Study of IBI363 in Patients with Advanced First-line Gastric Cancer

November 18, 2024 updated by: Xiangdong Cheng

Phase Ib Study to Evaluate the Safety, Tolerability and Efficacy of IBI363 in Combination with Oxaliplatin and Capecitabine (XELOX) in First-line Treatment of Unresectable Advanced or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma

This is a phase 1b study designed to evaluate the safety, tolerability and efficacy of IBI363 in combination with oxaliplatin and capecitabine (XELOX) in first-line treatment of unresectable advanced or metastatic gastric and gastroesophageal junction adenocarcinoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female subjects, ≥ 18 years and ≤75 years.
  2. Subjects with unresectable advanced or metastatic gastric and gastroesophageal junction adenocarcinoma without prior systematic treatment.
  3. Subjects with at least one measurable lesion according to RECIST v1.1.
  4. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
  5. Expected survival time ≥ 3 months.

Exclusion Criteria:

  1. Women who are pregnant or lactating, or intending to become pregnant before, during, or within 6 months after the last dose of study drug.
  2. Active uncontrolled bleeding or a known bleeding diathesis.
  3. Subjects with history of or known active seizure disorder, brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
IBI363 combination with oxaliplatin and capecitabine (XELOX) for first-line treatment of unresectable advanced or metastatic gastric and gastroesophageal junction adenocarcinoma
Drug: IBI363
IBI363 Q3W Oxaliplatin 130 mg/m2，IV，Q3W, Capecitabine ,1000mg/ m2，PO，Bid，d1-14，Q3W

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: Through out the study (up to 2 years)
The efficacy of solid tumors was evaluated according to RECIST v1.1
Through out the study (up to 2 years)
Disease control rate (DCR)
Time Frame: Through out the study (up to 2 years)
The efficacy of solid tumors was evaluated according to RECIST v1.1
Through out the study (up to 2 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival（PFS）;
Time Frame: Up to 2 years
The efficacy of solid tumors was evaluated according to RECIST v1.1
Up to 2 years
Overall Survival, OS）
Time Frame: Up to 2 years
The efficacy of solid tumors was evaluated according to RECIST v1.1
Up to 2 years
Adverse Enent (AE), Treatment-Emergent AE (TEAE), Adverse Event of Special Interest (AESI) and Serious Adverse Event (SAE)
Time Frame: Up to 90 days after the last administration
Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0.
Up to 90 days after the last administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiangdong Cheng

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

September 18, 2024

First Submitted That Met QC Criteria

September 20, 2024

First Posted (Actual)

September 24, 2024

Study Record Updates

Last Update Posted (Estimated)

November 20, 2024

Last Update Submitted That Met QC Criteria

November 18, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • CIBI363Y110

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on IBI363 + Chemotherapy

Clinical Trials on IBI363

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe