A Study of PM8002 Injection in Combination With Standard Chemotherapy as First Line Therapy in MPM

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

A Study of PM8002 Injection in Combination With Standard Chemotherapy as First Line Therapy in MPM (NCT05918107) is a Phase 2 interventional studying MPM, sponsored by Biotheus Inc.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study will evaluate the efficacy and safety of PM8002 in combination with pemetrexed and platinum as first line treatment for MPM.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against MPM and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 55 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused MPM subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Voluntarily participate in clinical research; fully understand the study and voluntarily sign the willing to sign a consent form; 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). Who Should NOT Join This Trial: 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); ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

PM8002

IV infusion

DRUG

Pemetrexed

IV infusion

DRUG

Cisplatin

IV infusion

DRUG

Carboplatin

IV infusion

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Jilin Provincial Tumor Hospital

Changchun, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05918107), the sponsor (Biotheus Inc.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05918107 clinical trial studying?

PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study will evaluate the efficacy and safety of PM8002 in combination with pemetrexed and platinum as first line treatment for MPM. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05918107?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05918107?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05918107. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05918107. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.