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Recruiting NCT05918445

PM8002 in the Treatment of Patients With Advanced Solid Tumors

Phase I / Phase II Interventional Malignant Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PM8002.
Who it may be relevant to
Registry conditions: Malignant Neoplasm. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug PM8002
    IV infusion

Primary outcome measures

  • Number of participants with DLTs [Time frame: During the first three weeks of treatment with PM8002]
  • Treatment related adverse events (TRAEs) [Time frame: Up to 30 days after last treatment]
  • Objective response rate (ORR) [Time frame: Up to approximately 2 years]
Secondary outcome measures (5)
  • Disease control rate (DCR) [Time frame: Up to approximately 2 years]
  • Duration of response (DoR) [Time frame: Up to approximately 2 years]
  • Overall survival (OS) [Time frame: Up to approximately 2 years]
  • Progression-free survival (PFS) [Time frame: Up to approximately 2 years]
  • Anti-drug antibody (ADA) [Time frame: Up to 30 days after last treatment]

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;
  • Other conditions lead to inappropriate to participate in this study as judged by the investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

China · 48 centers
  • Baoji Central Hospital — Baoji
  • Baoji Central Hospital — Baoji
  • Cancer Hospital Chinese Academy of Medical Sciences — Beijing
  • Peking University Cancer Hospital — Beijing
  • Peking University Cancer Hospital — Beijing
  • Jilin Cancer Hospital — Changchun
  • The First Hospital of Jilin University — Changchun
  • Changde First People's Hospital — Changde
  • … and 40 more centers

Identifiers

NCT: NCT05918445 · PM8002-A001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗