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Phase I/IIa Study for PM1032 in the Treatment of Patients With Advanced Solid Tumors

Sponsor
Biotheus Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05839106
Collaborator
(none)
200
Enrollment
3
Locations
1
Arm
41.8
Anticipated Duration (Months)
66.7
Patients Per Site
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study is being conducted to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of PM1032 for patients with advanced tumors, also to explore the recommended Phase Ⅱ Dose（RP2D） of PM1032.

Condition or Disease Intervention/Treatment Phase
  • Drug: PM1032 injection
 Phase 1/Phase 2

Detailed Description

PM1032 is a Bispecific Antibody Targeting CLDN18.2 and 4-1BB.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Sequential 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:
A Phase I/IIa Study to Evaluate the Tolerance, Safety, Pharmacokinetic Characteristics and Preliminary Efficacy of PM1032 in Patients With Advanced Solid Tumors
Actual Study Start Date :
Jul 8, 2022
Anticipated Primary Completion Date :
Apr 10, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: PM1032 monotherapy

PM1032 0.3mg/kg-12mg/kg

Drug: PM1032 injection
Subjects will receive PM1032 by intravenous administration.
Other Names:
  • PM1032

    		•

    Outcome Measures

    Primary Outcome Measures

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

      Occurrence of DLT after receiving PM1032 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:

    • Voluntary participation in clinical study; fully understand the study and sign informed consent voluntarily;

    • Male or female aged 18 to 75 years;

    • Subjects with malignant tumor confirmed by histology or cytology, subjects with advanced malignant solid tumors who have no standard treatment, have failed standard treatment or are not eligible for standard treatment:

    1. Phase I dose escalation stage: gastric/gastroesophageal junction adenocarcinoma, esophageal cancer, etc.;

    2. Phase I dose expansion stage, phase IIa dose expansion stage: gastric/gastroesophageal junction adenocarcinoma, esophageal cancer, other tumors; CLDN18.2-positive tumor expression as determined by the CLDN18.2 IHC assay in central laboratory.

    • Adequate organ function;

    • ECOG score was 0-1;

    • Expected survival≥12 weeks;

    Exclusion Criteria:

    • History of severe allergic, severe allergy to drugs or known allergy to any component of the drug in this study;

    • Previous exposure to immune co-stimulatory molecule agonists such as 4-1BB mono/bispecific antibodies, etc;

    • Patients who received CLDN18.2-targeted mono/bispecific antibodies or cell therapy;

    • Cerebral parenchymal metastasis or meningeal metastasis with clinical symptoms were deemed unsuitable for this study by the investigator;

    • Current definite interstitial lung disease or non-infectious pneumonitis, except for local radiotherapy;

    • Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;

    • Adverse reactions to previous anti-tumor therapy have not recovered to NCI-CTCAE V5.0 rating≤1;

    • Patients ever received the following treatments or drugs prior to the study treatment:

    1. Major organ surgery within 28 days prior to initiation of trial treatment or requiring elective surgery during the trial period;

    2. Received live attenuated vaccine within 28 days prior to the study treatment;

    3. Received chemotherapy, radical/extensive radiation, biotherapy, endocrine therapy and other anti-tumor drug therapy within 4 weeks of the first administration;

    4. Received systemic glucocorticoid or other immunosuppressive therapy within 2 weeks before the trial treatment;

    • Active bleeding within 3 months of the first administration;

    • History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation;

    • Pregnant or lactating women;

    • Other conditions considered unsuitable for this study by the investigator.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shulan (Hang Zhou) Hospital Hangzhou China
    2 The first affiliated hospital of nanchang university Nanchang China
    3 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:
    NCT05839106
    Other Study ID Numbers:
    • PM1032-AB001M-ST-R
    First Posted:
    May 3, 2023
    Last Update Posted:
    May 6, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Biotheus Inc.
    CLDN 18.2
    4-1BB

    Study Results

    No Results Posted as of May 6, 2023