PM8002 in the Treatment of Patients With Advanced Solid Tumors

Malignant Neoplasm Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05918445
• Other study ID #: PM8002-A001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 9, 2021
• Est. completion date: November 30, 2024

Study information

• Verified date: May 2023
• Source: Biotheus Inc.
• Contact: YE GUO
• Phone: 135 0167 8472
• Email: pattrickguo[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 380
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms

Intervention

Drug:
• PM8002
IV infusion

Locations

Country	Name	City	State
China	Shanghai Orient Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Biotheus Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with DLTs	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
Primary	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
Primary	Objective response rate (ORR)	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	Disease control rate (DCR)	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
Secondary	Duration of response (DoR)	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
Secondary	Overall survival (OS)	OS is the time from the date of first dosing date to death due to any cause.	Up to approximately 2 years
Secondary	Progression-free survival (PFS)	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
Secondary	Anti-drug antibody (ADA)	To evaluate the incidence of ADA to PM8002.	Up to 30 days after last treatment