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

Advanced Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05862831
• Other study ID #: PM1003-AB001M-ST-R
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: September 7, 2021
• Est. completion date: November 15, 2025

Study information

• Verified date: May 2023
• Source: Biotheus Inc.
• Contact: Jie Zhang
• Phone: +86 18221509791
• Email: zhang.jie[@]biotheus.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 285
• Est. completion date: November 15, 2025
• Est. primary completion date: September 7, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

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. 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.

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Biological:
• PM1003 Injection
Subjects will receive PM1003 by intravenous administration.

Locations

Country	Name	City	State
China	Cancer Hospital Affiliated to Shandong First Medical University	Jinan	Shandong
China	Shanghai Orient Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Biotheus Inc.

Country where clinical trial is conducted

China, 

Outcome

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