Gastric Cancer (GC) Gastroesophageal Junction Cancer (GEJ)Phase 2NCT05246982
HLX07+HLX10+Chemotherapy or HLX07 Monotherapy in Patients With Advanced Metastatic Gastric Cancer
A Phase 2 study testing HLX07+HLX10+oxaliplatin+capecitabine and HLX07 in people with Gastric Cancer (GC) Gastroesophageal Junction Cancer (GEJ), run by Shanghai Henlius Biotech at 2 sites in China.
Trial summary
This study is conducted in patients with advanced metastatic gastric cancer including gastroesophageal junction cancer. This study includes two arms: A and B. Arm A (patients with HER2 negative and PD-L1 CPS≥5 ) will receive HLX07 combination therapy with HLX10 and chemotherapy (oxaliplatin+capecitabine) as first-line… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer (GC) Gastroesophageal Junction Cancer (GEJ)
- What is being tested?
- HLX07+HLX10+oxaliplatin+capecitabine and HLX07
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesChina
- Study dates
- 23 Mar 2022to 30 Mar 2024
- 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
- Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF); be willing to follow and be able to complete all study procedures;
- Age ≥ 18 years and ≤ 75 years when ICF is signed;
- Unresectable locally advanced, or metastatic gastric cancer including gastroesophageal junction cancer, and histopathologically confirmed diagnosis of adenocarcinoma;
- Arm A: never received systemic anti-tumor drug therapy before, with HER2 negative and PD-L1 CPS≥5; Arm B: failed to prior systemic anti-tumor therapy (at least 2 lines);
- Measurable lesion according to RECIST v1.1 by IRRC;
- ECOG score 0-1;
- Expected survival 12 weeks.
Who cannot join
- Has other active malignancies within 5 years before the first administration of the study drug;
- Plan to or have previously received organ or bone marrow transplantation;
- Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage;
- Arm A: previously received antibody drugs against immune checkpoints (such as PD-1, PD-L1, CTLA4, etc.) and / or antibody drugs against EGFR; Arm B: previously received antibody drug treatment against EGFR;
- Have received any research drugs within 14 days before the first use of the study drugs.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Fudan University shanghai cancer center
Shanghai, 200000
Dazhi Xu, MD, 021-64175590, xudzh@shca.org.cn
- Recruiting
Gansu Wuwei Tumor Hospital
Wuwei, Gansu, 730000
Peng Nie, MD, 0935-2268166, nie.peng2008@163.com
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) + Chemotherapy or HLX07 Monotherapy in Patients With Advanced Metastatic Gastric Cancer
This study is conducted in patients with advanced metastatic gastric cancer including gastroesophageal junction cancer. This study includes two arms: A and B. Arm A (patients with HER2 negative and PD-L1 CPS≥5 ) will receive HLX07 combination therapy with HLX10 and chemotherapy (oxaliplatin+capecitabine) as first-line treatment. Arm B will receive HLX07 monotherapy as third-line or above treatment. All of eligible patients will receive study drug treatment until loss of clinical benefit, unacceptable toxicity, death, withdrawal of informed consent (whichever occurs first, HLX10 treatment up to 2 years).
- Being tested
- HLX07+HLX10+oxaliplatin+capecitabine, HLX07
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX07+HLX10+oxaliplatin+capecitabineDrug
HLX07 1500mg+HLX10 300mg+oxaliplatin 130mg/m2+capecitabine 1000mg/m2 q3w
HLX07Drug
HLX07 1500mg q3w
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | HER2 negative and PD-L1 CPS≥5, as first-line therapy Receives: Drug: HLX07+HLX10+oxaliplatin+capecitabine |
| Arm B | Experimental | As third-line or above therapy Receives: Drug: HLX07 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective response rate by IRRC assessment per RECIST 1.1
Measured: Up to 2 years
PFS
Progression-free survival by IRRC assessment per RECIST 1.1
Measured: From the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier), assessed up to 2 years
Secondary outcomes (4)
OS
Overall survival
Measured: From the date of first dose unitl the date of death from any cause，assessed up to 2 years
ORR
Objective response rate by INV assessment per RECIST 1.1
Measured: Up to 2 years
PFS
Objective response rate by INV assessment per RECIST 1.1
Measured: From the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier), assessed up to 2 years
DOR
Duration of response by IRRC/INV assessment per RECIST 1.1
Measured: From the date when CR or PR (whichever recorded earlier) is firstly achieved until the date when disease progression or death is firstly recorded (whichever occurs earlier),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 posted18 Feb 2022
- Study start23 Mar 2022
- Primary completion20 Dec 2023 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer (GC) Gastroesophageal Junction Cancer (GEJ)Studies 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
- 40 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
- NCT05246982
- Sponsor's protocol ID
- HLX07-GC201
- Status last verified
- Feb 2022
- First submitted
- 16 Feb 2022
- Last updated
- 2 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 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) + Chemotherapy or HLX07 Monotherapy in Patients With Advanced Metastatic Gastric Cancer
- ClinicalTrials.gov ID
- NCT05246982
- Acronym / sponsor ID
- HLX07-GC201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 20 Dec 2023 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 18 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 study is conducted in patients with advanced metastatic gastric cancer including gastroesophageal junction cancer. This study includes two arms: A and B. Arm A (patients with HER2 negative and PD-L1 CPS≥5 ) will receive HLX07 combination therapy with HLX10 and chemotherapy (oxaliplatin+capecitabine) as first-line treatment. Arm B will receive HLX07 monotherapy as third-line or above treatment. All of eligible patients will receive study drug treatment until loss of clinical benefit, unacceptable toxicity, death, withdrawal of informed consent (whichever occurs first, HLX10 treatment up to 2 years).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: HLX07+HLX10+oxaliplatin+capecitabineHER2 negative and PD-L1 CPS≥5, as first-line therapy |
| Arm B | Experimental | Drug: HLX07As third-line or above therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF); be willing to follow and be able to complete all study procedures;
- Age ≥ 18 years and ≤ 75 years when ICF is signed;
- Unresectable locally advanced, or metastatic gastric cancer including gastroesophageal junction cancer, and histopathologically confirmed diagnosis of adenocarcinoma;
- Arm A: never received systemic anti-tumor drug therapy before, with HER2 negative and PD-L1 CPS≥5; Arm B: failed to prior systemic anti-tumor therapy (at least 2 lines);
- Measurable lesion according to RECIST v1.1 by IRRC;
Key exclusion criteria (5 listed)
- Has other active malignancies within 5 years before the first administration of the study drug;
- Plan to or have previously received organ or bone marrow transplantation;
- Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage;
- Arm A: previously received antibody drugs against immune checkpoints (such as PD-1, PD-L1, CTLA4, etc.) and / or antibody drugs against EGFR; Arm B: previously received antibody drug treatment against EGFR;
- Have received any research drugs within 14 days before the first use of the study drugs.
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 |
|---|---|---|
| HLX07+HLX10+oxaliplatin+capecitabineHLX07 1500mg+HLX10 300mg+oxaliplatin 130mg/m2+capecitabine 1000mg/m2 q3w | Drug | Arm A |
| HLX07HLX07 1500mg q3w | Drug | Arm B |
Primary outcome
ORR
Time frame: Up to 2 years
Objective response rate by IRRC assessment per RECIST 1.1
PFS
Time frame: From the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier), assessed up to 2 years
Progression-free survival by IRRC assessment per RECIST 1.1
4 secondary outcomes
OS
Time frame: From the date of first dose unitl the date of death from any cause，assessed up to 2 years
ORR
Time frame: Up to 2 years
PFS
Time frame: From the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier), assessed up to 2 years
DOR
Time frame: From the date when CR or PR (whichever recorded earlier) is firstly achieved until the date when disease progression or death is firstly recorded (whichever occurs earlier),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 2 May 2022.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HLX07+HLX10+oxaliplatin+capecitabine and HLX07 in people with Gastric Cancer (GC) Gastroesophageal Junction Cancer (GEJ), run by Shanghai Henlius Biotech at 2 sites 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 7 inclusion and 5 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 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Dazhi Xu, MD (021-64175590, xudzh@shca.org.cn), 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 2 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 2 May 2022.