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

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

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

Study Overview

• Status: Completed
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: IBI 360 Injection; Drug: IBI 360 Injection Sintilimab

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215000
      • Innovent Biologics (suzhou) Co. , Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IBI360	Drug: IBI 360 Injection; IBI 360 dose level of escalation IV Q3W Day 1
Experimental: IBI 360 + Sintilimab	Drug: IBI 360 Injection Sintilimab; IBI 360 dose level of escalation IV Q3W Day 1 Sintilimab 200mg IV Q3W Day 1

What is the study measuring?

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
Immunogenicity	Incidence of anti-drug antibodies (ADA) will be measured	up to 90 days following last dose
Efficacy	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
Pharmacokinetics	Area under plasma concentration vs time curve(AUC)	Up to 48 weeks following first dose
Pharmacokinetics	Peak plasma concentration(Cmax)	Up to 48 weeks following first dose
Pharmacokinetics	Up to 48 weeks following first dose	Clearance（CL）
Pharmacokinetics	Apparent volumeof distribution（V）	Up to 48 weeks following first dose
Pharmacokinetics	Terminal Half Life（T1/2）	Up to 48 weeks following first dose

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2021
• Primary Completion (Actual): August 30, 2023
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: September 5, 2021
• First Submitted That Met QC Criteria: September 5, 2021
• First Posted (Actual): September 14, 2021

Study Record Updates

• Last Update Posted (Actual): October 17, 2024
• Last Update Submitted That Met QC Criteria: October 14, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Advanced Solid Tumor
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CIBI360A101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No