Clinical Study of PM1003 in Phase I/IIa Treatment of Advanced Malignant Solid Tumors

Phase 1

Recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Biological: PM1003 Injection

• Registration Number: NCT05862831
• Lead Sponsor: Biotheus Inc.

Brief Summary

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.

Detailed Description

PM1003 is a Bispecific Antibody Targeting PD-L1 and 4-1BB.

Study Timeline

• Study Start: 2021-09-07
• Status Verified: 2023-05
• Study First Submitted: 2023-05-08
• Study First Submitted QC: 2023-05-08
• Last Update Submitted: 2023-05-08
• Study First Posted: 2023-05-17
• Last Update Posted: 2023-05-17
• Primary Completion: 2025-09-07
• Study Completion: 2025-11-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 285

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PM1003	PM1003 Injection	PM1003 0.02mg/kg-10mg/kg

Primary Outcome Measures

Name	Time	Method
Dose Limited Toxicity（DLT）	up to 21 days	Occurrence of DLT after receiving PM1003 injection
Assess the incidence and severity of treatment-related adverse events	Up to 30 days after last treatment	The incidence and severity of treatment-emergent adverse events (TEAEs) and treatment related adverse events (TRAEs) graded according to NCI-CTCAE v5.0

Trial Locations

Locations (2)

Cancer Hospital Affiliated to Shandong First Medical University; 🇨🇳 Jinan, Shandong, China

Shanghai Orient Hospital; 🇨🇳 Shanghai, China