A Phase I Study of BR790 in Subjects With Advanced Solid Tumors

NCT04891653 | Unknown Phase 1

• 1 other identifier: QF-BR790-101
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study was to evaluate the safety and tolerability of BR790 tablets as an oral monotherapy in subjects with advanced solid tumors, and to determine dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and/or recommended phase II clinical trial dose (RP2D) .The study is divided into two phases: dose escalation phase and dose expansion phase.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (3)

• Dose limiting toxicity (DLT)

  up to 32 day

• maximum tolerated dose (MTD)

  up to 32 day

• recommended phase II clinical study dose (RP2D)

  up to 32 day

Secondary Outcomes (6)

• AUC

  up to 32 day

• Cmax

  up to 32 day

• t1/2

  up to 32 day

• pERK

  up to 32 day

• AE

  through study completion, an average of 3 years

Study Arms (1)

5-65mg QD

EXPERIMENTAL

Drug: BR790

Interventions

BR790 DRUG

Subjects will receive oral administration of BR790.

5-65mg QD

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.

Sponsors & Collaborators

• Jiangxi Qingfeng Pharmaceutical Co. Ltd.: lead

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: May 11, 2021
• First Posted: May 18, 2021
• Study Start: June 30, 2021
• Primary Completion: June 30, 2023
• Study Completion: December 31, 2023
• Last Updated: May 18, 2021

Record last verified: 2021-05