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

NCT05879068 | Active Not Recruiting Phase 2

• 1 other identifier: PM8002-B002C-SCLC-R
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 11

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.

Conditions

SCLC

Keywords

Second line

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate

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

  Up to approximately 2 years

• Treatment related adverse events (TRAEs)

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

  Up to 30 days after last treatment

Secondary Outcomes (4)

• Disease control rate (DCR)

  Up to approximately 2 years

• Duration of response (DoR)

  Up to approximately 2 years

• Progression free survival (PFS)

  Up to approximately 2 years

• Overall survival (OS)

  Up to approximately 2 years

Study Arms (1)

PM8002+Paclitaxel

EXPERIMENTAL

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.

Drug: PM8002; Drug: Paclitaxel

Interventions

PM8002 DRUG

IV infusion

PM8002+Paclitaxel

Paclitaxel DRUG

IV infusion

PM8002+Paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Biotheus Inc.: lead

Study Sites (11)

Peking University Cancer Hospital

Beijing, China

Location

Jilin Provincial Tumor Hospital

Changchun, China

Location

Hunan Cancer Hospital

Changsha, China

Location

Sichuan Provincial People's Hospital

Chengdu, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, China

Location

Harbin Medical University Cancer Hospital

Harbin, China

Location

Shandong Cancer Hospital

Jinan, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, China

Location

Shanghai Pulmonary Hospital

Shanghai, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

Location

Henan Cancer Hospital

Zhengzhou, China

Location

MeSH Terms

Interventions

Paclitaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Ying Cheng

  Jilin Provincial Tumor Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: May 30, 2023
• Study Start: May 27, 2022
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2026
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: After the trial completed.
• Access Criteria: NCI is committed to sharing data in accordance with NIH policy.

Locations

CN (11)