NCT07274813

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

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 254 (estimated)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	HLX37	HLX37 will be administered as an intravenous (IV) infusion.

Timeline

• Start date: 2025-12-29
• Primary completion: 2027-03-30
• Completion: 2028-12-30
• First posted: 2025-12-10
• Last updated: 2026-03-03

Locations

2 sites across 1 country: China