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

Advanced Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04891653
• Other study ID #: QF-BR790-101
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 30, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2021
• Source: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: December 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• BR790
Subjects will receive oral administration of BR790.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose limiting toxicity (DLT)		up to 32 day
Primary	maximum tolerated dose (MTD)		up to 32 day
Primary	recommended phase II clinical study dose (RP2D)		up to 32 day
Secondary	AUC		up to 32 day
Secondary	Cmax		up to 32 day
Secondary	t1/2		up to 32 day
Secondary	pERK	the level of pERK in blood	up to 32 day
Secondary	AE	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	through study completion, an average of 3 years
Secondary	ORR		through study completion, an average of 3 years