Treatment of advanced malignant solid tumors with PM1003

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

This study is testing a new treatment called PM1003 to see if it can help people with advanced solid tumors feel better and improve their health.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 285 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Biotheus Inc. (Industry-sponsored)
• Locations: 2 sites (Jinan, Shandong and 1 other locations)
• Trial ID: NCT05862831 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety, tolerability, pharmacokinetics, and preliminary efficacy of PM1003, a bispecific antibody targeting PD-L1 and 4-1BB, in patients with advanced solid tumors. It is a single-arm, open-label, multicenter study that aims to gather data on how well PM1003 works in this patient population. Participants will receive PM1003 injections and will be monitored for their response to the treatment and any side effects experienced.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with confirmed malignant tumors and adequate organ function.

Not a fit: Patients with severe allergies to macromolecular protein drugs or those with an ECOG score greater than 1 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.

How similar studies have performed: Other studies targeting PD-L1 and 4-1BB have shown promise, indicating potential for success with this approach.

Eligibility 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.

Where this trial is running

Jinan, Shandong and 1 other locations

• Cancer Hospital Affiliated to Shandong First Medical University — Jinan, Shandong, China (Recruiting)
• Shanghai Orient Hospital — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Ye Guo — Shanghai Orient Hospital
• Study coordinator: Jie Zhang

Conditions Advanced Solid Tumors; PD-L1, 4-1BB