRK-950 and PLD are both dosed, PLD will be dosed first.
Arm Title
Arm Q: TRK-950(Lower-dose) +Ramucirumab/Paclitaxel
Arm Type
Experimental
Arm Description
Gastric cancer TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. On all dosing days, TRK-950 will be administered IV after the relevant combination regimen is dosed. On days 1 and 15, ramucirumab will be administered IV. Paclitaxel will be dosed on days 1, 8 and 15, after ramucirumab on days 1 and 15, before TRK-950 on day 8.
Arm Title
Arm R: TRK-950(Lower-dose) +Bevacizumab
Arm Type
Experimental
Arm Description
Renal cell carcinoma cancer TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. Bevacizumab will be dosed as IV on Day 1 and 15 of each cycle. On days that TRK-950 and Bevacizumab are both dosed, Bevacizumab will be dosed first.
Intervention Type
Biological
Intervention Name(s)
TRK-950
Intervention Description
Intravenously over 60 minutes
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
Intravenously over 30 - 90 minutes
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Intervention Description
Intravenously over 30 - 90 minutes
Intervention Type
Drug
Intervention Name(s)
5-FU
Intervention Description
Intravenously bolus and intravenously for two days
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Intravenously over 30 minutes
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Intravenously over 60 minutes
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Intravenously per package insert
Intervention Type
Biological
Intervention Name(s)
Ramucirumab
Intervention Description
Intravenously over 60 minutes
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Intravenously
Intervention Type
Biological
Intervention Name(s)
Nivolumab
Intervention Description
Intravenously over 30 minutes
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Intervention Description
Intravenously over 30 minutes
Intervention Type
Drug
Intervention Name(s)
Imiquimod Cream
Intervention Description
Topically
Intervention Type
Biological
Intervention Name(s)
Bevacizumab
Intervention Description
Intravenously over 90 minutes for the first dose, over 60 for the second dose and over 30 minutes for all subsequent doses
Intervention Type
Drug
Intervention Name(s)
Topotecan
Intervention Description
Intravenously over 30 minutes
Intervention Type
Drug
Intervention Name(s)
PLD
Intervention Description
Intravenously over 60 minutes
Primary Outcome Measure Information:
Title
Frequency of patients experiencing treatment emergent adverse events as assessed by CTCAE v5.0
Time Frame
through study completion, an average of 1 year
Title
Frequency of patients experiencing adverse events of special interest (AESIs)
Time Frame
through study completion, an average of 1 year
Title
Blood pressure
Description
mmHg
Time Frame
through study completion, an average of 1 year
Title
Heart rate
Description
bpm
Time Frame
through study completion, an average of 1 year
Title
Respiratory rate
Description
bpm
Time Frame
through study completion, an average of 1 year
Title
Temperature
Description
°F or °C
Time Frame
through study completion, an average of 1 year
Title
Weight
Description
lbs/kg
Time Frame
through study completion, an average of 1 year
Title
Height
Description
inches/cm
Time Frame
through study completion, an average of 1 year
Title
Performance status using Karnofsky performance status criteria
Time Frame
through study completion, an average of 1 year
Title
QTc interval determined from 12-lead Electrocardiogram
Description
msec
Time Frame
through study completion, an average of 1 year
Title
QRS interval determined from 12-lead Electrocardiogram
Description
msec
Time Frame
through study completion, an average of 1 year
Title
Frequency of patients with laboratory abnormalities (Complete Blood Count, Coagulation, Urinalysis and Serum Chemistry)
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Overall response rate (ORR)
Time Frame
through study completion, an average of 1 year
Title
Disease Control Rate (DCR)
Time Frame
through study completion, an average of 1 year
Title
Serum concentration of TRK-950
Time Frame
through study completion, an average of 1 year
Title
Plasma concentration of Gemcitabine for the first six patients in Arm K
Time Frame
At the beginning of Cycle 1 and Cycle 4 (each cycle is 21 days)
Title
Plasma concentration of Carboplatin for the first six patients in Arm K
Time Frame
At the beginning of Cycle 1 and Cycle 4 (each cycle is 21 days)
Title
Serum concentration of Bevacizumab for the first six patients in Arm K
Time Frame
At the beginning of Cycle 1, Cycle 2, Cycle 4 and Cycle 5 (each cycle is 21 days)
Title
Plasma concentration of Topotecan for the first six patients in Arm M
Time Frame
At the beginning of Cycle 1 and Cycle 3 (each cycle is 28 days)
Title
Plasma concentration of PLD for the first six patients in Arm O
Time Frame
At the beginning and middle of Cycle 1 and Cycle 3 (each cycle is 28 days)
Title
Serum concentration of Ramucirumab for the first six patients in Arm Q
Time Frame
At the beginning and middle of Cycle 1 and Cycle 4 (each cycle is 28 days)
Title
Plasma concentration of Paclitaxel for the first six patients in Arm Q
Time Frame
At the beginning of Cycle 1 and Cycle 4 (each cycle is 28 days)
Title
Serum concentration of Bevacizumab for the first six patients in Arm R
Time Frame
At the beginning and middle of Cycle 1 and Cycle 4 (each cycle is 28 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed solid malignancy for which the following treatment regimens are warranted: Arm A. Colorectal Cancer with no prior history of treatment with Irinotecan alone or in combination: FOLFIRI as standard of care Arm B. Cholangiocarcinoma, Bladder Cancer with no prior history of treatment with Gemcitabine alone or in combination: Gemcitabine / Cisplatin as standard of care Arm C and Expansion Cohort 1. Ovarian Cancer who have relapsed at least 6 or more months after completion of a previous platinum-based therapy and have no prior history of treatment with gemcitabine alone or in combination: Gemcitabine / Carboplatin as standard of care Arm D and Expansion Cohort 2. Gastric Cancer including Gastroesophageal Junction with no prior history of treatment with Ramucirumab, Paclitaxel or any Taxane class drug: Ramucirumab / Paclitaxel as standard of care Arm E. Solid Tumors: Eligible for PD1 Inhibitor (Nivolumab or Pembrolizumab) monotherapy as standard of care according to the approved drug label by the relevant regulatory authority Arm F. Locally advanced or metastatic disease in a cancer with at least one palpable subcutaneous malignant lesion (≤ 2 cm in diameter) for treatment with TRK-950 and Imiquimod cream (US Sites Only) Arm G. Renal Cell Carcinoma with no prior history of treatment with Bevacizumab alone or in combination: Bevacizumab for use in a fourth line or later treatment Arm H. Melanoma patients who progressed while taking Nivolumab, Pembrolizumab, or Ipilimumab, within the last 6 months prior to cycle 1 day 1 Arm J. Colorectal Cancer patients who progressed on FOLFIRI or any other Irinotecan-containing therapy regimen within the last 6 months prior to cycle 1 day 1 Arm K. (US Sites Only). Platinum Sensitive epithelial ovarian, primary peritoneal or fallopian tube cancer with ≤ 2 prior treatment lines who have recurred > 6 months after most recent platinum-based chemotherapy and who are eligible for gemcitabine, carboplatin, and Bevacizumab as standard of care for dosing of TRK-950(Lower-dose) Arms M and O. Platinum Resistant epithelial ovarian, primary peritoneal or fallopian tube cancer with ≤ 5 prior treatment regimens, as defined below and who are eligible for topotecan or pegylated liposomal doxorubicin as standard of care for dosing of TRK-950(Lower-dose) Patients who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum, must have had a response, and then progressed between 3 months and less than or equal to 6 months after the last date of platinum. Patients who have received 2 to 5 lines of prior therapy must have received at least 4 cycles of platinum and then progressed within 6 months after the date of the last dose of platinum. Prior treatment with bevacizumab is required for patients with 1 to 2 prior lines of therapy Arm Q. Gastric Cancer including GEJ cancer with only 1 prior treatment regimen, which recurred during or within 4 months after frontline treatment, and no prior history of treatment with Ramucirumab, Paclitaxel or any Taxane class drug for metastatic disease: eligible to receive Ramucirumab/Paclitaxel as standard of care (Lower-dose) Arm R. Clear cell renal cell carcinoma with no prior history of treatment with Bevacizumab alone or in combination: Bevacizumab for use in a fourth line or later treatment. (Lower-dose) Primary or metastatic tumors measurable per RECIST v1.1 on CT scan or by calipers (subcutaneous lesions) Karnofsky performance of ≥70 Life expectancy of at least 3 months Age ≥ 18 years Signed, written IRB-approved informed consent Exclusion Criteria: Laboratory values or medications that are contraindicated in the selected standard of care treatment regimens New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy. Prophylactic antibiotics are acceptable. Pregnant or nursing women Treatment with radiation therapy within 2 weeks, or treatment with surgery, chemotherapy, immunotherapy, targeted therapy or investigational therapy within four weeks prior to initiation of study treatment (6 weeks for nitrosoureas or mitomycin C, and 2 weeks or 5 half-lives whichever is longer for TKIs). Unwillingness or inability to comply with procedures required in this protocol Known active infection with HIV, hepatitis B, hepatitis C Serious nonmalignant disease that could compromise protocol objectives in the opinion of the investigator and/or the sponsor Patients who are currently receiving any other investigational agent Any contraindicated condition or drug which would make the patient ineligible for the respective treatment regimen that is to be used in combination with TRK-950 (for example, autoimmune disorders for nivolumab or pembrolizumab treatment) as described in the Full Prescribing Information
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vicki Bauernschub, BSN, RN
Phone
602 358 8324
Email
vbauernschub@td2inc.com
Facility Information:
Facility Name
HonorHealth Research Institute
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joyce Schaffer, MSN,RN,AOCNS
Phone
480-323-1339
Facility Name
AOA-HOPE
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
AOA-HOPE
Phone
520-886-0206
First Name & Middle Initial & Last Name & Degree
Julie Klinker, BSN
Phone
(520)269-3821
Email
Julie.klinker@usoncology.com
Facility Name
USC Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiomara Menendez, BSN, RN
Phone
323-409-4368
Email
Xiomara.Menendez@med.usc.edu
Facility Name
HOAG Memorial Hospital Presbyterian
City
Newport
State/Province
California
ZIP/Postal Code
92663
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chi Nguyen, CCRP
Phone
949-764-6763
Email
chi.nguyen@hoag.org
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Woolery, RN
Email
Amanda.woolery@ochsner.org
Facility Name
Atlantic Health System
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Alistar, Dr.
Phone
973-971-7960
Email
Angela.Alistar@atlantichealth.org
Facility Name
Perlmutter Cancer Center at NYU Langone
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Priyanka Patel, BS
Email
Priyanka.Patel@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Brianne Boljonis, BSN,RN
Email
Brianne.Boljonis@nyulangone.org
Facility Name
Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute and Research Center)
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oncology Associates of Oregon, P.C.
Phone
541-683-5001
First Name & Middle Initial & Last Name & Degree
Jeanne Schaffer, RN-BSN
Email
Jeanne.Schaffer@usoncology.com
Facility Name
Northwest Cancer Specialists
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Northwest Cancer Specialists
Phone
503-528-5005
First Name & Middle Initial & Last Name & Degree
Amber Holden, BA
Phone
(360)597-1300
Email
amber.holden@compassoncology.com
Facility Name
Texas Oncology, P.A. Baylor Charles A. Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Texas Oncology, P.A.
Phone
214-370-1000
First Name & Middle Initial & Last Name & Degree
Rita Lopez, AS
Phone
(214)584-3236
Email
rita.lopez2@usoncology.com
Facility Name
Texas Oncology - Downtown Fort Worth Cancer Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nori Sullivan, RN, BSN, CCRC
Phone
817-413-1760
Email
nori.sullivan@usoncology.com
Facility Name
Virginia Cancer Specialists, PC
City
Leesburg
State/Province
Virginia
ZIP/Postal Code
20176
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Virginia Cancer Specialists, PC
Phone
703-554-6800
First Name & Middle Initial & Last Name & Degree
Carrie Friedman, Research Nurse Navigator
Phone
(703)636-1473
Email
carrie.friedman@usoncology.com
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Medical College of Wisconsin
Phone
866-680-0505
Ext
8900
Email
cccto@mcw.edu
First Name & Middle Initial & Last Name & Degree
Medical College of Wisconsin
Phone
414-805-8900
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69373
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Cassier, M.D.
Phone
+33 (0)4 26 55 68 33

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study of TRK-950 in Combinations With Anti-Cancer Treatment Regimens in Patients With Advanced Solid Tumors

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