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

Study Overview
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Brief Summary
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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
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Phase Ia/Ib dose escalation and dose expansion study of IBI360 monotherapy in advanced or metastatic Solid Tumors.

Official Title
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A Phase Ia/Ib Open-Label, Multi-Center Clinical Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of IBI360 Monotherapy or in Combination With Sintilimab and (or) Chemotherapy in Advanced or Metastatic Solid Tumors

Conditions
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Advanced Solid Tumor

Intervention / Treatment
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* Drug: IBI 360 Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide signed informed consent; Male or female aged at 18-75 (inclusive) years; Expected survival ≥12 weeks; ECOG PS score 0 or 1; Provide archival or fresh tissues for CLDN18.2 expression analysis; Adequate laboratory parameters; 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: The subjects who received the treatment with CLDN18.2 monoclonal antibody or CLDN-18.2 CART; The subjects who received other anti-tumor medication within 4 weeks prior to the initial dose of the study drug; 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; The subjects with history of hypersensitivity to the study drug; The subjects were not recovery after surgery with history of gastrointestinal perforation or fistula within 6 months prior to the enrollment; The subjects with symptomatic central nervous system (CNS) metastasis or carcinomatous meningitis; The subjects with pyloric obstruction; The subjects with active or poorly controlled serious infections

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IBI360<br> | Drug: IBI 360 Injection<br>* IBI 360 dose level of escalation IV Q3W Day 1<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response | Tumor response will be determined by the revised Response Evaluation Criteria in Solid Tumors version 1.1 (RECISTv1.1). | Subjects were randomized 6 months and 1 year later | 
| Area under plasma concentration vs time curve(AUC) |  | Up to 48 weeks following first dose | 
| Peak plasma concentration(Cmax) |  | Up to 48 weeks following first dose | 
| Terminal Half Life（T1/2） |  | Up to 48 weeks following first dose | 
| Immunogenicity | Incidence of anti-drug antibodies (ADA) will be measured | up to 90 days following last dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced Solid Tumor