Back to resultsIN10018 Monotherapy or in Combination With Docetaxel in Gastric or GEJ Adenocarcinoma
Primary Purpose
Gastric Cancer
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
IN10018
Docetaxel
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer
Eligibility Criteria
Inclusion Criteria:
1.Has histologically or cytologically confirmed diagnosis of locally advanced and/or metastatic gastric or GEJ adenocarcinoma.
- For monotherapy, participants need to be failed to respond to standard therapy or standard or curative therapy does not exist or is not tolerable.
- For combination therapy, participants need to have disease progression within 3 months after at least first-line therapy.
- 2.Has at least one measurable tumor lesion per RECIST 1.1.
- 3.Has an ECOG performance status of 0 or 1.
- 4.Estimated life expectancy is more than 3 months.
- 5.Adequate organ and bone marrow functions.
- 6.Has been fully informed and provided written informed consent for the study
Exclusion Criteria:
- 1.Has other histological types other than adenocarcinoma.
2.For participants with HER2/neu positive tumors or have an unknown tumor status, need to match the following:
- If HER2/neu positive, participant must have documentation of disease progression on trastuzumab or other anti-HER2/neu therapy.
- Participants with unknown status must have their HER2/neu status determined locally. If HER2/neu-negative, the participant will be eligible. If HER2/neu-positive, the participant must have documentation of disease progression on trastuzumab or other anti-HER2/neu therapy.
- 3.Has had disease progression after docetaxel/paclitaxel containing treatment (combination therapy only).
- 4.Has received prior systemic therapies (i.e. chemotherapy, biotherapy, endocrinotherapy, and immunotherapy) within 4 weeks prior to start of study treatment.
- 5.Has received prior radiotherapy within 2 weeks prior to start of study treatment.
- 6.Has severe allergy or hypersensitivity to IN10018 and/or docetaxel, or any components used in their preparation or has contraindication for taxane therapy. For participants in monotherapy group, only restriction to IN10018 applies.
- 7.Has severe renal disease or impaired renal function.
- 8.Has an active infection requiring systemic therapy within 2 weeks prior to start of study treatment.
- 9.Has a history or current evidence of interstitial lung disease.
Sites / Locations
- Anyang Tumor Hospital
- Henan Cancer Hospital
- The First Affiliated Hospital of Zhengzhou University
- The Affiliated Hospital of Nanjing University Medical School
- The First Hospital of China Medical University
- Shanghai East Hospital
- The First Affiliated Hospital of XI 'AN Jiaotong University
- Tianjin Medical University Cancer Institute & Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
IN10018 Monotherapy
IN10018 Combination with Docetaxel
Arm Description
Participants will be instructed to take IN10018 orally once daily at approximately the same time each day, to ensure a dose interval of approximately 24 hours.
Participants will be instructed to take IN10018 orally once daily at approximately the same time each day, to ensure a dose interval of approximately 24 hours. Docetaxel 75mg/m2 every 21 days a cycle.
Outcomes
Primary Outcome Measures
Safety and tolerability in combination group
Number of patients with adverse event in combination group; Number of patients with laboratory abnormalities, abnormal vital signs and abnormal 12-lead ECG in combination group
DLTs in combination group
Number of patients with dose-limited toxicities (DLTs) in combination group
Phase II dose of IN10018 in combination with Docetaxel
Determine the recommended phase II dose (RP2D) of IN10018 in combination with Docetaxel
Secondary Outcome Measures
Safety and tolerability in IN10018 monotherapy group
Number of patients with adverse event in monotherapy group; Number of patients with laboratory abnormalities, abnormal vital signs and abnormal 12-lead ECG in monotherapy group
DLTs in IN10018 monotherapy group
Number of patients with dose-limited toxicities (DLTs) in monotherapy group
Objective response rate (ORR) per RECIST v1.1
Defined as the proportion of patients with complete response (CR) or partial response (PR).
Duration of objective response (DOR) per RECIST v1.1.
Defined as the time from start of the first documentation of CR or PR to the first documentation of disease progression or to death due to any cause, whichever comes first
Disease Control Rate (DCR) per RECIST v1.1.
Defined as the proportion of patients with CR, PR, or stable disease (SD)
Progression-free survival (PFS) per RECIST v1.1.
Defined as the time from start of study treatment to first documentation of disease progression or to death due to any cause, whichever comes first.
Overall survival (OS).
Defined as the time from the start of any study treatment to the date of death due to any cause.
Pharmacokinetics (PK):AUC
Area under the concentration-time curve (AUC).
Pharmacokinetics (PK):Cmax
PK: Maximum concentration (Cmax).
PK:Tmax
Time to Cmax (Tmax).
PK:Ctrough
Trough concentration (Ctrough).
PK:t1/2
Elimination half-life (t1/2).
PK:CL/F
apparent clearance (CL/F).
PK:Vd/F
Apparent volume of distribution (Vd/F).
Full Information
NCT ID
NCT05327231
First Posted
March 29, 2022
Last Updated
November 15, 2022
Sponsor
InxMed (Shanghai) Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05327231
Brief Title
IN10018 Monotherapy or in Combination With Docetaxel in Gastric or GEJ Adenocarcinoma
Official Title
A Phase I, Open-label Clinical Trial to Evaluate Safety, Tolerability, Antitumor Activities and Pharmacokinetics of IN10018 as Mono or Combination Therapy in Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
July 9, 2020 (Actual)
Primary Completion Date
December 3, 2021 (Actual)
Study Completion Date
March 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InxMed (Shanghai) Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
This is a phase I, multi-center clinical trial to evaluate the safety, tolerability, antitumor activities and pharmacokinetics of IN10018 as monotherapy or in combination with docetaxel in previously-treated locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Detailed Description
Eligibility patients will be enrolled into the study and assigned to treatment groups: 1) IN10018 monotherapy group, and 2) IN10018+Docetaxel combination group. This study contains 2 parts of dose escalation and dose expansion for each treatment group. The monotherapy group will enroll patients failed to respond to standard therapy or standard or curative therapy does not exist or is not tolerable, and explore IN10018 monotherapy RP2D with the starting dose of IN10018 100mg QD per 3+3 design. The combination group will enroll patients who have disease progression within 3 months after at least first-line therapy, and explore IN10018+docetaxel RP2D with the starting dose of IN10018 100mg QD + docetaxel 75mg/m2 per 3+3 design. The dose expansion part will start after attaining the RP2D of IN10018 monotherapy and IN10018+docetaxel combination therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IN10018 Monotherapy
Arm Type
Experimental
Arm Description
Participants will be instructed to take IN10018 orally once daily at approximately the same time each day, to ensure a dose interval of approximately 24 hours.
Arm Title
IN10018 Combination with Docetaxel
Arm Type
Experimental
Arm Description
Participants will be instructed to take IN10018 orally once daily at approximately the same time each day, to ensure a dose interval of approximately 24 hours. Docetaxel 75mg/m2 every 21 days a cycle.
Intervention Type
Drug
Intervention Name(s)
IN10018
Intervention Description
IN10018 orally once daily at approximately the same time each day, to ensure a dose interval of approximately 24 hours.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
Docetaxel 75mg/m2 every 21 days a cycle.
Primary Outcome Measure Information:
Title
Safety and tolerability in combination group
Description
Number of patients with adverse event in combination group; Number of patients with laboratory abnormalities, abnormal vital signs and abnormal 12-lead ECG in combination group
Time Frame
up to 24 months
Title
DLTs in combination group
Description
Number of patients with dose-limited toxicities (DLTs) in combination group
Time Frame
21 days
Title
Phase II dose of IN10018 in combination with Docetaxel
Description
Determine the recommended phase II dose (RP2D) of IN10018 in combination with Docetaxel
Time Frame
up to 24 months
Secondary Outcome Measure Information:
Title
Safety and tolerability in IN10018 monotherapy group
Description
Number of patients with adverse event in monotherapy group; Number of patients with laboratory abnormalities, abnormal vital signs and abnormal 12-lead ECG in monotherapy group
Time Frame
up to 24 months
Title
DLTs in IN10018 monotherapy group
Description
Number of patients with dose-limited toxicities (DLTs) in monotherapy group
Time Frame
up to 24 months
Title
Objective response rate (ORR) per RECIST v1.1
Description
Defined as the proportion of patients with complete response (CR) or partial response (PR).
Time Frame
up to 24 months
Title
Duration of objective response (DOR) per RECIST v1.1.
Description
Defined as the time from start of the first documentation of CR or PR to the first documentation of disease progression or to death due to any cause, whichever comes first
Time Frame
up to 24 months
Title
Disease Control Rate (DCR) per RECIST v1.1.
Description
Defined as the proportion of patients with CR, PR, or stable disease (SD)
Time Frame
up to 24 months
Title
Progression-free survival (PFS) per RECIST v1.1.
Description
Defined as the time from start of study treatment to first documentation of disease progression or to death due to any cause, whichever comes first.
Time Frame
up to 24 months
Title
Overall survival (OS).
Description
Defined as the time from the start of any study treatment to the date of death due to any cause.
Time Frame
up to 30 months
Title
Pharmacokinetics (PK):AUC
Description
Area under the concentration-time curve (AUC).
Time Frame
up to 24 months
Title
Pharmacokinetics (PK):Cmax
Description
PK: Maximum concentration (Cmax).
Time Frame
up to 24 months
Title
PK:Tmax
Description
Time to Cmax (Tmax).
Time Frame
up to 24 months
Title
PK:Ctrough
Description
Trough concentration (Ctrough).
Time Frame
up to 24 months
Title
PK:t1/2
Description
Elimination half-life (t1/2).
Time Frame
up to 24 months
Title
PK:CL/F
Description
apparent clearance (CL/F).
Time Frame
up to 24 months
Title
PK:Vd/F
Description
Apparent volume of distribution (Vd/F).
Time Frame
up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1.Has histologically or cytologically confirmed diagnosis of locally advanced and/or metastatic gastric or GEJ adenocarcinoma.
For monotherapy, participants need to be failed to respond to standard therapy or standard or curative therapy does not exist or is not tolerable.
For combination therapy, participants need to have disease progression within 3 months after at least first-line therapy.
2.Has at least one measurable tumor lesion per RECIST 1.1.
3.Has an ECOG performance status of 0 or 1.
4.Estimated life expectancy is more than 3 months.
5.Adequate organ and bone marrow functions.
6.Has been fully informed and provided written informed consent for the study
Exclusion Criteria:
1.Has other histological types other than adenocarcinoma.
2.For participants with HER2/neu positive tumors or have an unknown tumor status, need to match the following:
If HER2/neu positive, participant must have documentation of disease progression on trastuzumab or other anti-HER2/neu therapy.
Participants with unknown status must have their HER2/neu status determined locally. If HER2/neu-negative, the participant will be eligible. If HER2/neu-positive, the participant must have documentation of disease progression on trastuzumab or other anti-HER2/neu therapy.
3.Has had disease progression after docetaxel/paclitaxel containing treatment (combination therapy only).
4.Has received prior systemic therapies (i.e. chemotherapy, biotherapy, endocrinotherapy, and immunotherapy) within 4 weeks prior to start of study treatment.
5.Has received prior radiotherapy within 2 weeks prior to start of study treatment.
6.Has severe allergy or hypersensitivity to IN10018 and/or docetaxel, or any components used in their preparation or has contraindication for taxane therapy. For participants in monotherapy group, only restriction to IN10018 applies.
7.Has severe renal disease or impaired renal function.
8.Has an active infection requiring systemic therapy within 2 weeks prior to start of study treatment.
9.Has a history or current evidence of interstitial lung disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Li, Doctor
Organizational Affiliation
Shanghai East Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anyang Tumor Hospital
City
Anyang
State/Province
Henan
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
The Affiliated Hospital of Nanjing University Medical School
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
The First Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
Shanghai East Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
The First Affiliated Hospital of XI 'AN Jiaotong University
City
Xi'an
State/Province
Shanxi
Country
China
Facility Name
Tianjin Medical University Cancer Institute & Hospital
City
Tianjin
State/Province
Tianjin
Country
China
12. IPD Sharing Statement
Learn more about this trial
IN10018 Monotherapy or in Combination With Docetaxel in Gastric or GEJ Adenocarcinoma
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