Treatment of advanced solid tumors with PM1032

A Phase I/IIa Study to Evaluate the Tolerance, Safety, Pharmacokinetic Characteristics and Preliminary Efficacy of PM1032 in Patients With Advanced Solid Tumors

This study is testing a new treatment called PM1032 for people with advanced solid tumors to see if it is safe and effective in slowing down tumor growth.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Biotheus Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 3 sites (Hangzhou and 2 other locations)
• Trial ID: NCT05839106 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, pharmacokinetics, and preliminary efficacy of PM1032, a bispecific antibody targeting CLDN18.2 and 4-1BB, in patients with advanced solid tumors. It includes a Phase I dose escalation stage for patients with gastric or gastroesophageal junction adenocarcinoma and a Phase IIa dose expansion stage for additional tumor types. The study aims to determine the recommended Phase II dose of PM1032 while assessing its effects on tumor progression.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with advanced CLDN18.2-positive solid tumors who have failed or are ineligible for standard treatments.

Not a fit: Patients with severe allergies to the study drug or its components, or those with certain prior immune therapy exposures may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that currently have limited treatment options.

How similar studies have performed: Other studies targeting similar pathways have shown promise, suggesting potential for success in this novel approach.

Eligibility 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.

Where this trial is running

Hangzhou and 2 other locations

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

Study contacts

• Principal investigator: Ye Guo — Shanghai Orient Hospital
• Study coordinator: Xiying Dong

Conditions Advanced Tumor; CLDN 18.2; 4-1BB