A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX43 in Advanced/Metastatic Solid Tumors

Conditions

• Advanced/Metastatic Malignant Solid Tumors

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• HLX43 — DRUG
  Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), until progressive disease (PD) without any clinical benefit, initiation of other anti-tumor therapies, death, intolerable toxicity, or withdraw the informed consent (whichever occurs first).
• HLX10 — DRUG
  All participants will receive serplulimab (300 mg Q3W) via intravenous infusion (IV) until PD without clinical benefits, initiation of new anti-tumor therapy, death, intolerable toxicity, or withdrawal of informed consent (whichever occurs first), and serplulimab will be administered for up to 2 years (35 dosing cycles).

Study Details

This study is an open-label first-in-human phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HLX43 in patients with advanced/metastatic solid tumors.

Key Dates

Start date

Nov 24, 2023

Status verified

May 2026

Primary completion

Jun 30, 2026

Completion

Nov 30, 2027

Study Design

Enrollment

367 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ia (Dose Escalation)
  Patients with advanced/metastatic solid tumors
• Experimental: NSCLC failed to standard treatment (Part 2 Dose Expansion)
  Patients with advanced/metastatic NSCLC, who are refractory to standard treatment, or for which no standard treatment is available.
• Experimental: Thymic carcinoma (Part 2 Dose Expansion)
  Patients with advanced/metastatic Thymic carcinoma, who are refractory to first line platinum based standard treatment.
• Experimental: NSCLC failed to standard and docetaxel treatment (Part 2 Dose Expansion)
  Patients with advanced/metastatic NSCLC, who are refractory to standard treatment and docetaxel.
• Experimental: Stage IIIB, IIIC, or IV NSCLC without any prior treatment (Part 2 Dose Expansion)
  Patients with stage IIIB, IIIC, or IV NSCLC that cannot be treated with surgery or radiotherapy, positive PD-L1 expression and no EGFR sensitizing mutation or ALK/ROS gene rearrangement, no previous systemic anti-tumor therapy for NSCLC.

Primary Outcome Measure

The Dose-Limiting Toxicity (DLT) of HLX43 within 21 days after the first Administration [ Time Frame: From first dose to the end of Cycle 1 (each cycle is 3 weeks) ]

Locations (3)

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