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PM8002 in the Treatment of Patients With Advanced Solid Tumors

Sponsor
Biotheus Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05918445
Collaborator
(none)
380
Enrollment
1
Location
1
Arm
44.7
Anticipated Duration (Months)
8.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of PM8002, a PD-L1/VEGF bispecific antibody, as a single agent in adult subjects with advanced solid tumors.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
380 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase Ib/IIa Safety and Efficacy of PM8002, a Bispecific Antibody Targeting PD-L1 and VEGF-A, as a Monotherapy in Patients With Advanced Solid Tumors
Actual Study Start Date :
Mar 9, 2021
Anticipated Primary Completion Date :
Nov 30, 2023
Anticipated Study Completion Date :
Nov 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: PM8002

PM8002 IV every 2 weeks(q2w) or every 3 weeks(q3w)

Drug: PM8002
IV infusion

Outcome Measures

Primary Outcome Measures

  1. Number of participants with DLTs [During the first three weeks of treatment with PM8002]

    DLTs will be assessed during the dose-escalation phase and are defined as toxicities that meet pre-defined severity criteria and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs within the first cycle (3weeks) of treatment.

  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

  3. Objective response rate (ORR) [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.

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). for subjects with no documented disease progression, the deadline is the data of the last examination.

  3. 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.

  4. Progression-free survival (PFS) [Up to approximately 2 years]

    Progression-free survival is defined as the time from the start of treatment with PM8002 until the first documentation of disease progression or death due to any cause, whichever occurs first.

  5. Anti-drug antibody (ADA) [Up to 30 days after last treatment]

    To evaluate the incidence of ADA to PM8002.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Voluntary participation in clinical study; fully understand the study and sign informed consent voluntarily; willing to follow and able to complete all test procedures;

  2. Male or female aged 18 to 75 years;

  3. Patients with malignant tumor confirmed by histology or cytology;

  4. The toxicity of previous anti-tumor therapy has not been alleviated；

  5. Adequate organ function；

  6. ECOG score was 0-1;

  7. Expected survival >=12 weeks;

  8. According to RECIST 1.1 criteria, at least 1 measurable lesion that has not been previously treated locally.

Exclusion Criteria:

  1. History of severe allergic disease, severe allergy to drugs or known allergy to any component of the drug in this study;

  2. Evidence of major coagulopathy or other obvious risk of bleeding;

  3. Patients are experiencing a clear interstitial lung disease or non-infectious pneumonia, unless it is caused by local radiotherapy;

  4. Patients with uncontrolled brain metastases should be excluded from this clinical trial;

  5. Patients ever experienced other active malignant tumors within 5 years prior to the study treatment;

  6. Prior allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;

  7. Known history of alcohol abuse, psychotropic drug abuse or drug abuse;

  8. Syphilis antibody positive;

  9. Patients with active tuberculosis (TB) are excluded;

  10. Pregnant or lactating women;

  11. Other conditions lead to inappropriate to participate in this study as judged by the investigator.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shanghai Orient Hospital Shanghai Shanghai China

Sponsors and Collaborators

  • Biotheus Inc.

Investigators

  • Principal Investigator: YE GUO, Shanghai Orient Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Biotheus Inc.
ClinicalTrials.gov Identifier:
NCT05918445
Other Study ID Numbers:
  • PM8002-A001
First Posted:
Jun 26, 2023
Last Update Posted:
Jun 27, 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
Additional relevant MeSH terms:
Neoplasms

Study Results

No Results Posted as of Jun 27, 2023