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Trial Title:
Phase I/IIa Study for PM1032 in the Treatment of Patients With Advanced Solid Tumors
NCT ID:
NCT05839106
Condition:
Advanced Tumor
Conditions: Keywords:
CLDN 18.2
4-1BB
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential 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:
Drug
Intervention name:
PM1032 injection
Description:
Subjects will receive PM1032 by intravenous administration.
Arm group label:
PM1032 monotherapy
Other name:
PM1032
Summary:
The study is being conducted to evaluate safety, tolerability, pharmacokinetics and
preliminary efficacy of PM1032 for patients with advanced tumors, also to explore the
recommended Phase Ⅱ Dose（RP2D） of PM1032.
Detailed description:
PM1032 is a Bispecific Antibody Targeting CLDN18.2 and 4-1BB.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Voluntary participation in clinical study; fully understand the study and sign
informed consent voluntarily;
- Male or female aged 18 to 75 years;
- Subjects with malignant tumor confirmed by histology or cytology, subjects with
advanced malignant solid tumors who have no standard treatment, have failed standard
treatment or are not eligible for standard treatment:
1. Phase I dose escalation stage: gastric/gastroesophageal junction
adenocarcinoma, esophageal cancer, etc.;
2. Phase I dose expansion stage, phase IIa dose expansion stage:
gastric/gastroesophageal junction adenocarcinoma, esophageal cancer, other
tumors; CLDN18.2-positive tumor expression as determined by the CLDN18.2 IHC
assay in central laboratory.
- Adequate organ function;
- ECOG score was 0-1;
- Expected survival≥12 weeks;
Exclusion Criteria:
- History of severe allergic, severe allergy to drugs or known allergy to any
component of the drug in this study;
- Previous exposure to immune co-stimulatory molecule agonists such as 4-1BB
mono/bispecific antibodies, etc;
- Patients who received CLDN18.2-targeted mono/bispecific antibodies or cell therapy;
- Cerebral parenchymal metastasis or meningeal metastasis with clinical symptoms were
deemed unsuitable for this study by the investigator;
- Current definite interstitial lung disease or non-infectious pneumonitis, except for
local radiotherapy;
- Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;
- Adverse reactions to previous anti-tumor therapy have not recovered to NCI-CTCAE
V5.0 rating≤1;
- Patients ever received the following treatments or drugs prior to the study
treatment:
1. Major organ surgery within 28 days prior to initiation of trial treatment or
requiring elective surgery during the trial period;
2. Received live attenuated vaccine within 28 days prior to the study treatment;
3. Received chemotherapy, radical/extensive radiation, biotherapy, endocrine
therapy and other anti-tumor drug therapy within 4 weeks of the first
administration;
4. Received systemic glucocorticoid or other immunosuppressive therapy within 2
weeks before the trial treatment;
- Active bleeding within 3 months of the first administration;
- History of allogeneic hematopoietic stem cell transplantation or allogeneic organ
transplantation;
- Pregnant or lactating women;
- Other conditions considered unsuitable for this study by the investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shulan (Hang Zhou) Hospital
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Lihua Wu
Email:
lihuawu73@163.com
Facility:
Name:
The first affiliated hospital of nanchang university
Address:
City:
Nanchang
Country:
China
Status:
Recruiting
Contact:
Last name:
Yong Li
Email:
liyongcsco@qq.com
Facility:
Name:
Shanghai Orient Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Ye Guo
Email:
pattrickguo@gmail.com
Start date:
July 8, 2022
Completion date:
December 31, 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/NCT05839106
