A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With ES-SCLC

Sponsor
Biotheus Inc.
Study ID
NCT05844150
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • PM8002 — DRUG
    IV infusion
  • Platinum — DRUG
    IV infusion
  • Etoposide — DRUG
    IV infusion

Study Details

PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study to evaluate the efficacy and safety of PM8002 in combination with etoposide and platinum in first-line treatment of extensive-stage small cell lung cancer

Key Dates

First listed
May 6, 2023
Start date
Jun 1, 2023
Status verified
Mar 2025
Primary completion
May 10, 2024
Completion
Dec 31, 2025

Study Design

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

Arms

  • Experimental: PM8002+Etoposide＋platinum
    Subjects will be administered with PM8002 plus Etoposide and platinum via intravenously (IV) Q3W for 4 cycles, followed by PM8002 until progression or for a maximum of 2 years.

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: Up to approximately 2 years ]

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