Phase I/IIa Study of BR790 in Combination With Tislelizumab in Adult Subjects With Advanced Solid Tumors

Shanghai Gopherwood Biotech

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: BR790+Tislelizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05505877

BR790-102

Details and patient eligibility

About

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.

Full description

Phase 1 (Dose Escalation Phase of BR790 Tablets Combined with Tislelizumab Injection): According to the incidence of DLT in BR790 Tablets Combined with Tislelizumab Injection Monoclonal Antibody in the Treatment of Advanced Solid Tumors, MTD and the Phase 2 clinical trial dose (RP2D) combining PK , efficacy and safety data were determined.

Stage II (BR790 Tablets combined with tislelizumab injection dose expansion stage): Evaluate the objective response rate (ORR) of BR790 Tablets combined with tislelizumab injection according to Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 .

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Any previous treatment with SHP-2 inhibitor.
2. Symptomatic brain metastases.
3. Subjects with thoracic/ascites fluid that need drainage or intervention.
4. 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.
5. With uncontrolled severe disease.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

BR790+Tislelizumab dose escalation

Experimental group

Description:

Dose escalation part

Treatment:

Drug: BR790+Tislelizumab

BR790+Tislelizumab dose expansion

Experimental group

Description:

Dose expansion part

Treatment:

Drug: BR790+Tislelizumab