A Study of PM8002 in Combination With Chemotherapy in Patients With SCLC

Sponsor
Biotheus Inc.
Study ID
NCT05879068
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
  • Paclitaxel — 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 paclitaxel as second line treatment for SCLC.

Key Dates

Start date
May 27, 2022
Status verified
Dec 2024
Primary completion
Apr 30, 2025
Completion
Apr 30, 2026

Study Design

Enrollment
99 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: PM8002+Paclitaxel
    Subjects will be administered with PM8002 plus Paclitaxel via intravenously (IV) Q3W for 5 cycles, followed by PM8002 until disease progression or intolerable toxicity for a maximum of 2 years.

Primary Outcome Measure

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

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