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

Sponsor
Biotheus Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05879068
Collaborator
(none)
99
Enrollment
1
Location
1
Arm
47.1
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
99 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study to Evaluate Efficacy, Safety and Pharmacokinetics of PM8002 Injection in Combination With Paclitaxel Injection as Second Line Treatment for Small Cell Lung Cancer(SCLC)
Actual Study Start Date :
May 27, 2022
Anticipated Primary Completion Date :
Apr 30, 2024
Anticipated Study Completion Date :
Apr 30, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: PM8002
IV infusion

Drug: Paclitaxel
IV infusion

Outcome Measures

Primary Outcome Measures

  1. Objective Response Rate [Up 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.

  2. 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

  1. 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.

  2. 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.

  3. 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).

  4. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jilin Provincial Tumor Hospital Changchun China

Sponsors and Collaborators

  • Biotheus Inc.

Investigators

  • Principal Investigator: Ying Cheng, Jilin Provincial Tumor Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Biotheus Inc.
ClinicalTrials.gov Identifier:
NCT05879068
Other Study ID Numbers:
  • PM8002-B002C-SCLC-R
First Posted:
May 30, 2023
Last Update Posted:
May 30, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Biotheus Inc.
Second line
Additional relevant MeSH terms:
Paclitaxel

Study Results

No Results Posted as of May 30, 2023