Solid TumorPhase 1NCT03757936
A Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Anti-PD-1 Antibody (HLX10) in Combination With Avastin Biosimilar (HLX04) in Patients With Advanced Solid Tumors
A Phase 1 study testing HLX04 and HLX10 in people with Solid Tumor, run by Shanghai Henlius Biotech at 1 site in China.
Trial summary
This is a single-center, open-label, dose-escalation Phase I clinical trial to evaluate the safety and the tolerability of HLX10-HLX04 combination therapy in patients with advanced solid tumors after failure of standard of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- HLX04 and HLX10
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 27 Nov 2018to 27 Dec 2020
- Phase
- Phase 1
- 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 ≥18 years, male or female
- Patient with histologically or cytologically confirmed advanced malignant solid tumors who have failed standard of care, or has no standard-of-care therapy or are not suitable for standard of care at the present stage;
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1；
- Life expectancy greater than 3 months;
- Patient must have at least one measurable tumor lesion as defined by RECIST v1.1; the lesion concerned must not be a bone metastasis if only one target lesion is present;
- Has adequate organ functions;
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- If the subject is a patient with hepatocellular carcinoma, Child-Pugh classification must be A.
- A qualified patient (male or female) of childbearing potential must agree to use reliable contraceptive methods (hormonal, or barrier method or abstinence) for the course of the study and through at least 6 months after the last dose; a female patient of childbearing potential must have negative blood pregnancy test within 7 days prior to enrollment;
- The subject must give his/her informed consent to this study prior to the trial, and voluntarily sign a written informed consent form.
Who cannot join
- Histopathological confirmed head and neck cancer or squamous-cell lung cancer, or bleeding tendency in the tumor lesion judged by the investigator;
- Has received antitumor therapy like radiotherapy, chemotherapy, targeted therapy, endocrinal therapy or immunotherapy, or other clinical study drug therapy within 4 months prior to the initial drug administration;
- Has received a surgical operation on major viscera or experienced apparent trauma within 4 weeks from the initial drug administration, or experienced subcutaneous venous access device implantation within 7 days;
- The adverse reactions which occurred in the previous antitumor treatment were not recovered to ≤ grade 1 based on CTCAE 4.03 assessment (except for hair loss);
- Evidences of metastatic lesion in the patient's central nervous system;
- Previously experienced ≥ grade 3 immune-related adverse event during immunotherapy;
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- Active, or history of autoimmune disease which may relapse (for example, systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.);
- Currently having or have had interstitial lung disease;
- Uncontrollable active infection(s);
- History of immunodeficiency, including HIV antibody positive;
- Known active hepatitis B; or hepatitis C virus infections;
- Has bleeding tendency;
- History of severe cardiovascular diseases;
- Known gastrointestinal diseases as follows:
- Gastrointestinal perforation, abdominal fistula or abdominal abscess within 6 months before signing the informed consent; History of poorly controlled or recurrent inflammatory bowel disease; Active peptic ulcers, or > moderate esophageal varices;
- Known hypersensitivity to Bevacizumab, or other anti-PD-1, anti-PD-L1 monoclonal antibody agents;
- Pregnant or breastfeeding female.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai East Hospital
Shanghai
Jin Li, MD, lijin@csco.org.cn
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Recombinant Anti-PD-1 Humanized Monoclonal Antibody Injection (HLX10) in Combination With Recombinant Anti-VEGF Humanized Monoclonal Antibody Injection (HLX04) in Patients With Advanced Solid Tumors
This is a single-center, open-label, dose-escalation Phase I clinical trial to evaluate the safety and the tolerability of HLX10-HLX04 combination therapy in patients with advanced solid tumors after failure of standard of care.
- Conditions
- Solid Tumor
- Being tested
- HLX04, HLX10
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX04Drug
Recombinant Anti-VEGF Humanized Monoclonal Antibody Injection
HLX10Drug
Recombinant Anti-PD-1 Humanized Monoclonal Antibody Injection
| Study group | Role | What they receive |
|---|---|---|
| HLX04+HLX10 | Experimental | HLX10, at three dose levels (1, 3, 10 mg/kg), to be intravenously injected once every two weeks; HLX04, at a fixed dose of 5 mg/kg, intravenously injected once every two weeks; Study drugs given in combination for up to 2 years or until the disease gets worse, whichever comes first. Receives: Drug: HLX04; Drug: HLX10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of HLX04 plus HLX10 in patients with advanced solid tumors
The MTD is the dose with toxicity rate (estimated by isotonic regression) most approximate to the target one (30%).
Measured: 28 days
Dose Limiting Toxicity (DLT) of HLX04 plus HLX10 in patients with advanced solid tumors
DLT is defined as the occurrence of the following adverse events (unless judged by the investigator to be definitely unrelated to HLX04 or HLX10) within Cycle 1 (i.e., from Cycle 1 Day 1 to Cycle 1 Day 28)
Measured: 28 days
Secondary outcomes (8)
PK parameters of the HLX04 plus HLX10 therapy in patients with advanced solid tumors
Peak Plasma Concentration (Cmax) for single dose and multiple doses
Measured: Day 1 of treatment up to 2 years
PK parameters of the HLX04 plus HLX10 therapy in patients with advanced solid tumors
Area under the plasma concentration versus time curve (AUC) for single dose and multiple doses
Measured: Day 1 of treatment up to 2 years
Objective Response Rate (ORR) of HLX04 plus HLX10 in patients with advanced solid tumors
ORR determined by RECIST criteria
Measured: Day 1 of treatment up to 2 years
Disease Control Rate (DCR) of HLX04 plus HLX10 in patients with advanced solid tumors
DCR determined by RECIST criteria
Measured: Day 1 of treatment up to 2 years
Duration of Response (DOR) of HLX04 plus HLX10 in patients with advanced solid tumors
DOR determined by RECIST criteria
Measured: Day 1 of treatment up to 2 years
Progression-Free Survival (PFS) of HLX04 plus HLX10 in patients with advanced solid tumors
PFS determined by RECIST criteria
Measured: Day 1 of treatment up to 2 years
Overall Survival (OS) of HLX04 plus HLX10 in patients with advanced solid tumors
OS determined by RECIST criteria
Measured: Day 1 of treatment up to 2 years
Immunogenicity
Anti-drug Antibody (ADA) Testing
Measured: Day 1 of treatment 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 posted29 Nov 2018
- Study start27 Nov 2018
- Primary completion27 Sep 2019 (estimated)
- Study completion27 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT03757936
- Sponsor's protocol ID
- HLX10HLX04-001
- Status last verified
- May 2019
- First submitted
- 19 Nov 2018
- Last updated
- 23 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Recombinant Anti-PD-1 Humanized Monoclonal Antibody Injection (HLX10) in Combination With Recombinant Anti-VEGF Humanized Monoclonal Antibody Injection (HLX04) in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT03757936
- Acronym / sponsor ID
- HLX10HLX04-001
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2018 (actual)
- Primary completion
- 27 Sep 2019 (estimated)
- Study completion
- 27 Dec 2020 (estimated)
- First posted
- 29 Nov 2018 (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 a single-center, open-label, dose-escalation Phase I clinical trial to evaluate the safety and the tolerability of HLX10-HLX04 combination therapy in patients with advanced solid tumors after failure of standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HLX04+HLX10 | Experimental | Drug: HLX04, Drug: HLX10HLX10, at three dose levels (1, 3, 10 mg/kg), to be intravenously injected once every two weeks; HLX04, at a fixed dose of 5 mg/kg, intravenously injected once every two weeks; Study drugs given in combination for up to 2 years or until the disease gets worse, whichever comes first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 years, male or female
- Patient with histologically or cytologically confirmed advanced malignant solid tumors who have failed standard of care, or has no standard-of-care therapy or are not suitable for standard of care at the present stage;
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1；
- Life expectancy greater than 3 months;
- Patient must have at least one measurable tumor lesion as defined by RECIST v1.1; the lesion concerned must not be a bone metastasis if only one target lesion is present;
Key exclusion criteria (17 listed)
- Histopathological confirmed head and neck cancer or squamous-cell lung cancer, or bleeding tendency in the tumor lesion judged by the investigator;
- Has received antitumor therapy like radiotherapy, chemotherapy, targeted therapy, endocrinal therapy or immunotherapy, or other clinical study drug therapy within 4 months prior to the initial drug administration;
- Has received a surgical operation on major viscera or experienced apparent trauma within 4 weeks from the initial drug administration, or experienced subcutaneous venous access device implantation within 7 days;
- The adverse reactions which occurred in the previous antitumor treatment were not recovered to ≤ grade 1 based on CTCAE 4.03 assessment (except for hair loss);
- Evidences of metastatic lesion in the patient's central nervous system;
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 |
|---|---|---|
| HLX04Recombinant Anti-VEGF Humanized Monoclonal Antibody Injection | Drug | HLX04+HLX10 |
| HLX10Recombinant Anti-PD-1 Humanized Monoclonal Antibody Injection | Drug | HLX04+HLX10 |
Primary outcome
Maximum Tolerated Dose (MTD) of HLX04 plus HLX10 in patients with advanced solid tumors
Time frame: 28 days
The MTD is the dose with toxicity rate (estimated by isotonic regression) most approximate to the target one (30%).
Dose Limiting Toxicity (DLT) of HLX04 plus HLX10 in patients with advanced solid tumors
Time frame: 28 days
DLT is defined as the occurrence of the following adverse events (unless judged by the investigator to be definitely unrelated to HLX04 or HLX10) within Cycle 1 (i.e., from Cycle 1 Day 1 to Cycle 1 Day 28)
8 secondary outcomes
PK parameters of the HLX04 plus HLX10 therapy in patients with advanced solid tumors
Time frame: Day 1 of treatment up to 2 years
PK parameters of the HLX04 plus HLX10 therapy in patients with advanced solid tumors
Time frame: Day 1 of treatment up to 2 years
Objective Response Rate (ORR) of HLX04 plus HLX10 in patients with advanced solid tumors
Time frame: Day 1 of treatment up to 2 years
Disease Control Rate (DCR) of HLX04 plus HLX10 in patients with advanced solid tumors
Time frame: Day 1 of treatment up to 2 years
Duration of Response (DOR) of HLX04 plus HLX10 in patients with advanced solid tumors
Time frame: Day 1 of treatment up to 2 years
Progression-Free Survival (PFS) of HLX04 plus HLX10 in patients with advanced solid tumors
Time frame: Day 1 of treatment up to 2 years
Overall Survival (OS) of HLX04 plus HLX10 in patients with advanced solid tumors
Time frame: Day 1 of treatment up to 2 years
Immunogenicity
Time frame: Day 1 of treatment 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 23 May 2019.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HLX04 and HLX10 in people with Solid Tumor, 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 9 inclusion and 17 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 23 May 2019. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Joanne Wang (+86-021-33395800-6024, Joanne_wang@henlius.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) of HLX04 plus HLX10 in patients with advanced solid tumors (time frame: 28 days). 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 23 May 2019; AzTrials last refreshed its copy on 29 Oct 2026.