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IMP4297 in Combination With Temozolomide in Patients With Advanced Solid Tumors and Small Cell Lung Cancer

Primary Purpose

Advanced Solid Tumours, Small Cell Lung Cancer

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
IMP4297(senaparib)
Sponsored by
Impact Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Solid Tumours

Eligibility Criteria

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

Inclusion Criteria:

  1. The patient must voluntarily participate in this clinical study and be willing and able to provide written informed consent/assent for the trial.
  2. Age ≥ 18 years old on the day of signing informed consent form (ICF), males or females
  3. Patient population:

    1. In Part I: The patient must have histologically or cytologically confirmed advanced solid tumor that is refractory to standard treatment or for which no standard treatment exists, including but not limited to triple-negative breast cancer (TNBC), SCLC, ovarian cancer (OC) and metastatic castration-resistant prostate cancer (mCRPC).
    2. In Part II: The patients must be histologically or cytologically confirmed ES-SCLC with disease progression after one and only one course of 1L standard platinum-based therapy. Anti-PD-1 or anti-PD-L1 antibody therapy is acceptable as long as it's part of the 1L treatment. Including platinum sensitive and platinum resistant patients. Platinum sensitive is defined as the relapse-free interval exceeds 90 days after treatment with platinum doublets is completed; The platinum resistant represents disease relapses within 90 days of treatment completion during a chemotherapy-free interval (CFI).
    3. In Part I: Patients have an ECOG performance status of 0 to 1.
    4. In Part II: Patients have an ECOG performance status of 0 to 2.
    5. Patients have a life expectancy of ≥12 weeks.
    6. In Part II: patients have at least 1 measurable lesion per RECIST v1.1, including a previously irradiated lesion if has progressed since radiotherapy, that can be accurately measured at baseline which is suitable for accurate repeated measurements
  4. Patients have adequate organ function, as indicated by the following laboratory values (had not received blood transfusion, apheresis infusion, erythropoietin, granulocyte colony-stimulating factor, and other relevant medical support within 28 days before the administration of the IPs
  5. Female patients should meet at least 1 of the following criteria before they can participate in the study:

    • Females who have no childbearing potential (i.e., physiologically incapable of pregnancy), including those who have undergone hysterectomy, bilateral oophorectomy, or bilateral salpingectomy.
    • Post-menopausal (total cessation of menses for ≥1 year).
    • For those with childbearing potential, they should have a negative serum pregnancy test during the screening period (within 7 days prior to the first dose of the IPs), should not be in lactation, and willing to take effective contraceptive measures throughout the study period, from study entry up to 6 months after the last dose of the IP(s).
  6. Male patients are eligible to participate in the study if they have undergone vasectomy or agree to use effective methods of contraception from study entry up to 6 months after the last dose of the IP(s).

Exclusion Criteria:

  1. Patients with primary tumor in central nervous system (CNS) and active or untreated central CNS metastases and/or carcinomatous meningitis should be excluded. Patients with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks and, have no evidence of new or enlarging brain metastases and no requirements for corticosteroids 14 days prior to dosing with IPs.
  2. Patients with serious acute and chronic infections, including:

    • Patients with an uncontrolled acute infection, or an active infection requiring systemic treatment, or patients who have received systemic antibiotics within 2 weeks prior to the first dose of the IPs; prophylaxis use of systemic antibiotics treatment for upper tract infection is allowed as long as no violation with the requirement in Section 6.5 Concomitant Therapy.
    • Patients who have a known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome or positive HIV testing should undergo CD4+ T-cell test during the screening period. Patients with CD4+ T-cell counts < 350 cells/uL are ineligible for enrollment. Patients with unknown HIV infection status who are unwilling to undergo HIV testing should not be enrolled in the study;
    • Patients who have known active hepatitis B or C. To be included in the study, patients with hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) antibody positive test results during screening must be further tested for hepatitis B virus (HBV) DNA titer (excluding patients with a DNA titer of more than 2500 copies [cps]/mL or 500 IU/mL) and HCV RNA (excluding patients with an HCV RNA concentration exceeding the lower detection limit of the assay) to exclude active hepatitis B or hepatitis C infection requiring treatment. Hepatitis B virus carriers, patients with stable hepatitis B infection after drug treatment (DNA titer not exceeding 2500 copies [cps]/mL or 500 IU/mL) and hepatitis C infected patients who received treatment and achieved sustained virologic response for at least 12 weeks can be enrolled.
    • Note: If the lower detection limit of the HBV DNA assay in the study centers is higher than 2500 copies [cps]/mL or 500 IU/mL, the patients in the study center with an HBV DNA assay result lower than the lower detection limit of the assay can be enrolled.
    • Active tuberculosis
  3. Patients who have previously received PARP inhibitors.
  4. Patients who have received strong CYP3A4 inhibitors or inducers prior to the first dose of the IPs (the patient can be enrolled if the elution period prior to the first dose of the IPs is ≥5 half-lives), or patients who need to continue receiving these medications during the study period.
  5. Patients who have received a live-virus vaccination within 28 days of the planned start of study.
  6. Patients who have participated a study of an investigational agent and received study therapy or used an investigational device within 28 days of the first dose of treatment.
  7. Patients have not recovered (i.e., to ≤Grade 1 or to baseline, as evaluated by NCI-CTCAE v5.0) from cytotoxic therapy-induced AEs, except for alopecia.
  8. Patients who have received anti-cancer chemotherapy, endocrine therapy, herbal/alternative therapies (including Chinese herbal or Chinese medicine or proprietary Chinese medicine), or other anti-cancer systemic treatment (except anti-cancer antibody) within 5 half-lives or 14 days, whichever is longer prior to the first dose of the IPs. Patients who have received anti-cancer antibody within 28 days prior to the first dose of the IPs.
  9. Patients who have undergone a major surgery within 28 days prior to the study treatment, or have undergone a radical radiotherapy, or have undergone a palliative radiotherapy within 14 days prior to the study treatment, or have used a radioactive drug (Strontium, Samarium, etc.) within 56 days prior to the study treatment.
  10. In Part II of the study, patients who have other malignancies within 2 years prior to the first dose of the IPs will be excluded. except for radically treated locally curable malignant tumors, such as basal or squamous cell skin cancer, superficial bladder cancer, or prostate, cervical or breast carcinoma in situ.
  11. Patients with uncontrolled pleural effusion, pericardial effusion or ascites requiring recurrent drainage procedures (once monthly or more frequently). Please contact medical monitor if any further discussion or clarification is needed.
  12. Patients with a history of seizures.
  13. Patients with a previously documented diagnosis of myelodysplastic syndrome (MDS).
  14. Patients who have major cardiovascular diseases (such as congestive heart failure, unstable angina, atrial fibrillation, arrhythmia); patients who have acute myocardial infarction, unstable angina, stroke, or transient ischemic attack within 6 months prior to the first dose of the IPs; patients who have congestive heart failure (≥New York Heart Association [NYHA] Classification Class II); patients who have severe arrhythmia requiring medication (including QT interval [QTc] prolongation corrected by the Fridericia's formula [QTcF] of more than 480 msec, pacemaker installation, and previous diagnosis of congenital long QT syndrome).
  15. Patients who are unable to swallow capsules. Patients have gastrointestinal illnesses that may affect the absorption of oral medication IMP4297 and temozolomide.
  16. Patients with a known hypersensitivity to IMP4297, temozolomide or any of the excipients of the products.
  17. Patients who have received transplantation including patients with previous allogeneic bone marrow transplant.
  18. Patients known to have a history of alcoholism or drug abuse.
  19. The investigator believes that the patient's underlying disease may put the patient at risk in IP administration or may affect the evaluation of toxicity events or AEs.

Sites / Locations

  • GenHarp Clinical Solutions
  • Gabrail Cancer Researh Center
  • Mark H. Zangmeister Center
  • Sarah Cannon Research Institute - Tennessee OncologyRecruiting
  • Border Medical OncologyRecruiting
  • Blacktown HospitalRecruiting
  • Orange HospitalRecruiting
  • Peninsula Health Frankston Hospital
  • Beijing Cancer HospitalRecruiting
  • Jilin Cancer HospitalRecruiting
  • Fudan University Shanghai Cancer Center
  • Hubei Cancer HospitalRecruiting
  • Chungbuk National University HospitalRecruiting
  • The Catholic university of Korea, st. Vincent's HospitalRecruiting
  • Yonsei university health system, Severance HospitalRecruiting
  • Asan Medical CenterRecruiting
  • China Medical University HospitalRecruiting
  • National Cheng Kung University HospitalRecruiting
  • Chi Mei Medical CenterRecruiting
  • National Taiwan University HospitalRecruiting
  • Chang Gung Medical Foundation LinkoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IMP4297(senaparib) and temozolomide

Arm Description

IMP4297 and temozolomide

Outcomes

Primary Outcome Measures

Part I: Dose Escalation safety and tolerability
TEAEs, vital signs, physical examinations, electrocardiogram (ECG), laboratory tests (including serum chemistry, hematology, and urinalysis, coagulation), etc.
Part I: Dose Escalation MTD
the maximum tolerated dose:the highest dose level at which <1/3 patients experience DLT
Part I: Dose Escalation RP2D
the recommended phase 2 dose
Part II: Dose Expansion Overall Response Rate (ORR)
the percentage of patients who had a best response rating of CR and PR which was maintained ≥4 weeks from the first manifestation of that rating.

Secondary Outcome Measures

Part I: Dose Escalation plasma PK profile of IMP4297 and temozolomide
To characterize the plasma PK profile of IMP4297 and temozolomide via population PK (popPK) modeling
Part I: Dose Escalation anti-tumor activity
Progression-free survival (PFS),Duration of response (DoR),Disease control rate (DCR)
Part I: Dose Escalation,effect of IMP4297 on QT interval
Correlation between IMP4297 plasma concentration and QT interval
Part II: Dose Expansion safety and tolerability
TEAE, vital signs, physical examinations, ECG, laboratory tests (including serum chemistry, hematology, urinalysis and coagulation), etc.
Part II: Dose Expansion anti-tumor activity
progression-free survival (PFS ),duration of response (DoR),Disease control rate (DCR),overall survival (OS)
Part II: Dose Expansion PK profile of IMP4297 and temozolomide
PK parameters derived from IMP4297 and temozolomide plasma concentration data
Part II: Dose Expansion effect of IMP4297 on QT interval
Correlation between IMP4297 plasma concentration and QT interval

Full Information

First Posted
June 14, 2020
Last Updated
September 28, 2023
Sponsor
Impact Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04434482
Brief Title
IMP4297 in Combination With Temozolomide in Patients With Advanced Solid Tumors and Small Cell Lung Cancer
Official Title
A Phase Ib/II, Open-Label, Multi-Center, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of IMP4297 in Combination With Temozolomide in Patients With Advanced Solid Tumors and Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 7, 2020 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Impact Therapeutics, 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
This is an open-label, multi-center, dose-escalation and dose-expansion phase I study to evaluate the safety, tolerability, PK characteristics and anti-tumor activity of PARP inhibitor IMP4297 and temozolomide combination therapy in patients with advanced solid tumors and with ES-SCLC who develops disease progression after 1L platinum-based regimen.
Detailed Description
This study will be conducted in two parts. Part I of the study will be dose escalation evaluation to determine the MTD and/or recommended phase 2 dose(RP2D) of IMP4297 in combination with temozolomide. Part II of the study will be conducted in two expansion cohorts (sensitive ES-SCLC cohort and resistant ES-SCLC cohort) to further evaluate the anti-tumor activity, safety and tolerability of this regimen in ES-SCLC patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Solid Tumours, Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
113 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IMP4297(senaparib) and temozolomide
Arm Type
Experimental
Arm Description
IMP4297 and temozolomide
Intervention Type
Drug
Intervention Name(s)
IMP4297(senaparib)
Other Intervention Name(s)
temozolomide
Intervention Description
The dose levels will be escalated following a modified 3+3 dose escalation scheme.
Primary Outcome Measure Information:
Title
Part I: Dose Escalation safety and tolerability
Description
TEAEs, vital signs, physical examinations, electrocardiogram (ECG), laboratory tests (including serum chemistry, hematology, and urinalysis, coagulation), etc.
Time Frame
From signing ICF until safety follow-up
Title
Part I: Dose Escalation MTD
Description
the maximum tolerated dose:the highest dose level at which <1/3 patients experience DLT
Time Frame
from the initiation of study drugs until the end of dose escalation phase(approximately 1 year)
Title
Part I: Dose Escalation RP2D
Description
the recommended phase 2 dose
Time Frame
from the initiation of study drugs until the end of dose escalation phase(approximately 1 year)
Title
Part II: Dose Expansion Overall Response Rate (ORR)
Description
the percentage of patients who had a best response rating of CR and PR which was maintained ≥4 weeks from the first manifestation of that rating.
Time Frame
from the initiation of study drugs until documented disease progression, withdrawal of consent, loss to follow-up, death, initiation of new anti-cancer treatment or termination of study, which occurs first.
Secondary Outcome Measure Information:
Title
Part I: Dose Escalation plasma PK profile of IMP4297 and temozolomide
Description
To characterize the plasma PK profile of IMP4297 and temozolomide via population PK (popPK) modeling
Time Frame
Cycle 1 Day 1, Cycle 1 Day 15,Cycle 2 Day 1,Any cycle after cycle 2,unscheduled visit
Title
Part I: Dose Escalation anti-tumor activity
Description
Progression-free survival (PFS),Duration of response (DoR),Disease control rate (DCR)
Time Frame
from the initiation of study drugs until documented disease progression, withdrawal of consent, loss to follow-up, death, initiation of new anti-cancer treatment or termination of study
Title
Part I: Dose Escalation,effect of IMP4297 on QT interval
Description
Correlation between IMP4297 plasma concentration and QT interval
Time Frame
Cycle 1 Day 1,Cycle 1 Day 15,Cycle 2 Day 1,CnD1,EOT, unscheduled visit
Title
Part II: Dose Expansion safety and tolerability
Description
TEAE, vital signs, physical examinations, ECG, laboratory tests (including serum chemistry, hematology, urinalysis and coagulation), etc.
Time Frame
From signing ICF until safety follow-up
Title
Part II: Dose Expansion anti-tumor activity
Description
progression-free survival (PFS ),duration of response (DoR),Disease control rate (DCR),overall survival (OS)
Time Frame
from the initiation of study drugs until documented disease progression, withdrawal of consent, loss to follow-up, death, initiation of new anti-cancer treatment or termination of study
Title
Part II: Dose Expansion PK profile of IMP4297 and temozolomide
Description
PK parameters derived from IMP4297 and temozolomide plasma concentration data
Time Frame
Cycle 1 Day 1,Cycle 1 Day 15,Cycle 2 Day 1,Any cycle after cycle 2,unscheduled visit
Title
Part II: Dose Expansion effect of IMP4297 on QT interval
Description
Correlation between IMP4297 plasma concentration and QT interval
Time Frame
Cycle 1 Day 1,Cycle 1 Day 15,Cycle 2 Day 1,CnD1,EOT, unscheduled visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patient must voluntarily participate in this clinical study and be willing and able to provide written informed consent/assent for the trial. Age ≥ 18 years old on the day of signing informed consent form (ICF), males or females Patient population: In Part I: The patient must have histologically or cytologically confirmed advanced solid tumor that is refractory to standard treatment or for which no standard treatment exists, including but not limited to triple-negative breast cancer (TNBC), SCLC, ovarian cancer (OC) and metastatic castration-resistant prostate cancer (mCRPC). In Part II: The patients must be histologically or cytologically confirmed ES-SCLC with disease progression after one and only one course of 1L standard platinum-based therapy. Anti-PD-1 or anti-PD-L1 antibody therapy is acceptable as long as it's part of the 1L treatment. Including platinum sensitive and platinum resistant patients. Platinum sensitive is defined as the relapse-free interval exceeds 90 days after treatment with platinum doublets is completed; The platinum resistant represents disease relapses within 90 days of treatment completion during a chemotherapy-free interval (CFI). In Part I: Patients have an ECOG performance status of 0 to 1. In Part II: Patients have an ECOG performance status of 0 to 2. Patients have a life expectancy of ≥12 weeks. In Part II: patients have at least 1 measurable lesion per RECIST v1.1, including a previously irradiated lesion if has progressed since radiotherapy, that can be accurately measured at baseline which is suitable for accurate repeated measurements Patients have adequate organ function, as indicated by the following laboratory values (had not received blood transfusion, apheresis infusion, erythropoietin, granulocyte colony-stimulating factor, and other relevant medical support within 28 days before the administration of the IPs Female patients should meet at least 1 of the following criteria before they can participate in the study: Females who have no childbearing potential (i.e., physiologically incapable of pregnancy), including those who have undergone hysterectomy, bilateral oophorectomy, or bilateral salpingectomy. Post-menopausal (total cessation of menses for ≥1 year). For those with childbearing potential, they should have a negative serum pregnancy test during the screening period (within 7 days prior to the first dose of the IPs), should not be in lactation, and willing to take effective contraceptive measures throughout the study period, from study entry up to 6 months after the last dose of the IP(s). Male patients are eligible to participate in the study if they have undergone vasectomy or agree to use effective methods of contraception from study entry up to 6 months after the last dose of the IP(s). Exclusion Criteria: Patients with primary tumor in central nervous system (CNS) and active or untreated central CNS metastases and/or carcinomatous meningitis should be excluded. Patients with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks and, have no evidence of new or enlarging brain metastases and no requirements for corticosteroids 14 days prior to dosing with IPs. Patients with serious acute and chronic infections, including: Patients with an uncontrolled acute infection, or an active infection requiring systemic treatment, or patients who have received systemic antibiotics within 2 weeks prior to the first dose of the IPs; prophylaxis use of systemic antibiotics treatment for upper tract infection is allowed as long as no violation with the requirement in Section 6.5 Concomitant Therapy. Patients who have a known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome or positive HIV testing should undergo CD4+ T-cell test during the screening period. Patients with CD4+ T-cell counts < 350 cells/uL are ineligible for enrollment. Patients with unknown HIV infection status who are unwilling to undergo HIV testing should not be enrolled in the study; Patients who have known active hepatitis B or C. To be included in the study, patients with hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) antibody positive test results during screening must be further tested for hepatitis B virus (HBV) DNA titer (excluding patients with a DNA titer of more than 2500 copies [cps]/mL or 500 IU/mL) and HCV RNA (excluding patients with an HCV RNA concentration exceeding the lower detection limit of the assay) to exclude active hepatitis B or hepatitis C infection requiring treatment. Hepatitis B virus carriers, patients with stable hepatitis B infection after drug treatment (DNA titer not exceeding 2500 copies [cps]/mL or 500 IU/mL) and hepatitis C infected patients who received treatment and achieved sustained virologic response for at least 12 weeks can be enrolled. Note: If the lower detection limit of the HBV DNA assay in the study centers is higher than 2500 copies [cps]/mL or 500 IU/mL, the patients in the study center with an HBV DNA assay result lower than the lower detection limit of the assay can be enrolled. Active tuberculosis Patients who have previously received PARP inhibitors. Patients who have received strong CYP3A4 inhibitors or inducers prior to the first dose of the IPs (the patient can be enrolled if the elution period prior to the first dose of the IPs is ≥5 half-lives), or patients who need to continue receiving these medications during the study period. Patients who have received a live-virus vaccination within 28 days of the planned start of study. Patients who have participated a study of an investigational agent and received study therapy or used an investigational device within 28 days of the first dose of treatment. Patients have not recovered (i.e., to ≤Grade 1 or to baseline, as evaluated by NCI-CTCAE v5.0) from cytotoxic therapy-induced AEs, except for alopecia. Patients who have received anti-cancer chemotherapy, endocrine therapy, herbal/alternative therapies (including Chinese herbal or Chinese medicine or proprietary Chinese medicine), or other anti-cancer systemic treatment (except anti-cancer antibody) within 5 half-lives or 14 days, whichever is longer prior to the first dose of the IPs. Patients who have received anti-cancer antibody within 28 days prior to the first dose of the IPs. Patients who have undergone a major surgery within 28 days prior to the study treatment, or have undergone a radical radiotherapy, or have undergone a palliative radiotherapy within 14 days prior to the study treatment, or have used a radioactive drug (Strontium, Samarium, etc.) within 56 days prior to the study treatment. In Part II of the study, patients who have other malignancies within 2 years prior to the first dose of the IPs will be excluded. except for radically treated locally curable malignant tumors, such as basal or squamous cell skin cancer, superficial bladder cancer, or prostate, cervical or breast carcinoma in situ. Patients with uncontrolled pleural effusion, pericardial effusion or ascites requiring recurrent drainage procedures (once monthly or more frequently). Please contact medical monitor if any further discussion or clarification is needed. Patients with a history of seizures. Patients with a previously documented diagnosis of myelodysplastic syndrome (MDS). Patients who have major cardiovascular diseases (such as congestive heart failure, unstable angina, atrial fibrillation, arrhythmia); patients who have acute myocardial infarction, unstable angina, stroke, or transient ischemic attack within 6 months prior to the first dose of the IPs; patients who have congestive heart failure (≥New York Heart Association [NYHA] Classification Class II); patients who have severe arrhythmia requiring medication (including QT interval [QTc] prolongation corrected by the Fridericia's formula [QTcF] of more than 480 msec, pacemaker installation, and previous diagnosis of congenital long QT syndrome). Patients who are unable to swallow capsules. Patients have gastrointestinal illnesses that may affect the absorption of oral medication IMP4297 and temozolomide. Patients with a known hypersensitivity to IMP4297, temozolomide or any of the excipients of the products. Patients who have received transplantation including patients with previous allogeneic bone marrow transplant. Patients known to have a history of alcoholism or drug abuse. The investigator believes that the patient's underlying disease may put the patient at risk in IP administration or may affect the evaluation of toxicity events or AEs.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Song
Phone
021 68411121
Email
min.song@impacttherapeutics.com
Facility Information:
Facility Name
GenHarp Clinical Solutions
City
Evergreen Park
State/Province
Illinois
ZIP/Postal Code
60805
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asia Beamon
Facility Name
Gabrail Cancer Researh Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirstie Armstrong
Facility Name
Mark H. Zangmeister Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43219
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy Zangmeister
Facility Name
Sarah Cannon Research Institute - Tennessee Oncology
City
Tennessee
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brittany Callaway
Facility Name
Border Medical Oncology
City
Albury
State/Province
New South Wales
ZIP/Postal Code
2640
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Debbie Metcalf
Facility Name
Blacktown Hospital
City
Blacktown
State/Province
New South Wales
ZIP/Postal Code
2148
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Murray
Facility Name
Orange Hospital
City
Orange
State/Province
New South Wales
ZIP/Postal Code
2800
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carol Han
Facility Name
Peninsula Health Frankston Hospital
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Raineri
Facility Name
Beijing Cancer Hospital
City
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoling Chen
Facility Name
Jilin Cancer Hospital
City
Jilin
ZIP/Postal Code
130000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Cheng
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Wang
Facility Name
Hubei Cancer Hospital
City
Wuhan
ZIP/Postal Code
430079
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Zhang
Facility Name
Chungbuk National University Hospital
City
Cheongju-si
ZIP/Postal Code
2864
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
So Yun Yun
Facility Name
The Catholic university of Korea, st. Vincent's Hospital
City
Gyeonggi-do
ZIP/Postal Code
16247
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jung Soon Kim
Facility Name
Yonsei university health system, Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee Seul Gi
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kang Yoonsook
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pei-Chen Hsu
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsiang-Lien Li
Facility Name
Chi Mei Medical Center
City
Tainan
ZIP/Postal Code
73657
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lillian Lee
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shu-Ling Chang
Facility Name
Chang Gung Medical Foundation Linko
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsiao-Ying Yang

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

IMP4297 in Combination With Temozolomide in Patients With Advanced Solid Tumors and Small Cell Lung Cancer

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