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Trial Title:
Phase I/IIa Study of BR790 in Combination With Tislelizumab in Adult Subjects With Advanced Solid Tumors
NCT ID:
NCT05505877
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Tislelizumab
Conditions: Keywords:
BR790,SHP2, checkpoint inhibitor, PD-1, NSCLC, CRC, HNSCC
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BR790+Tislelizumab
Description:
BR790 will be administered orally, variable dose.
Tislelizumab will be administered as an intravenous infusion,fixed dose.
Arm group label:
BR790+Tislelizumab dose escalation
Arm group label:
BR790+Tislelizumab dose expansion
Summary:
This study is a Phase I/IIa, multi-center, open-label study of BR790 in combination with
Tislelizumab with a dose escalation part followed by a dose expansion part in adult
subjects with advanced solid tumors.
These treatment to characterize the safety, tolerability, PK, PD and preliminary
antitumor activity.
The study treatment will be administered until the subject experiences unacceptable
toxicity, progressive disease, and/or has treatment discontinued at the discretion of the
Investigator or the subject, or due to withdrawal of consent.
Detailed description:
Phase 1 (Dose Escalation Phase of BR790 Tablets Combined with Tislelizumab Injection):
According to the incidence of DLT in BR790 Tablets Combined with Tislelizumab Injection
Monoclonal Antibody in the Treatment of Advanced Solid Tumors, MTD and the Phase 2
clinical trial dose (RP2D) combining PK , efficacy and safety data were determined.
Stage II (BR790 Tablets combined with tislelizumab injection dose expansion stage):
Evaluate the objective response rate (ORR) of BR790 Tablets combined with tislelizumab
injection according to Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 .
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Sign informed consent voluntarily.
2. Age ≥18 and ≤75 years old.
3. Subjects with advanced solid tumors diagnosed by histology or cytology，whose desease
progressed after standard treatment or have no standard treatment.
4. Had at least one measurable lesion.
5. ECOG≤1.
6. Expected survival period ≥ 3 months.
Exclusion Criteria:
1. Any previous treatment with SHP-2 inhibitor.
2. Symptomatic brain metastases.
3. Subjects with thoracic/ascites fluid that need drainage or intervention.
4. Subjects with not enough organ functional reserve at baseline, which met at least
one of the following criteria： ANC<1.5×10^9/L PLT<100×10^9/L Hb<90g/L TBIL>1.5×ULN
ALT, AST>2.5×ULN (without liver metastases) or ALT, AST>5×ULN (with liver
metastases), Cr >1.5×ULN.
5. With uncontrolled severe disease.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-Sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510000
Country:
China
Status:
Recruiting
Contact:
Last name:
LI zhang
Start date:
September 10, 2022
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Shanghai Gopherwood Biotech Co., Ltd.
Agency class:
Industry
Source:
Shanghai Gopherwood Biotech Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05505877
