Advanced/Metastatic Solid TumorsEarly Phase 1NCT07274813
A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX37 in Advanced/Metastatic Solid Tumors
A Early Phase 1 study testing HLX37 in people with Advanced/Metastatic Solid Tumors and NSCLC, run by Shanghai Henlius Biotech at 2 sites in China.
Trial summary
This study is an open-label first-in-human phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HLX37 in patients with advanced/metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced/Metastatic Solid Tumors, NSCLC
- What is being tested?
- HLX37
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 2 sitesChina
- Study dates
- 29 Dec 2025to 30 Dec 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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
None listed.
Who cannot join
- Subjects who meet any of the following criteria will not be eligible for this study:
- There should be a history of other malignant tumors within 3 years prior to the first medication, except for cured cervical carcinoma in situ or basal cell carcinoma of the skin.
- There have been adverse events in the past that led to the permanent termination of immunotherapy; Or there was a history of grade ≥2 immune-related pneumonia or immune-related myocarditis;
- Has a history of (non-infectious) interstitial lung disease (ILD), and currently still requires steroid drug treatment; Or currently having active ILD, or suspected through imaging researchers at the time of screening that there is a risk of ILD aggravation or that they are not suitable to participate in this study;
- It is known that the subject has had a severe allergic reaction to macromolecular protein preparations/monoclonal antibodies in the past, or is allergic to the components of the test drug preparation;
- Within two weeks before the first medication, there is an active systemic infectious disease that requires intravenous antibiotic treatment;
Show all 23Show fewer
- The subjects have poorly controlled clinical symptoms or diseases of the cardiovascular and cerebrovascular system, including but not limited to: (1) NYHA grade II or above heart failure or left ventricular ejection fraction (LVEF) < 50%; (2) Unstable angina pectoris; (3) Has experienced myocardial infarction or cerebrovascular accident within 6 months (excluding lacunar infarction, mild cerebral ischemia or transient ischemic attack); (4) Poorly controlled arrhythmias (including QTc intervals of ≥ 450 ms in men and ≥ 470 ms in women) (QTc intervals are calculated using the Fridericia formula);
- Subjects who had experienced the following diseases within 12 months prior to the first administration: a history of lower esophageal varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, abdominal abscess or a history of acute gastrointestinal bleeding; Subjects who have experienced the following diseases within 6 months prior to the first administration: any arterial thromboembolic event, NCI CTCAE V.5.0 grade 3 or higher venous thromboembolism, transient ischemic attack, cerebrovascular accident, hypertensive crisis or history of hypertensive encephalopathy, subjects with history of acute exacerbation of chronic obstructive pulmonary disease; Patients currently suffering from hypertension with a systolic blood pressure of ≥160 MMHG or a diastolic blood pressure of ≥100 MMHG after oral antihypertensive drug treatment.
- Known to have meningeal metastasis, or uncontrolled or symptomatic central nervous system (CNS) metastasis, manifested as clinical symptoms, cerebral edema, spinal cord compression and/or progressive growth. Subjects with a history of central nervous system metastasis or spinal cord compression who have clearly received treatment and have been determined by the investigator to have stable clinical manifestations after discontinuing anticonvulsants and steroids for 8 weeks before the start of the study treatment can be enrolled in the study. Untreated, asymptomatic subjects with brain metastases (i.e., those without neurological symptoms, no need for corticosteroid hormones, no long diameter of any brain metastases >1.5 cm, and no obvious edema around the brain metastases) can be enrolled. Brain metastases are not regarded as target lesions.
- There is a known active or suspected autoimmune disease. However, subjects with autoimmune hypothyroidism who have received thyroid hormone replacement therapy are allowed to participate in the study; Allow controlled type 1 diabetes subjects receiving insulin treatment to participate in the study;
- Subjects who have received systemic corticosteroids (prednisone > 10mg/ day or equivalent doses of similar drugs) or other immunosuppressants within 14 days prior to the first administration; Except for the following situations: treatment with topical, ocular, intra-articular, intranasal and inhaled corticosteroids; Short-term use of corticosteroids for preventive treatment in cases such as contrast agents;
- Suffering from active pulmonary tuberculosis;
- Subjects with a history of severe bleeding tendencies or coagulation disorders; Subjects with clinically significant bleeding symptoms within one month before the first administration, including but not limited to gastrointestinal bleeding, hemoptysis (defined as coughing up or expelling ≥1 teaspoon of fresh blood or small blood clots, or only coughing up blood without sputum; those with sputum blood can be included), and epistaxis (excluding epistaxis and bloody reflux mucus); Subjects whose imaging examinations during screening showed that the tumor surrounded important blood vessels or had obvious necrosis and cavities, and the researchers judged that there was a risk of bleeding in participating in the study; Patients with central and cavitary squamous non-small cell lung cancer (according to the researchers' judgment, such patients have a higher risk of bleeding).
- Currently using or having used aspirin (> 325mg/ day) or dipyridamole, clopidine, clopidogrel and cilostazole for treatment within 7 days before the first use.
- Currently in use or under study, full-dose oral or injectable anticoagulant drugs or thrombolytic drugs have been used for therapeutic purposes within 7 days prior to the first administration. Prophylactic anticoagulant therapy is permitted for open intravenous infusion systems, provided that the drug activity is less than 1.5 times the upper limit of normal for the international normalized ratio (INR) and the partial thromboplastin time (APTT) is within the normal range within 14 days prior to the first administration. Prophylactic use of low-molecular-weight heparin (i.e. Enoxaparin 40mg/ day) is permitted.
- Daily administration of non-steroidal anti-inflammatory drugs is required for long-term treatment. Occasional use of NSAIDs is permitted to relieve medical symptoms such as headache or fever
- In the past, when receiving anti-angiogenic therapy, grade ≥3 toxicity related to anti-angiogenic therapy occurred (except for toxicity such as fever that the researchers considered not to pose a safety risk to the subjects).
- Have a history of immune deficiency, including a positive test for the human immunodeficiency virus (HIV), or suffer from other acquired or congenital immune deficiency diseases, or have a history of organ transplantation;
- Active HBV or HCV infection or co-infection: If HBsAg (+) and/or HBcAb (+), HBV-DNA testing is required. The result must be less than 500 IU/mL or less than 2500 copies/mL or less than the upper limit of normal (ULN) for enrollment. For eligible subjects, if HBV-DNA can be detected, it is recommended that they receive nucleoside anti-hepatitis B virus treatment. If the HCV antibody is (+), HCV-RNA must be tested, and the result must be less than the upper limit of normal value (ULN) for enrollment. Subjects with co-infection of hepatitis B and C should be excluded (with positive HBsAg or HBcAb tests and positive HCV antibody tests).
- Have received a live vaccine within 28 days prior to the first administration;
- Pregnant or lactating women;
- The researcher believes that the subjects have any clinical or laboratory test abnormalities or other reasons that make them unsuitable to participate in this clinical study.
- Suffering from local or systemic diseases not caused by malignant diseases; Or diseases or symptoms caused by tumors that may lead to higher medical risks and/or uncertain survival assessment results, such as neoplastic leukemia-like reactions (white blood cell count > 20×109/L), cachexia manifestations (for example, known weight loss of more than 10% within 3 months before screening), etc.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Tianqing Chu contact
China2 sites, 2 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai
Tianqing Chu, Dr, 021-22200000, ctqxkyy@163.com
- Recruiting
The Second Affiliated Hospital of Air Force Medical University of the People's Liberation Army of China
Xi'an
029-84734100, yanxiaolong@fmmu.edu.cn
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of HLX37 (Recombinant Human Bispecific Antibodies Against PD-L1 and VEGF) in Patients With Advanced/Metastatic Solid Tumors
This study is an open-label first-in-human phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HLX37 in patients with advanced/metastatic solid tumors.
Read the detailed description
This study is an open-label first-in-human phase I clinical study to evaluate the safety, tolerability , and pharmacokinetic characteristics of HLX37 with escalated doses in the treatment of patients with advanced/metastatic solid tumors.
In Phase Ia Part 1of this study, a 3 + 3 dose escalation method will be adopted, and the patients will be administered with HLX37 at different doses via intravenous infusion. The DLT observation period lasts for 3 weeks after the first administration of HLX37.
After the DLT observation period of the single-drug ramp-up 20mg/kg dose group ended and the SRC safety assessment was conducted, that is Initiate the Phase Ia Part2 of this study to conduct HLX37 in patients with advanced non-small cell lung cancerThe dosage of combined chemotherapy is increasing. The 3+3 dose escalation method will be adopted, and the subjects will receive different doses. Intravenous infusion administration of HLX37 in combination with chemotherapy (tentatively 10 mg/kg, 20 mg/kg, 30 mg/kg) Or other doses of HLX37 combined with chemotherapy, administered intravenously at Q3W. DLT observation period 3 weeks after the first administration of HLX37 in combination with chemotherapy.
In phase Ib of this study, The Safety Review Committee will recommend dose groups for expansion based on the safety, efficacy and PK data of the dose escalation phase.
- Conditions
- Advanced/Metastatic Solid Tumors, NSCLC
- Being tested
- HLX37
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX37Drug
HLX37 will be administered as an intravenous (IV) infusion.
| Study group | Role | What they receive |
|---|---|---|
| Phase Ia：Dose Escalation | Experimental | A total of seven dose escalations were preset: Dose1, Dose2, Dose3, Dose4, Dose5, Dose6. Receives: Drug: HLX37 |
| Phase Ib：Dose Expansion | Experimental | patients with advanced NSCLC;Participants will receive the RP2D identified in Dose Escalation Study . Receives: Drug: HLX37 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Dose-Limiting Toxicity (DLT) of HLX37 within 21 days after the first Administration
DLT refers to the AEs that are determined to be related to the investigational product by the investigator, whose severity will affect the escalation of dose level. In this study, the DLT observation period lasts for 21 days after the first administration of HLX37.
Measured: From first dose to the end of Cycle 1 (each cycle is 3 weeks)
2. The maximum tolerated dose (MTD) of HLX37
The highest dose level, at which DLT is observed in no more than one of 6 evaluable patients, is defined as MTD of HLX37
Measured: From first dose to the end of Cycle 1 (each cycle is 3 weeks)
Secondary outcomes (5)
Objective response rate (ORR)
Percentage of participants with complete response (CR) and partial response (PR) based on investigator assessment.
Measured: approximately up to 24 months
Duration of response (DOR)
Length of time response continued based on investigator's assessment.
Measured: approximately up to 24 months.
Progression-free survival (PFS)
The PFS is defined as the time from the date of enrollment to the date of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause,whichever occurred first.
Measured: approximately up to 24 months.
Overall survival (OS)
Time from the date of enrollment to the date of death for any cause.
Measured: approximately up to 24 months
Cmax
Maximum serum concentration (Cmax) of HLX37
Measured: Up to 21 days after the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start29 Dec 2025
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced/Metastatic Solid TumorsStudies 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 254 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
- NCT07274813
- Sponsor's protocol ID
- HLX37- FIH101
- Status last verified
- Feb 2026
- First submitted
- 28 Nov 2025
- Last updated
- 3 Mar 2026
- 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 Mar 2026. 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 Pharmacokinetic Characteristics of HLX37 (Recombinant Human Bispecific Antibodies Against PD-L1 and VEGF) in Patients With Advanced/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT07274813
- Acronym / sponsor ID
- HLX37- FIH101
- Conditions
- Advanced/Metastatic Solid Tumors, NSCLC
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 254 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 29 Dec 2025 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 10 Dec 2025 (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 an open-label first-in-human phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HLX37 in patients with advanced/metastatic solid tumors.
Detailed description
This study is an open-label first-in-human phase I clinical study to evaluate the safety, tolerability , and pharmacokinetic characteristics of HLX37 with escalated doses in the treatment of patients with advanced/metastatic solid tumors.
In Phase Ia Part 1of this study, a 3 + 3 dose escalation method will be adopted, and the patients will be administered with HLX37 at different doses via intravenous infusion. The DLT observation period lasts for 3 weeks after the first administration of HLX37.
After the DLT observation period of the single-drug ramp-up 20mg/kg dose group ended and the SRC safety assessment was conducted, that is Initiate the Phase Ia Part2 of this study to conduct HLX37 in patients with advanced non-small cell lung cancerThe dosage of combined chemotherapy is increasing. The 3+3 dose escalation method will be adopted, and the subjects will receive different doses. Intravenous infusion administration of HLX37 in combination with chemotherapy (tentatively 10 mg/kg, 20 mg/kg, 30 mg/kg) Or other doses of HLX37 combined with chemotherapy, administered intravenously at Q3W. DLT observation period 3 weeks after the first administration of HLX37 in combination with chemotherapy.
In phase Ib of this study, The Safety Review Committee will recommend dose groups for expansion based on the safety, efficacy and PK data of the dose escalation phase.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase Ia：Dose Escalation | Experimental | Drug: HLX37A total of seven dose escalations were preset: Dose1, Dose2, Dose3, Dose4, Dose5, Dose6. |
| Phase Ib：Dose Expansion | Experimental | Drug: HLX37patients with advanced NSCLC;Participants will receive the RP2D identified in Dose Escalation Study . |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (23 listed)
- There should be a history of other malignant tumors within 3 years prior to the first medication, except for cured cervical carcinoma in situ or basal cell carcinoma of the skin.
- There have been adverse events in the past that led to the permanent termination of immunotherapy; Or there was a history of grade ≥2 immune-related pneumonia or immune-related myocarditis;
- Has a history of (non-infectious) interstitial lung disease (ILD), and currently still requires steroid drug treatment; Or currently having active ILD, or suspected through imaging researchers at the time of screening that there is a risk of ILD aggravation or that they are not suitable to participate in this study;
- It is known that the subject has had a severe allergic reaction to macromolecular protein preparations/monoclonal antibodies in the past, or is allergic to the components of the test drug preparation;
- Within two weeks before the first medication, there is an active systemic infectious disease that requires intravenous antibiotic treatment;
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 |
|---|---|---|
| HLX37HLX37 will be administered as an intravenous (IV) infusion. | Drug | Phase Ia：Dose Escalation, Phase Ib：Dose Expansion |
Primary outcome
The Dose-Limiting Toxicity (DLT) of HLX37 within 21 days after the first Administration
Time frame: From first dose to the end of Cycle 1 (each cycle is 3 weeks)
DLT refers to the AEs that are determined to be related to the investigational product by the investigator, whose severity will affect the escalation of dose level. In this study, the DLT observation period lasts for 21 days after the first administration of HLX37.
2. The maximum tolerated dose (MTD) of HLX37
Time frame: From first dose to the end of Cycle 1 (each cycle is 3 weeks)
The highest dose level, at which DLT is observed in no more than one of 6 evaluable patients, is defined as MTD of HLX37
5 secondary outcomes
Objective response rate (ORR)
Time frame: approximately up to 24 months
Duration of response (DOR)
Time frame: approximately up to 24 months.
Progression-free survival (PFS)
Time frame: approximately up to 24 months.
Overall survival (OS)
Time frame: approximately up to 24 months
Cmax
Time frame: Up to 21 days after the first dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Advanced/Metastatic Solid Tumors
Not yet recruitingPhase 1
First-in-Human, Multicenter, Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of YL-18319 Monotherapy in Patients With Locally Advanced/Metastatic Solid Tumors
Solid Tumors, Ovarian
RecruitingPhase 2
BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
RecruitingPhase 1
A Study to Find a Suitable Dose of ASP5834 in Adults With Solid Tumors
Solid Tumor, Non-Small-Cell Lung Cancer
RecruitingPhase 1/2
Study of GVV858 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors
RecruitingPhase 1/2
A Study of BL-M08D in Patients With Locally Advanced or Metastatic Melanoma and Other Solid Tumors
Melanoma, Solid Tumors
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.
Tianqing Chu contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing HLX37 in people with Advanced/Metastatic Solid Tumors and NSCLC, 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 0 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 3 Mar 2026. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liya Wan (86+13911662820, Liya_Wan@henlius.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Dose-Limiting Toxicity (DLT) of HLX37 within 21 days after the first Administration (time frame: From first dose to the end of Cycle 1 (each cycle is 3 weeks)). 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 Mar 2026.