MedTrace Logo

To Evaluate IAH0968 in Combination With CAPEOX in HER2-positive Metastatic Colorectal Cancer

NCT05673512 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 279

Last updated 2024-02-20

No results posted yet for this study

Summary

The Phase IIa of this clinical study, a dose-escalation study of IAH0968 in combination with CAPEOX, is designed for safety and tolerability in subjects with HER2-positive advanced or metastatic solid tumors. Phase IIb/III is an operational seamless adaptive design consisting of two phases. Phase I (Phase IIb) was designed to initially evaluate the efficacy and safety of IAH0968+CAPEOX in HER2-positive subjects with metastatic colorectal cancer, using PFS.

Conditions

  • HER2 Gene Mutation

Interventions

COMBINATION_PRODUCT

Injection of IAH0968 + CAPEOX

PLACEBO+CAPEOX in HER2 positive metastatic colorectal cancer patient

COMBINATION_PRODUCT

PLACEBO+CAPEOX

PLACEBO+CAPEOX in HER2 positive metastatic colorectal cancer patient

Sponsors & Collaborators

  • SUNHO（China）BioPharmaceutical CO., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-12
Primary Completion
2025-03-01
Completion
2026-03-01
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05673512 on ClinicalTrials.gov