HS-20089 Combination Treatment in Subjects With Advanced Solid Tumors

Sponsor
Hansoh BioMedical R&D Company
Study ID
NCT06336707
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HS-20089 — DRUG
    Intravenous infusion
  • Adebrelimab — DRUG
    Intravenous infusion
  • Bevacizumab — DRUG
    Intravenous infusion
  • Cisplatin / carboplatin — DRUG
    Intravenous infusion

Study Details

HS-20089 is an investigational antibody-drug conjugate (ADC) composed of a humanized IgG1 anti-B7-H4 monoclonal antibody conjugated to the topoisomerase I inhibitor payload via a protease-cleavable linker, with an average drug-to-antibody ratio of about 6. This is a phase Ⅰ, open-label, multi-center study to evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of HS-20089 in combination with other antitumor agents (Adebrelimab with or without platinum; Bevacizumab with or without platinum) in subjects with advanced solid tumors.

Key Dates

First listed
Mar 29, 2024
Start date
Apr 11, 2024
Status verified
Jul 2024
Primary completion
Apr 8, 2026
Completion
Apr 8, 2028

Study Design

Enrollment
1,048 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HS-20089 and Adebrelimab
  • Experimental: HS-20089, Adebrelimab and cisplatin / carboplatin
  • Experimental: HS-20089 and Bevacizumab
  • Experimental: HS-20089, Bevacizumab and cisplatin / carboplatin

Primary Outcome Measure

Maximum tolerated dose (MTD) or maximum applicable dose (MAD) of HS-20089 in combination therapy [ Time Frame: Up to day 21 from the first dose ]

Central Contacts

Related Studies