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

Phase 2
Active, not recruiting
Conditions
SCLC
Interventions
Drug: PM8002
Drug: Paclitaxel
Registration Number
NCT05879068
Lead Sponsor
Biotheus Inc.
Brief Summary

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.

Detailed 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

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
99
Inclusion Criteria
  1. Signed informed consent form before any trial-related processes;
  2. Age β‰₯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 β‰₯12 weeks;
  8. Had at least one measurable tumor lesion according to RECIST v1.1.
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
PM8002+PaclitaxelPM8002Subjects 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.
PM8002+PaclitaxelPaclitaxelSubjects 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.
Primary Outcome Measures
NameTimeMethod
Objective Response RateUp to approximately 2 years

Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.

Treatment related adverse events (TRAEs)Up to 30 days after last treatment

The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0

Secondary Outcome Measures
NameTimeMethod
Overall survival (OS)Up to approximately 2 years

OS is the time from the date of first dosing date to death due to any cause.

Disease control rate (DCR)Up to approximately 2 years

DCR is defined as the proportion of subjects with CR, PR, or stable disease(SD) based on RECIST v1.1.

Duration of response (DoR)Up to approximately 2 years

DoR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST v1.1) or death due to any cause, whichever occurs first.

Progression free survival (PFS)Up to approximately 2 years

PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST v1.1).

Trial Locations

Locations (11)

Peking University Cancer Hospital

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Beijing, China

Hunan Cancer Hospital

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Changsha, China

Sichuan Provincial People's Hospital

πŸ‡¨πŸ‡³

Chengdu, China

Zhejiang Provincial People's Hospital

πŸ‡¨πŸ‡³

Hangzhou, China

Harbin Medical University Cancer Hospital

πŸ‡¨πŸ‡³

Harbin, China

Shandong Cancer Hospital

πŸ‡¨πŸ‡³

Jinan, China

The First Affiliated Hospital of Nanchang University

πŸ‡¨πŸ‡³

Nanchang, China

Shanghai Pulmonary Hospital

πŸ‡¨πŸ‡³

Shanghai, China

The First Affiliated Hospital of Xi'an Jiaotong University

πŸ‡¨πŸ‡³

Xi'an, China

Henan Cancer Hospital

πŸ‡¨πŸ‡³

Zhengzhou, China

Jilin Provincial Tumor Hospital

πŸ‡¨πŸ‡³

Changchun, China

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