BR790 in Combination With Anlotinib in Adult Subjects With Advanced Non-Small Cell Lung Cancer

NCT ID: NCT05715398

Last Updated: 2023-02-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-28
• Study Completion Date: 2025-12-31

Brief Summary

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.

Detailed Description

This study is a Phase Ⅰ/Ⅱa, multi-center, open-label study of BR790 in combination with anlotinib with a dose escalation part followed by a dose expansion part in adult subjects with advanced NSCLC. Participants will be treated until disease progression per RECIST v1.1, unacceptable toxicity, or other criteria for withdrawal are met, whichever occurs first.

Conditions

Non-Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BR790+anlotinib

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

Group Type: EXPERIMENTAL

BR790+anlotinib

Intervention Type: DRUG

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

Interventions

BR790+anlotinib

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Gopherwood Biotech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Baohui Han

Role: PRINCIPAL_INVESTIGATOR

Shanghai Chest Hospital

Central Contacts

Baohui Han, professor

Role: CONTACT

18930858216@163.com

18930858216 ext. +86

Other Identifiers

BR790-103

Identifier Type: -

Identifier Source: org_study_id