IN10018 Monotherapy or in Combination With Docetaxel in Gastric or GEJ Adenocarcinoma

• Status: Active, not recruiting
• Trial end date: 2022-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: InxMed (Shanghai) Co., Ltd.
• Treatments: Docetaxel

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.