PM8002 injection combined with standard chemotherapy for malignant pleural mesothelioma

Phase II Clinical Trial to Evaluate the Preliminary Efficacy, Safety and Pharmacokinetic Characteristics of PM8002 Injection Combined With Standard Chemotherapy in the First-line Treatment of Subjects With Inoperable Malignant Mesothelioma

This study is testing if a new injection called PM8002, when combined with standard chemotherapy, can help people with advanced malignant pleural mesothelioma feel better and improve their treatment results.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Biotheus Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Changchun)
• Trial ID: NCT05918107 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of PM8002, a bispecific antibody targeting PD-L1 and VEGF, in combination with standard chemotherapy agents pemetrexed and platinum for patients with unresectable malignant pleural mesothelioma (MPM). The trial aims to determine how well this combination works as a first-line treatment. Participants will receive the treatment and be monitored for outcomes related to tumor response and safety. The study is designed to provide insights into the potential benefits of this novel therapeutic approach.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with confirmed malignant pleural mesothelioma who have not received prior systemic anti-tumor therapy.

Not a fit: Patients with a history of severe allergic reactions or those requiring surgery for their condition may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with malignant pleural mesothelioma by enhancing the effectiveness of standard chemotherapy.

How similar studies have performed: Other studies have shown promising results with similar bispecific antibody approaches, indicating potential for success in this novel application.

Eligibility criteria

Inclusion Criteria:

1. Voluntarily participate in clinical research; fully understand the study and voluntarily sign the informed consent; willing to follow and have the ability to complete all trial procedures;
2. Male or female, aged ≥18 years;
3. Malignant mesothelioma confirmed by histology, without indication for surgery;
4. Have not received systemic anti-tumor therapy in the past (if the subject has received neoadjuvant or adjuvant chemotherapy in the past, the last treatment time must be more than 6 months from the time of recurrence);
5. Sufficient organ function;
6. Eastern Cooperative Oncology Group (ECOG) physical status (PS) score is 0-1;
7. Expected survival period ≥ 12 weeks;
8. There is at least one measurable lesion (malignant pleural mesothelioma is based on mRECIST version 1.1, and malignant mesothelioma in other parts is based on RECIST version 1.1).

Exclusion Criteria:

1. History of severe allergic diseases, severe drug (including unmarked test drug) allergy history, or known allergy to any component of the drug in this study;
2. Brain parenchymal metastases or meningeal metastases with clinical symptoms, judged by the investigators as not suitable for inclusion;
3. Had other active malignant tumors within 5 years before starting the study drug treatment, except for malignant tumors that can be treated locally and cured (such as skin basal cell or squamous cell carcinoma, superficial or non-invasive bladder cancer), cervical carcinoma in situ, breast ductal carcinoma in situ, papillary thyroid carcinoma);
4. Currently there are uncontrollable pleural, pericardial, and peritoneal effusions, and those with catheter drainage also need to be excluded;
5. Unexplained fever \> 38.5°C before starting the study treatment (judged by the investigator, fever caused by tumor can be included in the group);
6. There is uncontrollable tumor-related pain, and those who need analgesic treatment should have a stable analgesic treatment plan at the time of screening; asymptomatic metastatic lesions, if they grow further, may cause dysfunction or intractable pain (such as current and spinal cord compression unrelated epidural metastases), local therapy should be considered before screening if appropriate;
7. Currently have clear interstitial lung disease or non-infectious pneumonia, except radiation pneumonitis caused by local radiotherapy;
8. There are active infections;
9. Have a history of immunodeficiency, including a positive test for human immunodeficiency virus (HIV) antibodies;
10. Positive for syphilis antibody;
11. Expect to receive any other forms of anti-tumor drug treatment during the trial period;
12. Those who have received allogeneic hematopoietic stem cell transplantation or organ transplantation in the past;
13. Pregnant or lactating women;
14. According to the investigator's judgment, the subject's basic condition may increase the risk of receiving the study drug treatment, or cause confusion for the explanation of the toxic reaction and AE;
15. Other investigators think that they are not suitable to participate in this trial.

Where this trial is running

Changchun

• Jilin Provincial Tumor Hospital — Changchun, China (Recruiting)

Study contacts

• Principal investigator: Ying Cheng — Jilin Provice Cancer Hospital
• Study coordinator: Linlin Fan

Conditions MPM; First line