A Study of PM8002 Injection in Combination With Standard Chemotherapy as First Line Therapy in MPM

Sponsor
Biotheus Inc.
Study ID
NCT05918107
Phase
PHASE2
Status
Completed

Conditions

  • MPM

Eligibility Criteria

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

Interventions

  • PM8002 — DRUG
    IV infusion
  • Pemetrexed — DRUG
    IV infusion
  • Cisplatin — DRUG
    IV infusion
  • Carboplatin — DRUG
    IV infusion

Study Details

PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study will evaluate the efficacy and safety of PM8002 in combination with pemetrexed and platinum as first line treatment for MPM.

Key Dates

Start date
Aug 13, 2022
Status verified
Jun 2026
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
31 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: PM8002+pemetrexed+platinum
    Subjects will be administered with PM8002 plus pemetrexed+platinum via intravenously (IV) Q3W for 4-6 cycles,followed by PM8002 until disease progression intolerable toxicity for a maximum of 2 years.

Primary Outcome Measure

Objective Response Rate [ Time Frame: : Up to approximately 2 years ]