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

NCT ID: NCT05879068

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-27

Study Completion Date

2026-04-30

Brief Summary

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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

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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

Conditions

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SCLC

Keywords

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Second line

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PM8002+Paclitaxel

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.

Group Type EXPERIMENTAL

PM8002

Intervention Type DRUG

IV infusion

Paclitaxel

Intervention Type DRUG

IV infusion

Interventions

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PM8002

IV infusion

Intervention Type DRUG

Paclitaxel

IV infusion

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biotheus Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ying Cheng

Role: PRINCIPAL_INVESTIGATOR

Jilin Provincial Tumor Hospital

Locations

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Peking University Cancer Hospital

Beijing, , China

Site Status

Jilin Provincial Tumor Hospital

Changchun, , China

Site Status

Hunan Cancer Hospital

Changsha, , China

Site Status

Sichuan Provincial People's Hospital

Chengdu, , China

Site Status

Zhejiang Provincial People's Hospital

Hangzhou, , China

Site Status

Harbin Medical University Cancer Hospital

Harbin, , China

Site Status

Shandong Cancer Hospital

Jinan, , China

Site Status

The First Affiliated Hospital of Nanchang University

Nanchang, , China

Site Status

Shanghai Pulmonary Hospital

Shanghai, , China

Site Status

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, , China

Site Status

Henan Cancer Hospital

Zhengzhou, , China

Site Status

Countries

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China

Other Identifiers

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PM8002-B002C-SCLC-R

Identifier Type: -

Identifier Source: org_study_id