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

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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06610799

Enrollment

Registered

2024-09-24

Start date

2024-10-15

Completion date

2026-12-31

Last updated

2024-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IBI363 + Chemotherapy

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.

Interventions

DRUGIBI363

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Progression Free Survival（PFS）;	Up to 2 years	The efficacy of solid tumors was evaluated according to RECIST v1.1
Overall Survival, OS）	Up to 2 years	The efficacy of solid tumors was evaluated according to RECIST v1.1
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	Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0.

Countries

China

Contacts

Primary ContactYanxi Pu

yanxi.pu@innoventbio.com18523197816

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026