HLX35(EGFR×4-1BB Bispecific) in Patients With Advanced or Metastatic Solid Tumors

H

Henlius Pharmaceuticals

Status and phase

Active, not recruiting
Phase 1

Conditions

Locally Advanced or Metastatic Solid Tumors
Squamous-cell Non-small Cell Lung Cancer

Treatments

Drug: HLX35

Study type

Interventional

Funder types

Industry

Identifiers

NCT05360381
HLX35-FIH101

Details and patient eligibility

About

This Phase1, multicenter, first-in-human, open-label, dose-escalation, and dose expansion study will evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy of HLX35 administered as a single-agent by IV infusion every 2 weeks to patients with locally advanced or metastatic solid malignancies, who have failed or are intolerant to standard therapy, or for whom no standard therapy is available. This study has two parts: phase 1a dose escalation and phase 1b dose expansion.

Enrollment

82 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF);
  • Age ≥ 18 years;
  • Phase 1a dose escalation: patients must have histologically or cytologically confirmed malignant solid tumors which are advanced or metastatic, have failed prior standard treatment, and be intolerant or ineligible for standard therapy;
  • Phase 1b dose expansion: patients must have a histological or cytological diagnosis of Squamous Non-Small Cell Lung Cancer (EGFR H score ≥200 confirmed by central lab) which is advanced or metastatic, have failed prior standard treatment, and be intolerant or ineligible for standard therapy;
  • Measurable disease according to RECIST Version 1.1;
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
  • Expected survival 12 weeks;
  • Adequate organ function;

Exclusion criteria

  • Systemic anti-cancer treatment or investigational agents in the 28 days prior to the first study dosing;
  • Patients who still have persistent ≥ grade 2 toxicities from prior therapies;
  • Active CNS metastasis;
  • History of any secondary malignancy in the past 5 years;
  • Active autoimmune disease;
  • Human immunodeficiency virus (HIV) infection;

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

82 participants in 2 patient groups

Phase 1a dose-escalation stage
Experimental group
Description:
Phase 1a uses the "3+3" design, to investigate the safety and determine the MTD of HLX35. Seven dose levels of 0.015 mg/kg, 0.05 mg/kg, 0.1 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg, and 10 mg/kg are planned for dose finding. Enrollment will continue until a maximum of 42 patients are enrolled
Treatment:
Drug: HLX35
Phase 1b dose-expansion stage
Experimental group
Description:
Patients with sqNSCLC (EGFR H score≥200) will be enrolled in two expansion cohorts, at doses equal to or lower than the MTD, to better characterize the safety, tolerability, PK variability, and preliminary efficacy of single-agent HLX35. Phase 1b dose expansion will include 15-20 per-protocol treated patients, as defined above, in each of the two expansion cohorts.
Treatment:
Drug: HLX35

Trial contacts and locations

2

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Central trial contact

Xuhui Hu, MD

Data sourced from clinicaltrials.gov

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