A Study of IBI351 in Combination With Cetuximab in Subjects With KRAS G12C Mutated Metastatic Colorectal Cancer

Phase 1TerminatedNCT05497336

Innovent Biologics (Suzhou) Co. Ltd.8 enrolled

Overview

Phase 1b consists of combined dose escalation phase and dose expansion phase. Phase 3 study will compare efficacy and safety of IBI351 combined with cetuximab versus chemotherapy in treatment of KRAS G12C-mutated metastatic colorectal cancer

A Phase 1b study of the safety, tolerability and preliminary efficacy of IBI351 combined with cetuximab in the treatment of KRAS G12C mutant metastatic colorectal cancer will be conducted based on recommended dose of IBI351, which consists of combined dose escalation phase and dose expansion phase. After confirming the efficacy and safety of IBI351 combined with cetuximab in Phase Ib, an open-label Phase 3 study of the efficacy and safety of IBI351 combined with cetuximab versus oxaliplatin-based mFOLFOX6 regimen or irinotecan-based FOLFIRI with or without bevacizumab in treatment of KRAS G12C-mutated metastatic colorectal cancer will be conducted.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colorectal Cancer

Interventions

IBI351DRUG

IBI351 is administered orally

CetuximabDRUG

Cetuximab is administered intravenously

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. male or female subjects, ≥ 18 years and ≤ 75 years 2. have documentation of KRAS G12C mutation 3. at least one measurable lesion per RECISTv1.1 4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1. 5. life expectancy of \>12 weeks, in the opinion of the investigator Exclusion Criteria: 1. history of deep venous thrombosis or any other serious thromboembolism within 3 months prior to enrollment.. 2. history of radiation-induced pneumonitis, idiopathic pneumonia, active pneumonia, pulmonary fibrosis, diffuse pulmonary interstitial disease, or organizing pneumonia. 3. surgical procedures (excluding needle biopsy) performed within 28 days prior to enrollment that may affect the dosing or study assessments in this study. 4. received therapeutic or palliative radiation therapy within 14 days prior to enrollment 5. pregnant or lactating women

Locations (1)

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Outcomes

Primary Outcomes

Incidence of DLTs (Dose-limiting Toxicity) in the Combined Dose Escalation Phase

Time frame: 28 days during the first 4-week cycle

Objective response rate (ORR)

Time frame: Up to 1 year

Secondary Outcomes

incidence of serious treatment-emergent AEs (TEAEs) , treatment-related adverse event(TRAE), adverse events (SAEs)