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

Locally Advanced or Metastatic Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05360381
• Other study ID #: HLX35-FIH101
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: June 3, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: August 2023
• Source: Shanghai Henlius Biotech
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 82
• Est. completion date: December 30, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Locally Advanced or Metastatic Solid Tumors
• Squamous-cell Non-small Cell Lung Cancer

Intervention

Drug:
• HLX35
A Recombinant Human Anti-EGFR and Anti-4-1BB Bispecific Antibody, HLX35 will be administered as a single intravenous (IV) infusion on Day 1 in each 14-day cycle

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai
China	THE Affiliated Hospital of Xuzhou Medical University	Xuzhou

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Henlius Biotech

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Related Adverse Events		2 years
Primary	The proportion of patients experiencing dose limiting toxicity (DLT) events		from first dose to the end of Cycle 2 (each cycle is 14 days)
Primary	The maximum tolerated dose (MTD)		from first dose to the end of Cycle 2 (each cycle is 14 days)
Primary	Recommended phase 2 dose (RP2D)		from first dose to the end of Cycle 2 (each cycle is 14 days)
Secondary	Peak plasma concentration (Cmax) of HLX35		2 years
Secondary	Time to peak (Tmax) of HLX35		2 years
Secondary	Area under the concentration-time curve (AUC) of HLX35		2 years
Secondary	Elimination half-life (t1/2) of HLX35		2 years
Secondary	Clearance (CL) of HLX35		2 years
Secondary	Volume of distribution (Vz) of HLX35		2 years
Secondary	Accumulation Index (Rac) of HLX35		2 years
Secondary	4-1BB receptor occupancy on circulating T cells		2 years
Secondary	The level of 4-1BB in serum		2 years
Secondary	Incidence of treatment-emergent anti-drug antibodies (ADA)		2 years
Secondary	Objective response rate (ORR)		2 years
Secondary	Disease control rate (DCR)		2 years
Secondary	Duration of response (DOR)		2 years