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NCT05360381 | Active, not recruiting | Locally Advanced or Metastatic Solid Tumors

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

Shanghai henliushuibiotech

Brief Summary:

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.

Condition or disease

Locally Advanced or Metastatic Solid Tumors

Squamous-cell Non-small Cell Lung Cancer

Intervention/treatment

HLX35

Phase

Phase 1

Study Type : Interventional
Estimated Enrollment : 82 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics and Initial Efficacy of HLX35 (Recombinant Human Anti-EGFR and Anti-4-1BB Bispecific Antibody) in Patients With Advanced or Metastatic Solid Tumors
Actual Study Start Date : June 3, 2022
Estimated Primary Completion Date : October 30, 2024
Estimated Study Completion Date : December 30, 2024
Arm Intervention/treatment

Experimental: Phase 1a dose-escalation stage

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

Drug: HLX35

Experimental: Phase 1b dose-expansion stage

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.

Drug: HLX35
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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;
HLX35(EGFR×4-1BB Bispecific) in Patients With Advanced or Metastatic Solid Tumors

Location Details

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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

China,

F Udanuniversity Shanghai cancer center

Shanghai, China, 200000

Not yet recruiting

China,

THE Affiliated Hospital of Xuzhou Medical University

Xuzhou, China,