NCT05127759

Brief Summary

The purpose of this study was to assess efficacy, safety and PK in metastatic colorectal cancer (mCRC) given HLX208 (BRAF V600E inhibitor).

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
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2022

Typical duration for phase_2

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

November 9, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 19, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

March 23, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2025

Completed
Last Updated

August 8, 2023

Status Verified

August 1, 2023

Enrollment Period

1.9 years

First QC Date

November 9, 2021

Last Update Submit

August 7, 2023

Conditions

Metastatic Colorectal CancermCRC

Outcome Measures

Primary Outcomes (1)

  • ORR

    Objective response rate(assessed by independent radiological review committee (IRRC) based on the RECIST Version 1.1)

    up to 2 years

Secondary Outcomes (2)

  • PFS

    from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years

  • OS

    from the date of first dose until the date of death from any cause，assessed up to 2 years

Study Arms (1)

HLX208

EXPERIMENTAL

Participants receive HLX208 450mg bid po

Drug: HLX208

Interventions

HLX208DRUG

HLX208 450mg bid po

Also known as: BRAF V600E inhibitor
HLX208

Eligibility Criteria

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

You may qualify if:

  • Age\>=18Y;
  • Good Organ Function;
  • Expected survival time ≥ 3 months;
  • Metastatic/recurrent advanced BRAF V600E mCRC that have been diagnosed histologically and have failed first line treatment;
  • At least one measurable lesion as per RECIST v1.1;
  • ECOG score 0-1.

You may not qualify if:

  • Previous treatment with BRAF inhibitors or MEK inhibitors
  • Symptomatic brain or meningeal metastases (unless the patient has been on \> treatment for 6 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable).
  • Active clinical severe infection;
  • A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liaoning Cancer Hospital

Shenyang, Liaoning, 110042, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

CCT239065

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2021

First Posted

November 19, 2021

Study Start

March 23, 2022

Primary Completion

January 30, 2024

Study Completion

June 28, 2025

Last Updated

August 8, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)