Status:
COMPLETED
IN10018 Monotherapy or in Combination With Docetaxel in Gastric or GEJ Adenocarcinoma
Lead Sponsor:
InxMed (Shanghai) Co., Ltd.
Conditions:
Gastric Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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-...
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 esc...
Eligibility Criteria
Inclusion
- 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.
- Has at least one measurable tumor lesion per RECIST 1.1.
- Has an ECOG performance status of 0 or 1.
- Estimated life expectancy is more than 3 months.
- Adequate organ and bone marrow functions.
- Has been fully informed and provided written informed consent for the study
Exclusion
- Has other histological types other than adenocarcinoma.
- 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.
- Has had disease progression after docetaxel/paclitaxel containing treatment (combination therapy only).
- Has received prior systemic therapies (i.e. chemotherapy, biotherapy, endocrinotherapy, and immunotherapy) within 4 weeks prior to start of study treatment.
- Has received prior radiotherapy within 2 weeks prior to start of study treatment.
- 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.
- Has severe renal disease or impaired renal function.
- Has an active infection requiring systemic therapy within 2 weeks prior to start of study treatment.
- Has a history or current evidence of interstitial lung disease.
Key Trial Info
Start Date :
July 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2022
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT05327231
Start Date
July 9 2020
End Date
March 31 2022
Last Update
November 16 2022
Active Locations (8)
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1
Anyang Tumor Hospital
Anyang, Henan, China
2
Henan Cancer Hospital
Zhengzhou, Henan, China
3
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
4
The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China