NCT05497336

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for phase_1 colorectal-cancer

Timeline
Completed

Started Aug 2022

Shorter than P25 for phase_1 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 11, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

August 18, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

September 30, 2022

Status Verified

September 1, 2022

Enrollment Period

1 year

First QC Date

August 9, 2022

Last Update Submit

September 28, 2022

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

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

    28 days during the first 4-week cycle

  • Objective response rate (ORR)

    Up to 1 year

Secondary Outcomes (6)

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

    up to 30 days after the last administration

  • Number of participants with abnormality in vital signs

    up to 30 days after the last administration

  • Number of participants with abnormality in hematology parameters

    up to 30 days after the last administration

  • Number of participants with abnormality in clinical chemistry parameters

    up to 30 days after the last administration

  • Number of participants with abnormality in routine urinalysis parameters

    up to 30 days after the last administration

  • +1 more secondary outcomes

Study Arms (2)

IBI351+Cetuximab

EXPERIMENTAL

IBI351 recommended dose+Cetuximab 500mg/m2 IV Q2W

Drug: IBI351Drug: Cetuximab

IBI351

EXPERIMENTAL

IBI351 recommended dose

Drug: IBI351

Interventions

IBI351DRUG

IBI351 is administered orally

Also known as: GFH925
IBI351IBI351+Cetuximab
CetuximabDRUG

Cetuximab is administered intravenously

Also known as: Erbitux
IBI351+Cetuximab

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male or female subjects, ≥ 18 years and ≤ 75 years
  • have documentation of KRAS G12C mutation
  • at least one measurable lesion per RECISTv1.1
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
  • life expectancy of \>12 weeks, in the opinion of the investigator

You may not qualify if:

  • history of deep venous thrombosis or any other serious thromboembolism within 3 months prior to enrollment..
  • history of radiation-induced pneumonitis, idiopathic pneumonia, active pneumonia, pulmonary fibrosis, diffuse pulmonary interstitial disease, or organizing pneumonia.
  • surgical procedures (excluding needle biopsy) performed within 28 days prior to enrollment that may affect the dosing or study assessments in this study.
  • received therapeutic or palliative radiation therapy within 14 days prior to enrollment
  • pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Central Study Contacts

Chunxian Hu

CONTACT

0512-69566088chunxian.hu@innoventbio.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2022

First Posted

August 11, 2022

Study Start

August 18, 2022

Primary Completion

August 30, 2023

Study Completion

September 30, 2024

Last Updated

September 30, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)