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

NCT ID: NCT05043298

Last Updated: 2024-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-27
• Study Completion Date: 2023-08-30

Brief Summary

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

Detailed 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.

Conditions

Advanced Solid Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IBI360

Group Type: EXPERIMENTAL

IBI 360 Injection

Intervention Type: DRUG

IBI 360 dose level of escalation IV Q3W Day 1

IBI 360 + Sintilimab

Group Type: EXPERIMENTAL

IBI 360 Injection Sintilimab

Intervention Type: DRUG

IBI 360 dose level of escalation IV Q3W Day 1 Sintilimab 200mg IV Q3W Day 1

Interventions

IBI 360 Injection

IBI 360 dose level of escalation IV Q3W Day 1

Intervention Type: DRUG

IBI 360 Injection Sintilimab

IBI 360 dose level of escalation IV Q3W Day 1 Sintilimab 200mg IV Q3W Day 1

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Innovent Biologics (suzhou) Co. , Ltd.

Suzhou, Jiangsu, China

Countries

China

Other Identifiers

CIBI360A101

Identifier Type: -

Identifier Source: org_study_id