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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Biological: PM1003 Injection

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 285
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Ye Guo; Email: pattrickguo@gmail.com
• Study Contact Backup: Name: Jie Zhang; Phone Number: +86 18221509791; Email: zhang.jie@biotheus.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Shanghai Orient Hospital
    • Contact: Ye Guo; Email: pattrickguo@gmail.com
  • Shandong
    • Jinan, Shandong, China
      • Recruiting
      • Cancer Hospital Affiliated to Shandong First Medical University
      • Contact: Yuping Sun; Email: 13370582181@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Dose Limited Toxicity（DLT）	Occurrence of DLT after receiving PM1003 injection	up to 21 days

Collaborators and Investigators

• Sponsor: Biotheus Inc.
• Investigators: Principal Investigator: Ye Guo, Shanghai Orient Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2021
• Primary Completion (Anticipated): September 7, 2025
• Study Completion (Anticipated): November 15, 2025

Study Registration Dates

• First Submitted: May 8, 2023
• First Submitted That Met QC Criteria: May 8, 2023
• First Posted (Actual): May 17, 2023

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: PD-L1, 4-1BB
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: PM1003-AB001M-ST-R

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No