PM8002 in the Treatment of Patients With Advanced Solid Tumors

December 3, 2024 updated by: Biotheus Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

380

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Baoji, China
        • Recruiting
        • Baoji Central Hospital
        • Principal Investigator:
          • Gang Wang
        • Contact:
          • Gang Wang
      • Beijing, China
        • Recruiting
        • Peking University Cancer Hospital
        • Principal Investigator:
          • Lin Shen
        • Contact:
          • Lin Shen
      • Beijing, China
        • Recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Contact:
          • Lingying WU
        • Principal Investigator:
          • Lingying Wu
      • Changchun, China
        • Recruiting
        • Jilin Cancer Hospital
        • Principal Investigator:
          • Ying Cheng
        • Contact:
          • Yng Cheng
      • Changchun, China
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:
          • Jiuwei Cui
        • Principal Investigator:
          • Jiuwei Cui
      • Changde, China
        • Recruiting
        • Changde First People's Hospital
        • Contact:
          • Tao Wu
        • Principal Investigator:
          • Tao Wu
      • Changsha, China
        • Recruiting
        • Hunan Provincial People's Hospital
        • Contact:
          • Huaxin Duan
        • Principal Investigator:
          • Huaxin Duan
      • Changzhou, China
        • Recruiting
        • The First People's Hospital of Changzhou
        • Principal Investigator:
          • Mei Ji
        • Contact:
          • Mei Ji
      • Chengdu, China
        • Recruiting
        • Sichuan Cancer Hospital
        • Contact:
          • Yongdong Jin
        • Principal Investigator:
          • Yongdong Jin
      • Chengdu, China
        • Recruiting
        • Chengdu Integrated TCM& Western Medicine Hospital
        • Contact:
          • Ping Li
        • Principal Investigator:
          • Ping Li
      • Chongqing, China
        • Recruiting
        • Chongqing Cancer Hospital
        • Principal Investigator:
          • Hong Luo
        • Contact:
          • Hong Luo
      • Chongqing, China
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
          • Chengyou Du
        • Principal Investigator:
          • Chengyou Du
      • Chongqing, China
        • Recruiting
        • The Southwest Hospital of Amu
        • Contact:
          • Zhiqing Liang
        • Principal Investigator:
          • Zhiqing Liang
      • Fuzhou, China
        • Recruiting
        • Fujian Cancer Hospital
        • Principal Investigator:
          • Yu Chen
        • Contact:
          • Yu Chen
      • Hangzhou, China
        • Recruiting
        • Zhejiang Provincial People's Hospital
        • Contact:
          • Zhiquan Qin
        • Principal Investigator:
          • Zhiquan Qin
      • Harbin, China
        • Recruiting
        • Harbin Medical University Cancer Hospital
        • Contact:
          • Baogang Liu
        • Principal Investigator:
          • Baogang Liu
      • Hefei, China
        • Recruiting
        • Anhui Provincial Hospital
        • Principal Investigator:
          • Yueyin Pan
        • Contact:
          • Yueyin Pan
      • Linyi, China
        • Recruiting
        • Linyi Cancer Hospital
        • Principal Investigator:
          • Zhen Wang
        • Contact:
          • Jingfen Wang
      • Nanjing, China
        • Recruiting
        • Jiangsu Province Hospital
        • Principal Investigator:
          • Zengjun Wang
        • Contact:
          • Zengjun Wang
      • Shanghai, China
        • Recruiting
        • Shanghai Sixth People's Hospital
        • Contact:
          • Hun Zhao
        • Principal Investigator:
          • Hun Zhao
      • Shanghai, China
        • Recruiting
        • Shanghai Orient Hospital
        • Contact:
        • Principal Investigator:
          • Ye Guo
      • Shengjing, China
        • Recruiting
        • Shengjing Hospital of China Medical University
        • Principal Investigator:
          • Bin Wu
        • Contact:
          • Bin Wu
      • Shenyang, China
        • Recruiting
        • Liaoning Cancer Hospital
        • Contact:
          • Chunyan Wang
        • Principal Investigator:
          • Chunyan Wang
      • Shenyang, China
        • Recruiting
        • The First Hospital of China Medical University
        • Contact:
          • Funan Liu
        • Principal Investigator:
          • Funan Liu
      • Shenyang, China
        • Recruiting
        • The People's Hospital of Liaoning Province
        • Contact:
          • Lijie He
        • Principal Investigator:
          • Lijie He
      • Shijiazhuang, China
        • Recruiting
        • The Fourth Hospital of Hebei Medical University
        • Principal Investigator:
          • Da Jiang
        • Contact:
          • Da Jiang
      • Taiyuan, China
        • Recruiting
        • Shanxi Bethune Hospital
        • Contact:
          • Huijing Feng
        • Principal Investigator:
          • Huijing Feng
      • Taiyuan, China
        • Recruiting
        • Shanxi Provincial Cancer Hospital
        • Principal Investigator:
          • Shuqing Wei
        • Contact:
          • Shuqing Wei
      • Taizhou, China
        • Recruiting
        • Taizhou Hospital of Zhejiang Province
        • Contact:
          • Dongqing Lv
        • Principal Investigator:
          • Dongqing LV
      • Tianjin, China
        • Recruiting
        • The Second Hospital of Tianjin Medical University
        • Contact:
          • Gang Li
        • Principal Investigator:
          • Gang Li
      • Wuhan, China
        • Recruiting
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
        • Contact:
          • Guiling Li
        • Principal Investigator:
          • Guiling Li
      • Wuhan, China
        • Recruiting
        • Hubei Cancer Hospital
        • Principal Investigator:
          • Yi Huang
        • Contact:
          • Yi Huang
      • Xi'an, China
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
          • Ruifang An
        • Principal Investigator:
          • Ruifang An
      • Xi'an, China
        • Recruiting
        • Xi 'an International Medical Center Hospital
        • Contact:
          • Kejun Nan
        • Principal Investigator:
          • Kejun Nan
      • Yantai, China
        • Recruiting
        • Yantai Yuhuangding Hospital
        • Principal Investigator:
          • Jitao Wu
        • Contact:
          • Jitao Wu
      • Yibin, China
        • Recruiting
        • Yibin Second People's Hospital
        • Contact:
          • Kaijian Lei
        • Principal Investigator:
          • Kaijian Lei
      • Zhengzhou, China
        • Recruiting
        • Henan Cancer Hospital
        • Principal Investigator:
          • Suxia Luo
        • Contact:
          • Suxia Luo
      • Zhengzhou, China
        • Recruiting
        • The first affilated hospital of zhengzhou university
        • Contact:
          • Xingya Li
        • Principal Investigator:
          • Xingya Li
      • Zhujiang, China
        • Recruiting
        • ZhuJiang Hospital of Southern Medical University
        • Principal Investigator:
          • Jian Zhang
        • Contact:
          • Jian Zhang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PM8002
PM8002 IV every 2 weeks(q2w) or every 3 weeks(q3w)
Drug: PM8002
IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment related adverse events (TRAEs)
Time Frame: Up to 30 days after last treatment
The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0
Up to 30 days after last treatment
Number of participants with DLTs
Time Frame: 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.
During the first three weeks of treatment with PM8002
Objective response rate (ORR)
Time Frame: 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.
Up to approximately 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease control rate (DCR)
Time Frame: 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.
Up to approximately 2 years
Anti-drug antibody (ADA)
Time Frame: Up to 30 days after last treatment
To evaluate the incidence of ADA to PM8002.
Up to 30 days after last treatment
Overall survival (OS)
Time Frame: Up to approximately 2 years
OS is the time from the date of first dosing date to death due to any cause.
Up to approximately 2 years
Duration of response (DoR)
Time Frame: 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.
Up to approximately 2 years
Progression-free survival (PFS)
Time Frame: 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.
Up to approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotheus Inc.

Investigators

  • Principal Investigator: Ye Guo, Shanghai Orient Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2021

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

May 30, 2023

First Submitted That Met QC Criteria

June 15, 2023

First Posted (Actual)

June 26, 2023

Study Record Updates

Last Update Posted (Estimated)

December 5, 2024

Last Update Submitted That Met QC Criteria

December 3, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PM8002-A001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be published or presented for publications (poster, abstract, articles or papers) or any presentations.

IPD Sharing Time Frame

After the trial completed

IPD Sharing Access Criteria

NCI is committed to sharing data in accordance with NIH policy.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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