NCT05715398

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_1 nonsmall-cell-lung-cancer

Timeline
Completed

Started Feb 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2023

Completed
20 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

February 10, 2023

Status Verified

January 1, 2023

Enrollment Period

1.8 years

First QC Date

January 12, 2023

Last Update Submit

February 8, 2023

Conditions

Non-Small Cell Lung Cancer

Keywords

BR790AnlotinibNSCLCPTPN11SHP2

Outcome Measures

Primary Outcomes (2)

  • Maximum tolerated dose/Recommended Phase Ⅱ Dose(MTD/RP2D)

    To evaluate the MTD/RP2D of BR790 in combination with anlotinib (Part 1)

    2 years

  • Objective Response Rate (ORR)

    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)

    2 years

Secondary Outcomes (7)

  • Progression-Free Survival (PFS)

    2 years

  • Duration of overall response (DOR)

    2 years

  • Disease Control Rate(DCR)

    2 years

  • Overall Survival (OS)

    2 years

  • Adverse Events(AEs)

    2 years

  • +2 more secondary outcomes

Study Arms (1)

BR790+anlotinib

EXPERIMENTAL

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

Drug: BR790+anlotinib

Interventions

BR790+anlotinibDRUG

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

BR790+anlotinib

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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) .

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungNoonan Syndrome

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesMusculoskeletal DiseasesHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Baohui Han

    Shanghai Chest Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Baohui Han, professor

CONTACT

1893085821618930858216@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2023

First Posted

February 8, 2023

Study Start

February 1, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2025

Last Updated

February 10, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share