RecruitingPhase 2

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

China55 participantsStarted 2022-08-13

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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;
✓. Male or female, aged ≥18 years;
✓. Malignant mesothelioma confirmed by histology, without indication for surgery;
✓. 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);
✓. Sufficient organ function;
✓. Eastern Cooperative Oncology Group (ECOG) physical status (PS) score is 0-1;
✓. Expected survival period ≥ 12 weeks;
✓. 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

✕. 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;
✕. Brain parenchymal metastases or meningeal metastases with clinical symptoms, judged by the investigators as not suitable for inclusion;
✕. 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);
✕. Currently there are uncontrollable pleural, pericardial, and peritoneal effusions, and those with catheter drainage also need to be excluded;
✕. Unexplained fever \> 38.5°C before starting the study treatment (judged by the investigator, fever caused by tumor can be included in the group);
✕. 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;
✕. Currently have clear interstitial lung disease or non-infectious pneumonia, except radiation pneumonitis caused by local radiotherapy;
✕. There are active infections;

What they're measuring

Objective Response Rate

Timeframe: : Up to approximately 2 years

Treatment related adverse events (TRAEs)

Timeframe: Up to 30 days after last treatment]

Trial details

NCT IDNCT05918107

SponsorBiotheus Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06-30

Contact for this trial

Linlin Fan

+86 18612186005 fan.ll@biotheus.com

View on ClinicalTrials.gov More MPM trials