PM8002 in the Treatment of Patients With Advanced Solid Tumors

Sponsor
Biotheus Inc.
Study ID
NCT05918445
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Malignant Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This study is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of PM8002, a PD-L1/VEGF bispecific antibody, as a single agent in adult subjects with advanced solid tumors.

Key Dates

Start date
Mar 9, 2021
Status verified
Nov 2024
Primary completion
Nov 30, 2025
Completion
Nov 30, 2025

Study Design

Enrollment
380 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: PM8002
    PM8002 IV every 2 weeks(q2w) or every 3 weeks(q3w)

Primary Outcome Measure

Number of participants with DLTs [ Time Frame: During the first three weeks of treatment with PM8002 ]

Central Contacts

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