CRCPhase 2NCT04984369
The Efficacy of HLX208 (BRAF V600E Inhibitor) With Cetuximab for Metastatic Colorectal Cancer (mCRC) With BRAF V600E Mutation After First-line Treatment
A Phase 2 study testing HLX208 and Cetuximab Injection [Erbitux] in people with CRC, run by Shanghai Henlius Biotech at 1 site in China.
Trial summary
An open, multicenter phase II clinical study to evaluate safety and efficacy of HLX208 (BRAF V600E inhibitor) combined with cetuximab for metastatic colorectal cancer (mCRC) with BRAF V600E Mutation after first-line treatment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CRC
- What is being tested?
- HLX208 and Cetuximab Injection [Erbitux]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 11 Aug 2021to 15 Jan 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>=18Y
- Good Organ Function
- Expected survival time ≥ 3 months
- Metastatic/recurrent advanced BRAF+ mCRC that have been diagnosed histologically and have failed first line treatment
- ECOG score 0-1;
Who cannot join
- arm 1 ： Previous treatment with BRAF inhibitors or MEK inhibitors
- Symptomatic brain or meningeal metastases (unless the patient has been on > treatment for 3 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open, Multicenter Phase II Clinical Study to Evaluate Safety and Efficacy of HLX208 (BRAF V600E Inhibitor) Combined With Cetuximab in Patients With Metastatic Colorectal Cancer (mCRC)
An open, multicenter phase II clinical study to evaluate safety and efficacy of HLX208 (BRAF V600E inhibitor) combined with cetuximab for metastatic colorectal cancer (mCRC) with BRAF V600E Mutation after first-line treatment
- Conditions
- CRC
- Being tested
- HLX208, Cetuximab Injection [Erbitux]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX208Drug
Also called BRAF V600E inhibitor
HLX208 450mg bid po OR 600mg bid po OR 900mg bid po
Cetuximab Injection [Erbitux]Drug
Cetuximab 500 mg/m2 IV Q2W
| Study group | Role | What they receive |
|---|---|---|
| Never use other BRAF inhibitor therapy | Experimental | Never use other BRAF inhibitor therapy Receives: Drug: HLX208; Drug: Cetuximab Injection [Erbitux] |
| PD after other BRAF inhibitor therapy N=5~40 | Experimental | PD after other BRAF inhibitor therapy Receives: Drug: HLX208; Drug: Cetuximab Injection [Erbitux] |
| SD but intolerant after other BRAF inhibitor therapy | Experimental | SD but intolerant after other BRAF inhibitor therapy Receives: Drug: HLX208; Drug: Cetuximab Injection [Erbitux] |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective response rate(assessed by independent radiological review committee (IRRC) based on the RECIST Version 1.1)
Measured: up to 2 years
Secondary outcomes (2)
PFS
Progression-free survival (PFS) (assessed by IRRC and the investigator as per RECIST v1.1 )
Measured: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years]
OS
Overall survival
Measured: from the date of first dose until the date of death from any cause，assessed up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start11 Aug 2021
- Primary completion15 Jun 2024 (estimated)
- Study completion15 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CRCStudies of the same condition, open and under way.
- More trials run by Shanghai Henlius BiotechThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04984369
- Sponsor's protocol ID
- HLX208-mCRC201（BECOMES）
- Status last verified
- Aug 2023
- First submitted
- 27 Jul 2021
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Multicenter Phase II Clinical Study to Evaluate Safety and Efficacy of HLX208 (BRAF V600E Inhibitor) Combined With Cetuximab in Patients With Metastatic Colorectal Cancer (mCRC)
- ClinicalTrials.gov ID
- NCT04984369
- Acronym / sponsor ID
- HLX208-mCRC201（BECOMES）
- Conditions
- CRC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- 15 Jun 2024 (estimated)
- Study completion
- 15 Jan 2025 (estimated)
- First posted
- 30 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open, multicenter phase II clinical study to evaluate safety and efficacy of HLX208 (BRAF V600E inhibitor) combined with cetuximab for metastatic colorectal cancer (mCRC) with BRAF V600E Mutation after first-line treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Never use other BRAF inhibitor therapy | Experimental | Drug: HLX208, Drug: Cetuximab Injection [Erbitux]Never use other BRAF inhibitor therapy |
| PD after other BRAF inhibitor therapy N=5~40 | Experimental | Drug: HLX208, Drug: Cetuximab Injection [Erbitux]PD after other BRAF inhibitor therapy |
| SD but intolerant after other BRAF inhibitor therapy | Experimental | Drug: HLX208, Drug: Cetuximab Injection [Erbitux]SD but intolerant after other BRAF inhibitor therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age>=18Y
- Good Organ Function
- Expected survival time ≥ 3 months
- Metastatic/recurrent advanced BRAF+ mCRC that have been diagnosed histologically and have failed first line treatment
- ECOG score 0-1;
Key exclusion criteria (4 listed)
- arm 1 ： Previous treatment with BRAF inhibitors or MEK inhibitors
- Symptomatic brain or meningeal metastases (unless the patient has been on > treatment for 3 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HLX208Also: BRAF V600E inhibitorHLX208 450mg bid po OR 600mg bid po OR 900mg bid po | Drug | Never use other BRAF inhibitor therapy, PD after other BRAF inhibitor therapy N=5~40, SD but intolerant after other BRAF inhibitor therapy |
| Cetuximab Injection [Erbitux]Cetuximab 500 mg/m2 IV Q2W | Drug | Never use other BRAF inhibitor therapy, PD after other BRAF inhibitor therapy N=5~40, SD but intolerant after other BRAF inhibitor therapy |
Primary outcome
ORR
Time frame: up to 2 years
Objective response rate(assessed by independent radiological review committee (IRRC) based on the RECIST Version 1.1)
2 secondary outcomes
PFS
Time frame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years]
OS
Time frame: from the date of first dose until the date of death from any cause，assessed up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HLX208 and Cetuximab Injection [Erbitux] in people with CRC, run by Shanghai Henlius Biotech at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.