A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX37 in Advanced/Metastatic Solid Tumors

NCT07274813 | Recruiting Early Phase 1

• 1 other identifier: HLX37- FIH101
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

NSCLC; Advanced/Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  From first dose to the end of Cycle 1 (each cycle is 3 weeks)

Secondary Outcomes (5)

• Objective response rate (ORR)

  approximately up to 24 months

• Duration of response (DOR)

  approximately up to 24 months.

• Progression-free survival (PFS)

  approximately up to 24 months.

• Overall survival (OS)

  approximately up to 24 months

• Cmax

  Up to 21 days after the first dose

Study Arms (2)

Phase Ia：Dose Escalation

EXPERIMENTAL

A total of seven dose escalations were preset: Dose1, Dose2, Dose3, Dose4, Dose5, Dose6.

Drug: HLX37

Phase Ib：Dose Expansion

EXPERIMENTAL

patients with advanced NSCLC;Participants will receive the RP2D identified in Dose Escalation Study .

Drug: HLX37

Interventions

HLX37 DRUG

HLX37 will be administered as an intravenous (IV) infusion.

Phase Ia：Dose Escalation; Phase Ib：Dose Expansion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

Study Sites (2)

Shanghai Chest Hospital

Shanghai, China

RECRUITING

The Second Affiliated Hospital of Air Force Medical University of the People's Liberation Army of China

Xi'an, China

RECRUITING

Central Study Contacts

Liya Wan

CONTACT

86+13911662820; Liya_Wan@henlius.com

Tianqing Chu

CONTACT

021-22200000

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 10, 2025
• Study Start: December 29, 2025
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): December 30, 2028
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)