Clinical trial · Interventional
PM8002 in the Treatment of Patients With Advanced Solid Tumors
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
NCT05918445CI-TRIAL-00083360recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PM8002 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PM8002
- description
- PM8002 IV every 2 weeks(q2w) or every 3 weeks(q3w)
- interventionNames
- Drug: PM8002
Primary outcomes (3)
- measure
- Number of participants with DLTs
- timeFrame
- During the first three weeks of treatment with PM8002
- description
- 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.
- measure
- Treatment related adverse events (TRAEs)
- timeFrame
- Up to 30 days after last treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.