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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05862831
Recruitment Status : Recruiting
First Posted : May 17, 2023
Last Update Posted : May 17, 2023
Sponsor:
Information provided by (Responsible Party):
Biotheus Inc.

Study Description
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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
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Study Type : Interventional
Estimated 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.
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 : September 7, 2021
Estimated Primary Completion Date : September 7, 2025
Estimated Study Completion Date : November 15, 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: PM1003
PM1003 0.02mg/kg-10mg/kg
 Biological: PM1003 Injection
Subjects will receive PM1003 by intravenous administration.


Outcome Measures
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Primary Outcome Measures :
  1. Dose Limited Toxicity（DLT） [ Time Frame: up to 21 days ]
    Occurrence of DLT after receiving PM1003 injection

  2. Assess the incidence and severity of treatment-related adverse events [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05862831


Contacts
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Contact: Jie Zhang +86 18221509791 zhang.jie@biotheus.com
Contact: Ye Guo pattrickguo@gmail.com

Locations
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China, Shandong
Cancer Hospital Affiliated to Shandong First Medical University Recruiting
Jinan, Shandong, China
Contact: Yuping Sun       13370582181@163.com   
China
Shanghai Orient Hospital Recruiting
Shanghai, China
Contact: Ye Guo       pattrickguo@gmail.com   
Sponsors and Collaborators
Biotheus Inc.
Investigators
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Principal Investigator: Ye Guo Shanghai Orient Hospital
More Information
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Responsible Party: Biotheus Inc.
ClinicalTrials.gov Identifier: NCT05862831    
Other Study ID Numbers: PM1003-AB001M-ST-R
First Posted: May 17, 2023    Key Record Dates
Last Update Posted: May 17, 2023
Last Verified: May 2023

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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:
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Neoplasms