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PM8002 in the Treatment of Patients With Advanced Solid Tumors

PM8002 in the Treatment of Patients With Advanced Solid Tumors

Recruiting
18-75 years
All
Phase 1/2

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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.

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Study details
    Malignant Neoplasm

NCT05918445

Biotheus Inc.

26 January 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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