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Clinical Trials/NCT05918445
NCT05918445
Recruiting
Phase 1

Phase Ib/IIa Safety and Efficacy of PM8002, a Bispecific Antibody Targeting PD-L1 and VEGF-A, as a Monotherapy in Patients With Advanced Solid Tumors

Biotheus Inc.14 sites in 1 country380 target enrollmentMarch 9, 2021
InterventionsPM8002
DrugsPM8002

Overview

Phase
Phase 1
Intervention
PM8002
Conditions
Malignant Neoplasm
Sponsor
Biotheus Inc.
Enrollment
380
Locations
14
Primary Endpoint
Treatment related adverse events (TRAEs)
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 9, 2021
End Date
November 30, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Voluntary participation in clinical study; fully understand the study and sign informed consent voluntarily; willing to follow and able to complete all test procedures;
  • Male or female aged 18 to 75 years;
  • Patients with malignant tumor confirmed by histology or cytology;
  • The toxicity of previous anti-tumor therapy has not been alleviated;
  • Adequate organ function;
  • ECOG score was 0-1;
  • Expected survival \>=12 weeks;
  • According to RECIST 1.1 criteria, at least 1 measurable lesion that has not been previously treated locally.

Exclusion Criteria

  • History of severe allergic disease, severe allergy to drugs or known allergy to any component of the drug in this study;
  • Evidence of major coagulopathy or other obvious risk of bleeding;
  • Patients are experiencing a clear interstitial lung disease or non-infectious pneumonia, unless it is caused by local radiotherapy;
  • Patients with uncontrolled brain metastases should be excluded from this clinical trial;
  • Patients ever experienced other active malignant tumors within 5 years prior to the study treatment;
  • Prior allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
  • Known history of alcohol abuse, psychotropic drug abuse or drug abuse;
  • Syphilis antibody positive;
  • Patients with active tuberculosis (TB) are excluded;
  • Pregnant or lactating women;

Arms & Interventions

PM8002

PM8002 IV every 2 weeks(q2w) or every 3 weeks(q3w)

Intervention: PM8002

Outcomes

Primary Outcomes

Treatment related adverse events (TRAEs)

Time Frame: Up to 30 days after last treatment

The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0

Number of participants with DLTs

Time Frame: During the first three weeks of treatment with PM8002

DLTs will be assessed during the dose-escalation phase and are defined as toxicities that meet pre-defined severity criteria and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs within the first cycle (3weeks) of treatment.

Objective response rate (ORR)

Time Frame: Up to approximately 2 years

Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.

Secondary Outcomes

  • Anti-drug antibody (ADA)(Up to 30 days after last treatment)
  • Duration of response (DoR)(Up to approximately 2 years)
  • Overall survival (OS)(Up to approximately 2 years)
  • Progression-free survival (PFS)(Up to approximately 2 years)
  • Disease control rate (DCR)(Up to approximately 2 years)

Study Sites (14)

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