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

Trial status:Unmapped
Trial ID:
PM1032-AB001M-ST-R
NCT ID:
NCT05839106
EudraCT ID:
N/A
EU Trial (CTIS) Number:
N/A
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
BioNTech SE
Collaborator:
N/A
Unmapped

Trial Details

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.

Medical Condition
Unmapped
Study Drug
PM1032 injection
Phase
Phase 1/Phase 2
Type
Interventional
Estimated Enrolment
200
Estimated Trial Date
Jul 2022 - Apr 2025

Trial Participant Requirements

Age
18 - 75 Years
Sex
Female & Male
Healthy Volunteers
No
Inclusion and Exclusion Criteria
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.

Trial Locations

Location
Status
Location
Shulan (Hang Zhou) Hospital
Hangzhou, China
Status
Recruiting
Location
The first affiliated hospital of nanchang university
Nanchang, China
Status
Recruiting
Location
Shanghai Orient Hospital
Shanghai, China
Status
Recruiting