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Trial Title:
Clinical Study of PM1003 in Phase I/IIa Treatment of Advanced Malignant Solid Tumors
NCT ID:
NCT05862831
Condition:
Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
PD-L1, 4-1BB
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
In dose escalation stage, three subjects will be enrolled at the protocol starting dose
of PM1032 for 21 Days DLT observation, followed by same dose every 2 weeks (Q2W) until
they meet the discontinuation criteria.
Dose escalation will proceed to the next dose level according to the 3+3 design.
Dose expansion stage of the study will be initiated at the Sponsor's discretion at the
dose level and treatment schedule which was established as the recommended Phase 2 dose
(RP2D) in the dose escalation stage.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
PM1003 Injection
Description:
Subjects will receive PM1003 by intravenous administration.
Arm group label:
PM1003
Summary:
This is a single-arm, open-lable, multicenter phase I/IIa clinical trial evaluating the
safety, tolerability, pharmacokinetics, and preliminary efficacy of PM1003 in the
treatment of advanced solid tumors.
Detailed description:
PM1003 is a Bispecific Antibody Targeting PD-L1 and 4-1BB.
Criteria for eligibility:
Criteria:
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. Subjects with malignant tumor confirmed by histology or cytology;
4. Adequate organ function;
5. ECOG score was 0-1.
6. Pre-menopausal female subjects with negative blood pregnancy results within 7 days
prior to the study treatment, and agree to abstain from sex or use medically
approved effective contraceptive measures for 6 months from the date of signing the
informed consent form to the end of the last medication;
7. Male subjects are agree to abstain from sex or use medically approved effective
contraceptive methods for 6 months from the date of signing the informed consent
form to the end of the last medication, and do not donate sperm during this period.
Exclusion Criteria:
1. History of severe allergic to macromolecular protein drugs, severe allergy to drugs
or known allergy to any component of the drug in this study;
2. Treatment with any 4-1BB monoclonal antibody or 4-1BB-containing dual antibody
immune co-stimulatory molecule agonist;
3. Current active infection requiring intravenous anti-infective therapy;
4. Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;
5. Known history of alcohol abuse, psychotropic drug abuse or drug abuse;
6. History of neurological or psychiatric disorders, such as epilepsy, dementia,
schizophrenia, etc.;
7. Anticipated need for any other form of antineoplastic drug treatment during the
trial;
8. Women who are pregnant or breastfeeding;
9. Other conditions lead to inappropriate to participate in this study as judged by the
investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital Affiliated to Shandong First Medical University
Address:
City:
Jinan
Country:
China
Status:
Recruiting
Contact:
Last name:
Yuping Sun
Email:
13370582181@163.com
Facility:
Name:
Shanghai Orient Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Ye Guo
Email:
pattrickguo@gmail.com
Start date:
September 7, 2021
Completion date:
November 15, 2025
Lead sponsor:
Agency:
Biotheus Inc.
Agency class:
Industry
Source:
Biotheus Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05862831
