CRCPhase 2NCT05239650
Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07+HLX10 +mFOLFOX6 or HLX07 Monotherapy in Patients With mCRC
A Phase 2 study testing HLX07, HLX10 and mFOLFOX6 in people with CRC, run by Shanghai Henlius Biotech.
Trial summary
This is An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) + HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) + mFOLFOX6 or HLX07 Monotherapy in Patients with Metastatic Colorectal Cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- CRC
- What is being tested?
- HLX07, HLX10 and mFOLFOX6
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2022to 15 Oct 2026
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>=18Y and ≤75Y
- Good Organ Function
- Expected survival time ≥ 3 months
- mCRC that have been diagnosed histologically
- KRAS/NRAS/BRAF WT verified by PCR or NGS of tumor tissue
- ECOG score 0-1;
Who cannot join
- HIV infection
- 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
No sites are listed yet.
About this study
Official title: An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) + HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) + mFOLFOX6 or HLX07 Monotherapy in Patients With Metastatic Colorectal Cancer
This is An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) + HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) + mFOLFOX6 or HLX07 Monotherapy in Patients with Metastatic Colorectal Cancer.
- Conditions
- CRC
- Being tested
- HLX07, HLX10, mFOLFOX6
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX07Drug
1000mg
HLX10Drug
200mg
mFOLFOX6Drug
OXA：85 mg/m2;LV:400 mg/m2；5-FU：400 mg/m2
| Study group | Role | What they receive |
|---|---|---|
| A：1L treatment | Experimental | HLX07 * 1000 mg+HLX10* 200mg +mFOLFOX6, IV, Q2W Receives: Drug: HLX07; Drug: HLX10; Drug: mFOLFOX6 |
| B：≥2L treatment | Experimental | HLX07 *1000 mg monotherapy,IV, Q2W Receives: Drug: HLX07 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective response rate (assessed by investigator per RECIST V1.1)
Measured: up to 3 years
PFS
Progression-free survival (PFS) (assessed by the investigator per RECIST v1.1 )
Measured: : from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier)，up to 3 years
Secondary outcomes (1)
OS
Overall Survival
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start15 Jul 2022 (estimated)
- Primary completion15 Oct 2025 (estimated)
- Study completion15 Oct 2026 (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
- Single group
- 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
- Investigators
- Peng Junjie, Principal investigator, Fudan University Affiliated Oncology Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05239650
- Sponsor's protocol ID
- HLX07-mCRC201
- Status last verified
- Feb 2022
- First submitted
- 7 Feb 2022
- Last updated
- 3 May 2022
- Results posted
- 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 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) + HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) + mFOLFOX6 or HLX07 Monotherapy in Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05239650
- Acronym / sponsor ID
- HLX07-mCRC201
- 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
- 15 Jul 2022 (estimated)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 15 Feb 2022 (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.
This is An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) + HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) + mFOLFOX6 or HLX07 Monotherapy in Patients with Metastatic Colorectal Cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A：1L treatment | Experimental | Drug: HLX07, Drug: HLX10, Drug: mFOLFOX6HLX07 * 1000 mg+HLX10* 200mg +mFOLFOX6, IV, Q2W |
| B：≥2L treatment | Experimental | Drug: HLX07HLX07 *1000 mg monotherapy,IV, Q2W |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age>=18Y and ≤75Y
- Good Organ Function
- Expected survival time ≥ 3 months
- mCRC that have been diagnosed histologically
- KRAS/NRAS/BRAF WT verified by PCR or NGS of tumor tissue
Key exclusion criteria (3 listed)
- HIV infection
- 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 |
|---|---|---|
| HLX071000mg | Drug | A：1L treatment, B：≥2L treatment |
| HLX10200mg | Drug | A：1L treatment |
| mFOLFOX6OXA：85 mg/m2;LV:400 mg/m2；5-FU：400 mg/m2 | Drug | A：1L treatment |
Primary outcome
ORR
Time frame: up to 3 years
Objective response rate (assessed by investigator per RECIST V1.1)
PFS
Time frame: : from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier)，up to 3 years
Progression-free survival (PFS) (assessed by the investigator per RECIST v1.1 )
1 secondary outcome
OS
Time frame: up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
- 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.
Peng Junjie principal investigator
Fudan University Affiliated Oncology Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HLX07, HLX10 and mFOLFOX6 in people with CRC, run by Shanghai Henlius Biotech.
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 6 inclusion and 3 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 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Peng Junjie (: 86021-64175590, junjiepeng67@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: up to 3 years). The study lists 2 primary outcomes in all. 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 3 May 2022.