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

• Sponsor: Biotheus Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05862831
• Collaborator: (none)
• Enrollment: 285
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 50.3
• Patients Per Site: 142.5
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumors	Biological: PM1003 Injection	Phase 1/Phase 2

Detailed Description

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 285 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: In dose escalation stage, three subjects will be enrolled at the protocol starting dose of PM1032 for 21 Days DLT observation, followed by same dose every 2 weeks (Q2W) until they meet the discontinuation criteria. Dose escalation will proceed to the next dose level according to the 3+3 design. Dose expansion stage of the study will be initiated at the Sponsor's discretion at the dose level and treatment schedule which was established as the recommended Phase 2 dose (RP2D) in the dose escalation stage.In dose escalation stage, three subjects will be enrolled at the protocol starting dose of PM1032 for 21 Days DLT observation, followed by same dose every 2 weeks (Q2W) until they meet the discontinuation criteria. Dose escalation will proceed to the next dose level according to the 3+3 design. Dose expansion stage of the study will be initiated at the Sponsor's discretion at the dose level and treatment schedule which was established as the recommended Phase 2 dose (RP2D) in the dose escalation stage.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Sep 7, 2021
• Anticipated Primary Completion Date: Sep 7, 2025
• Anticipated Study Completion Date: Nov 15, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PM1003 PM1003 0.02mg/kg-10mg/kg	Biological: PM1003 Injection; Subjects will receive PM1003 by intravenous administration.

Outcome Measures

Primary Outcome Measures

1. Dose Limited Toxicity（DLT） [up to 21 days]

   Occurrence of DLT after receiving PM1003 injection

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer Hospital Affiliated to Shandong First Medical University	Jinan	Shandong	China
2	Shanghai Orient Hospital	Shanghai		China

Sponsors and Collaborators

• Biotheus Inc.

Investigators

• Principal Investigator: Ye Guo, Shanghai Orient Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biotheus Inc.
• ClinicalTrials.gov Identifier: NCT05862831
• Other Study ID Numbers: PM1003-AB001M-ST-R
• First Posted: May 17, 2023
• Last Update Posted: May 17, 2023
• Last Verified: May 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Biotheus Inc.: PD-L1, 4-1BB
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of May 17, 2023