A Study of PM8002 in Combination With Chemotherapy in Patients With SCLC

Biotheus

Status and phase: Active, not recruiting; Phase 2

Conditions: SCLC

Treatments: Drug: PM8002; Drug: Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT05879068

PM8002-B002C-SCLC-R

Details and patient eligibility

About

PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study will evaluate the efficacy and safety of PM8002 in combination with paclitaxel as second line treatment for SCLC.

Full description

This is a phase II, single arm study assessing the efficacy and safety of PM8002 in combination with paclitaxel as second line treatment for SCLC who failed first-line platinum-based chemotherapy with or without checkpoint inhibitors therapy

Enrollment: 99 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed informed consent form before any trial-related processes;
2. Age ≥18 years;
3. Histologically or cytologically confirmed SCLC;
4. Advanced SCLC who failed first-line platinum-based chemotherapy with or without checkpoint inhibitors;
5. Have adequate organ function;
6. The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;
7. Life expectancy of ≥12 weeks;
8. Had at least one measurable tumor lesion according to RECIST v1.1.

Exclusion criteria

1. History of severe allergic disease, severe drug allergy or have known allergy to any component of the study drugs;
2. Evidence and history of severe bleeding tendency;
3. History of severe cardiovascular diseases within 6 months;
4. Current presence of severe superior vena cava syndrome and spinal cord compression;
5. Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;
6. History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation;
7. History of alcohol abuse, psychotropic substance abuse or drug abuse;
8. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome;
9. Pregnant or lactating women;
10. Other conditions considered unsuitable for this study by the investigator.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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99 participants in 1 patient group

PM8002+Paclitaxel

Experimental group

Description:

Subjects will be administered with PM8002 plus Paclitaxel via intravenously (IV) Q3W for 5 cycles, followed by PM8002 until disease progression or intolerable toxicity for a maximum of 2 years.

Treatment:

Drug: Paclitaxel

Drug: PM8002