Clinical trial · Interventional
Clinical Study of PM1003 in Phase I/IIa Treatment of Advanced Malignant Solid Tumors
Phase I Study to Evaluate the Tolerability, Safety, Pharmacokinetic and Primary Efficacy of PM1003 in Patients With Advanced Solid Tumors and Phase IIa Study to Evaluate the Primary Efficacy of PM1003 in Advanced Solid Tumors
NCT05862831CI-TRIAL-00066492unknownPhase 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 is a single-arm, open-lable, multicenter phase I/IIa clinical trial evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of PM1003 in the treatment of 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 |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PM1003 Injection | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PM1003
- description
- PM1003 0.02mg/kg-10mg/kg
- interventionNames
- Biological: PM1003 Injection
Primary outcomes (2)
- measure
- Dose Limited Toxicity(DLT)
- timeFrame
- up to 21 days
- description
- Occurrence of DLT after receiving PM1003 injection
- measure
- Assess the incidence and severity of treatment-related adverse events
- timeFrame
- Up to 30 days after last treatment
- description
- The incidence and severity of treatment-emergent adverse events (TEAEs) and treatment related adverse events (TRAEs) graded according to NCI-CTCAE v5.0
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. Subjects with malignant tumor confirmed by histology or cytology; 4. Adequate organ function; 5. ECOG score was 0-1. 6. Pre-menopausal female subjects with negative blood pregnancy results within 7 days prior to the study treatment, and agree to abstain from sex or use medically approved effective contraceptive measures for 6 months from the date of signing the informed consent form to the end of the last medication; 7. Male subjects are agree to abstain from sex or use medically approved effective contraceptive methods for 6 months from the date of signing the informed consent form to the end of the last medication, and do not donate sperm during this period. Exclusion Criteria: 1. History of severe allergic to macromolecular protein drugs, severe allergy to drugs or known allergy to any component of the drug in this study; 2. Treatment with any 4-1BB monoclonal antibody or 4-1BB-containing dual antibody immune co-stimulatory molecule agonist; 3. Current active infection requiring intravenous anti-infective therapy; 4. Current presence of uncontrolled pleural, pericardial, and peritoneal effusions; 5. Known history of alcohol abuse, psychotropic drug abuse or drug abuse; 6. History of neurological or psychiatric disorders, such as epilepsy, dementia, schizophrenia, etc.; 7. Anticipated need for any other form of antineoplastic drug treatment during the trial; 8. Women who are pregnant or breastfeeding; 9. 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.