NCT05505877

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2022

Typical duration for phase_1

Geographic Reach
1 country

1 active site

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

August 15, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 18, 2022

Completed
23 days until next milestone

Study Start

First participant enrolled

September 10, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

August 18, 2022

Status Verified

August 1, 2022

Enrollment Period

2.1 years

First QC Date

August 15, 2022

Last Update Submit

August 16, 2022

Conditions

Advanced Solid Tumor

Keywords

BR790,SHP2, checkpoint inhibitor, PD-1, NSCLC, CRC, HNSCC

Outcome Measures

Primary Outcomes (2)

  • Dose limiting toxicity (DLT)

    Incidence of dose limiting toxicities (DLTs) in the dose escalation phase. A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first treatment cycle. (Dose escalation phase)

    24 months

  • maximum tolerated dose (MTD)

    Measurements of MTD (i.e. the highest dose of BR790 associated with the occurrence of Dose Limiting Toxicities (DLTs) in \<33% of patients)

    24 months

Secondary Outcomes (7)

  • Area under the plasma concentration-time curve (AUC)

    24 months

  • Plasma concentration (Cmax)

    24 months

  • t1/2

    24 months

  • Duration of response ( DCR )

    24 months

  • Duration of response ( DOR )

    24 months

  • +2 more secondary outcomes

Study Arms (2)

BR790+Tislelizumab dose escalation

EXPERIMENTAL

Dose escalation part

Drug: BR790+Tislelizumab

BR790+Tislelizumab dose expansion

EXPERIMENTAL

Dose expansion part

Drug: BR790+Tislelizumab

Interventions

BR790+TislelizumabDRUG

BR790 will be administered orally, variable dose. Tislelizumab will be administered as an intravenous infusion,fixed dose.

BR790+Tislelizumab dose escalationBR790+Tislelizumab dose expansion

Eligibility Criteria

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

You may qualify if:

  • Sign informed consent voluntarily.
  • Age ≥18 and ≤75 years old.
  • Subjects with advanced solid tumors diagnosed by histology or cytology，whose desease progressed after standard treatment or have no standard treatment.
  • Had at least one measurable lesion.
  • ECOG≤1.
  • Expected survival period ≥ 3 months.

You may not qualify if:

  • Any previous treatment with SHP-2 inhibitor.
  • Symptomatic brain metastases.
  • Subjects with thoracic/ascites fluid that need drainage or intervention.
  • 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.
  • With uncontrolled severe disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangzhou, 510000, China

RECRUITING

MeSH Terms

Conditions

Parkinson Disease 4, Autosomal Dominant Lewy BodyCarcinoma, Non-Small-Cell LungSquamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeHead and Neck Neoplasms

Study Officials

  • li zhang

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

xiao Chen

CONTACT

010-84682600chenxiao@gfmbiotech.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2022

First Posted

August 18, 2022

Study Start

September 10, 2022

Primary Completion

October 31, 2024

Study Completion

December 31, 2024

Last Updated

August 18, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)