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

NCT05862831 | Unknown Phase 1

• 1 other identifier: PM1003-AB001M-ST-R
• Study Type: interventional
• Target: 285
• Locations: 1 country
• Sites: 2

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.

Conditions

Advanced Solid Tumors

Keywords

PD-L1, 4-1BB

Outcome Measures

Primary Outcomes (2)

• Dose Limited Toxicity（DLT）

  Occurrence of DLT after receiving PM1003 injection

  up to 21 days

• 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

Study Arms (1)

PM1003

EXPERIMENTAL

PM1003 0.02mg/kg-10mg/kg

Biological: PM1003 Injection

Interventions

PM1003 Injection BIOLOGICAL

Subjects will receive PM1003 by intravenous administration.

PM1003

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary participation in clinical study; fully understand the study and sign informed consent voluntarily; willing to follow and able to complete all test procedures;
• Male or female aged 18 to 75 years;
• Subjects with malignant tumor confirmed by histology or cytology;
• Adequate organ function;
• ECOG score was 0-1.
• 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;
• 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.

You may not qualify if:

• History of severe allergic to macromolecular protein drugs, severe allergy to drugs or known allergy to any component of the drug in this study;
• Treatment with any 4-1BB monoclonal antibody or 4-1BB-containing dual antibody immune co-stimulatory molecule agonist;
• Current active infection requiring intravenous anti-infective therapy;
• Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;
• Known history of alcohol abuse, psychotropic drug abuse or drug abuse;
• History of neurological or psychiatric disorders, such as epilepsy, dementia, schizophrenia, etc.;
• Anticipated need for any other form of antineoplastic drug treatment during the trial;
• Women who are pregnant or breastfeeding;
• Other conditions lead to inappropriate to participate in this study as judged by the investigator.

Sponsors & Collaborators

• Biotheus Inc.: lead

Study Sites (2)

Cancer Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, China

RECRUITING

Shanghai Orient Hospital

Shanghai, China

RECRUITING

Study Officials

• Ye Guo

  Shanghai Orient Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Zhang

CONTACT

+86 18221509791; zhang.jie@biotheus.com

Ye Guo

CONTACT

pattrickguo@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 17, 2023
• Study Start: September 7, 2021
• Primary Completion: September 7, 2025
• Study Completion: November 15, 2025
• Last Updated: May 17, 2023

Record last verified: 2023-05

Locations

CN (2)