A Phase Ia/Ib Clinical Trial of IBI360 Monotherapy or in Combination With Sintilimab and (or) Chemotherapy in Advanced or Metastatic Solid Tumors

• Status: Not yet recruiting
• Trial end date: 2024-06-18
• Target enrollment: 0
• Participant gender: All

Summary

This is an open label Phase Ia trial to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of IBI360 monotherapy in Advanced or Metastatic Solid Tumors

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

Details

• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Criteria

Inclusion Criteria:

1. Provide signed informed consent;

2. Male or female aged at 18-75 (inclusive) years;

3. Expected survival ≥12 weeks;

4. ECOG PS score 0 or 1;

5. Provide archival or fresh tissues for CLDN18.2 expression analysis;

6. Adequate laboratory parameters;

7. Suffer from advanced or metastatic malignant local solid tumors confirmed by histological diagnosis and meet the criteria of the enrolled group as follows:

Ia: The subjects for whom no standard treatment regimens are available or who is intolerable to standard treatments.

Ib: pancreatic carcinoma, HER2 negative gastric adenocarcinoma, advanced or metastatic solid tumors

Exclusion Criteria:

1. The subjects who received the treatment with CLDN18.2 monoclonal antibody or CLDN-18.2 CART;

2. The subjects who received other anti-tumor medication within 4 weeks prior to the initial dose of the study drug;

3. Any toxicity due to previous anti-tumor therapy that has not yet resolved to NCI CTCAE v5.0 grade 0 or 1 prior to the first dose of study treatment;

4. The subjects with history of hypersensitivity to the study drug;

5. The subjects were not recovery after surgery with history of gastrointestinal perforation or fistula within 6 months prior to the enrollment;

6. The subjects with symptomatic central nervous system (CNS) metastasis or carcinomatous meningitis;

7. The subjects with pyloric obstruction;

8. The subjects with active or poorly controlled serious infections