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

Innovent Biologics

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: IBI 360 Injection; Drug: IBI 360 Injection Sintilimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05043298

CIBI360A101

Details and patient eligibility

About

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

Full description

Phase Ia is dose escalation and dose expansion study of IBI360 monotherapy and IBI360 in combination with sintilimab in advanced or metastatic Solid Tumors; Phase Ib is an multi-cohort trial of pancreatic carcinoma, HER2 negative gastric adenocarcinoma, advanced or metastatic solid tumors to evaluate safety and preliminary efSficacy of IBI360 in combination with sintilimab and (or) chemotherapy or IBI360 monotherapy.

Enrollment: 12 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

IBI360

Experimental group

Treatment:

Drug: IBI 360 Injection

IBI 360 + Sintilimab

Experimental group

Treatment:

Drug: IBI 360 Injection Sintilimab