Clinical trial · Interventional
Phase I/IIa Study of BR790 in Combination With Tislelizumab in Adult Subjects With Advanced Solid Tumors
A Multicenter, Open-Label Phase 1/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics and Efficacy of BR790 Tablets in Combination With Tislelizumab Injection in Patients With Advanced Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BR790+Tislelizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- BR790+Tislelizumab dose escalation
- description
- Dose escalation part
- interventionNames
- Drug: BR790+Tislelizumab
- type
- EXPERIMENTAL
- label
- BR790+Tislelizumab dose expansion
- description
- Dose expansion part
- interventionNames
- Drug: BR790+Tislelizumab
Primary outcomes (2)
- measure
- Dose limiting toxicity (DLT)
- timeFrame
- 24 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available