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A Study of PM8002 Injection in Combination With Chemotherapy in Patients With NEN

Sponsor
Biotheus Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05879055
Collaborator
(none)
60
Enrollment
1
Location
1
Arm
55.5
Anticipated Duration (Months)
1.1
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 FOLFIRI as second line treatment for neuroendocrine neoplasm (NEC and Ki-67≥55% G3 NET).

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 FOLFIRI as second line treatment for neuroendocrine neoplasm (NEC and Ki-67≥55% G3 NET) who failed first-line platinum-based chemotherapy

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PM8002 Injection in Combination With Chemotherapy as Second Line Therapy in Unresectable Neuroendocrine Neoplasm
Actual Study Start Date :
May 17, 2023
Anticipated Primary Completion Date :
Jan 1, 2027
Anticipated Study Completion Date :
Jan 1, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: PM8002+FOLFIRI

Subjects will be administered with PM8002 plus FOLFIRI via intravenously (IV) Q2W until disease progression or intolerable toxicity for a maximum of 2 years.

Drug: PM8002
IV infusion

Drug: FOLFIRI
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. Aged ≥ 18 years;

  3. Ki-67≥55% G3 NET and NEC were confirmed histologically or cytologically by pathological diagnosis in this study;

  4. Subjects failed first-line platinum-based chemotherapy;

  5. Adequate organ function;

  6. The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;

  7. Expected survival ≥ 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. Subjects should provide formalin-fixed-paraffin-embedded (FFPE) tumor samples during the screening period (up to 24 months);

  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 Chinese PLA General Hospital Beijing China

Sponsors and Collaborators

  • Biotheus Inc.

Investigators

  • Principal Investigator: Jianming Xu, Chinese PLA General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Biotheus Inc.
ClinicalTrials.gov Identifier:
NCT05879055
Other Study ID Numbers:
  • PM8002-B009C-NEN-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
NEC
G3 NET
Additional relevant MeSH terms:
Neoplasms
Neuroendocrine Tumors

Study Results

No Results Posted as of May 30, 2023