NCT05918445 PM8002 in the Treatment of Patients With Advanced Solid Tumors
| NCT ID | NCT05918445 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Biotheus Inc. |
| Condition | Malignant Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 380 participants |
| Start Date | 2021-03-09 |
| Primary Completion | 2025-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 380 participants in total. It began in 2021-03-09 with a primary completion date of 2025-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of PM8002, a PD-L1/VEGF bispecific antibody, as a single agent in adult subjects with advanced solid tumors.
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. Patients with malignant tumor confirmed by histology or cytology; 4. The toxicity of previous anti-tumor therapy has not been alleviated； 5. Adequate organ function； 6. ECOG score was 0-1; 7. Expected survival \>=12 weeks; 8. According to RECIST 1.1 criteria, at least 1 measurable lesion that has not been previously treated locally. Exclusion Criteria: 1. History of severe allergic disease, severe allergy to drugs or known allergy to any component of the drug in this study; 2. Evidence of major coagulopathy or other obvious risk of bleeding; 3. Patients are experiencing a clear interstitial lung disease or non-infectious pneumonia, unless it is caused by local radiotherapy; 4. Patients with uncontrolled brain metastases should be excluded from this clinical trial; 5. Patients ever experienced other active malignant tumors within 5 years prior to the study treatment; 6. Prior allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 7. Known history of alcohol abuse, psychotropic drug abuse or drug abuse; 8. Syphilis antibody positive; 9. Patients with active tuberculosis (TB) are excluded; 10. Pregnant or lactating women; 11. Other conditions lead to inappropriate to participate in this study as judged by the investigator.
Contact & Investigator
Ye Guo
PRINCIPAL INVESTIGATOR
Shanghai Orient Hospital
Frequently Asked Questions
Who can join the NCT05918445 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Malignant Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05918445 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05918445 currently recruiting?
Yes, NCT05918445 is actively recruiting participants. Contact the research team at pattrickguo@gmail.com for enrollment information.
Where is the NCT05918445 trial being conducted?
This trial is being conducted at Baoji, China, Baoji, China, Beijing, China, Beijing, China and 11 additional locations.
Who is sponsoring the NCT05918445 clinical trial?
NCT05918445 is sponsored by Biotheus Inc.. The principal investigator is Ye Guo at Shanghai Orient Hospital. The trial plans to enroll 380 participants.