Clinical trial · Interventional
BR790 in Combination With Anlotinib in Adult Subjects With Advanced Non-Small Cell Lung Cancer
A Multicenter, Open Phase Ⅰ/Ⅱa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BR790 in Combination With Anlotinib in Subjects With Advanced Non-small Cell Lung Cancer
NCT05715398CI-TRIAL-00063840unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 is a Phase Ⅰ/Ⅱa, multi-center, open-label study, aiming to evaluate the safety, tolerability, pharmacokinetic (PK), and efficacy of BR790 in combination with anlotinib in adult participants with advanced NSCLC.
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 |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BR790+anlotinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BR790+anlotinib
- description
- BR790 will be administered orally, variable dose on Day 1 of each 21-day cycle, Anlotinib will be administered as PO fixed dose on Day1-14 of each 21-day cycle
- interventionNames
- Drug: BR790+anlotinib
Primary outcomes (2)
- measure
- Maximum tolerated dose/Recommended Phase Ⅱ Dose(MTD/RP2D)
- timeFrame
- 2 years
- description
- To evaluate the MTD/RP2D of BR790 in combination with anlotinib (Part 1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- 2 years
- description
- To evaluate the objective response rate (ORR) of BR790 in combination with anlotinib. ORR is defined as the proportion of subjects who achieve a Complete Response (CR) or Partial Response (PR) as assessed by RECIST v1.1 (Part 2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 and ≤75 years old. * Subjects with histologically or cytologically confirmed locally advanced or relapsed metastatic driver negative (EGFR, ALK, ROS, etc.) advanced NSCLC,whose disease progressed after at least 2 previous standard therapies. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. * Has at least one measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) . Exclusion Criteria: * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. * Has uncontrolled moderate to massive effusion. * Central lung squamous carcinoma along with cavum, or non-small cell lung cancer along with hemoptysis (\>50ml/day). * Other kinds of malignancies within 5 years or for now. * Has 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\<100g/L; TBIL\>1.5×ULN, ALT or AST\>2.5×ULN (without liver metastases) , ALT or AST\>5×ULN (with liver metastases);Cr \>1.5×ULN, urine protein≥++,or confirmed 24h urine protein≥1.0g;INR \>1.5×ULN, PT\>1.5ULN or APTT \>1.5×ULN. * Previous use of other SHP2 inhibitors (such as TNO-155, JAB-3312, JAB-3068, RLY-1971, RMC-4630, etc.) * Has used anlotinib before * The first assessment of efficacy was PD, or occurred ≥grade 3 adverse reactions with antitumor angiogenesis small-molecule drugs (e.g. Apatinib, surufatinib, fruquintinib, etc.), or less than 6 months after the last antitumor vascular therapy. * Has got non remissive toxic reactions derived from previous therapies, which is over level 1 in CTC AE (5.0), alopecia and grade 2 peripheral neuropathy are not included.
References
Publications (0)
Data not yet available
No reference posted for this study.