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

Phase 1

Completed

• Conditions: Advanced Solid Tumor
• Interventions: Drug: IBI 360 Injection; Drug: IBI 360 Injection Sintilimab

• Registration Number: NCT05043298
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

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.

Study Timeline

• Study First Submitted: 2021-09-05
• Study First Submitted QC: 2021-09-05
• Study First Posted: 2021-09-14
• Study Start: 2021-10-27
• Primary Completion: 2023-08-30
• Study Completion: 2023-08-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-14
• Last Update Posted: 2024-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IBI360	IBI 360 Injection	-
IBI 360 + Sintilimab	IBI 360 Injection Sintilimab	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerance	up to 90 days following last dose	Participant safety is characterized by frequency and severity of adverse events(according to NCI CTCAE 5.0)
Recommended Phase 2 Dose (RP2D)	up to 21 days following last dose level	A recommended phase 2 dose will be determined based on safety data including dose limiting toxicities, preliminary efficacy data, and PK data

Secondary Outcome Measures

Name	Time	Method
Efficacy	Subjects were randomized 6 months and 1 year later	Tumor response will be determined by the revised Response Evaluation Criteria in Solid Tumors version 1.1 (RECISTv1.1).
Pharmacokinetics	Up to 48 weeks following first dose	Terminal Half Life（T1/2）
Immunogenicity	up to 90 days following last dose	Incidence of anti-drug antibodies (ADA) will be measured

Trial Locations

Locations (1)

Innovent Biologics (suzhou) Co. , Ltd.; 🇨🇳 Suzhou, Jiangsu, China