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

A Open-label, Multi-center Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics and Efficacy of BR790 Monotherapy in Subjects With Advanced Solid Tumors

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: BR790

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 5-65mg QD	Drug: BR790; Subjects will receive oral administration of BR790.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC		up to 32 day
Cmax		up to 32 day
t1/2		up to 32 day
pERK	the level of pERK in blood	up to 32 day
AE	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	through study completion, an average of 3 years
ORR		through study completion, an average of 3 years

Collaborators and Investigators

• Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 30, 2021
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: May 11, 2021
• First Submitted That Met QC Criteria: May 12, 2021
• First Posted (Actual): May 18, 2021

Study Record Updates

• Last Update Posted (Actual): May 18, 2021
• Last Update Submitted That Met QC Criteria: May 12, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: QF-BR790-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No