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

NCT06610799 | Recruiting Phase 1

• 1 other identifier: CIBI363Y110
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

IBI363 + Chemotherapy

Outcome Measures

Primary Outcomes (2)

• Objective response rate (ORR)

  The efficacy of solid tumors was evaluated according to RECIST v1.1

  Through out the study (up to 2 years)

• Disease control rate (DCR)

  The efficacy of solid tumors was evaluated according to RECIST v1.1

  Through out the study (up to 2 years)

Secondary Outcomes (3)

• Progression Free Survival（PFS）;

  Up to 2 years

• Overall Survival, OS）

  Up to 2 years

• Adverse Enent (AE), Treatment-Emergent AE (TEAE), Adverse Event of Special Interest (AESI) and Serious Adverse Event (SAE)

  Up to 90 days after the last administration

Study Arms (1)

Cohort 1

EXPERIMENTAL

IBI363 combination with oxaliplatin and capecitabine (XELOX) for first-line treatment of unresectable advanced or metastatic gastric and gastroesophageal junction adenocarcinoma

Drug: IBI363

Interventions

IBI363 DRUG

IBI363 Q3W Oxaliplatin 130 mg/m2，IV，Q3W, Capecitabine ,1000mg/ m2，PO，Bid，d1-14，Q3W

Cohort 1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Women who are pregnant or lactating, or intending to become pregnant before, during, or within 6 months after the last dose of study drug.
• Active uncontrolled bleeding or a known bleeding diathesis.
• 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.

Sponsors & Collaborators

• Xiangdong Cheng: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310000, China

RECRUITING

Central Study Contacts

Yanxi Pu

CONTACT

18523197816; yanxi.pu@innoventbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Secretary of the party committee

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 24, 2024
• Study Start: October 15, 2024
• Primary Completion: June 30, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 20, 2024

Record last verified: 2024-09

Locations

CN (1)