PM8002 in the Treatment of Patients With Advanced Solid Tumors

Biotheus

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Malignant Neoplasm

Treatments: Drug: PM8002

Study type: Interventional

Funder types: Industry

Identifiers

NCT05918445

PM8002-A001

Details and patient eligibility

About

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.

Enrollment: 380 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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380 participants in 1 patient group

PM8002

Experimental group

Description:

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

Treatment:

Drug: PM8002