A Study of BPI-452080 in Subjects With Solid Tumors

Betta Pharmaceuticals

Status and phase: Not yet enrolling; Phase 1

Conditions: Solid Tumor; Von Hippel-Lindau Disease; Renal Cell Carcinoma

Treatments: Drug: BPI-452080

Study type: Interventional

Funder types: Industry

Identifiers

NCT05843305

BTP-661811

Details and patient eligibility

About

This open-label Phase 1 study will evaluate the efficacy and safety of BPI-452080 in patients with Solid Tumors

Enrollment: 87 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically confirmed locally advanced or metastatic solid tumor patients, who had disease progression after standard therapy, intolerable to standard therapy, refuse to standard therapy or for whom no standard therapy exists
• Dose expansion phase:

Arm1：has locally advanced or metastatic ccRCC and has progressed during treatment with at least one prior therapeutic regimen Arm2：Von Hippel-Lindau Disease-Associated Clear Cell Renal Cell Carcinoma Arm3：Other solid tumors

• Adequate organ function
• Evaluable lesion required for dose escalation phase and at least 1 measurable lesion required for dose expansion phase

Exclusion criteria

• Has received prior treatment with another HIF-2α inhibitor
• Inadequate wash-out of prior therapies described per protocol, which may include anti-tumor therapies, tumor adjuvant drugs, organ or stem cell transplantation, moderate or strong CYP3A inhibitor or inducer, etc
• Patients with major surgery within 4 weeks, severe or unstable systemic disease, unstable/symptomatic CNS metastasis, other malignant tumors, ILD, clinical significant cardiac disease, bleeding or embolic disease, active infectious disease, or other medical or psychiatric condition that might interfere with participation in the trial or interfere with the interpretation of trial results, in the opinion of the investigator or medical monitor
• Pregnancy or lactation

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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87 participants in 2 patient groups

Dose Escalation

Experimental group

Description:

Oral tablets taken in escalating levels to determine MTD/RP2D. Each treatment cycle will be 21 days in duration with BPI-452080 administered once daily.

Treatment:

Drug: BPI-452080

Dose Expansion

Experimental group

Description:

Oral tablets administered at MTD/RP2D defined dose. Each treatment cycle will be 21 days in duration with BPI-452080 administered once daily. Cohort 1: Locally Advanced or Metastatic ccRCC Cohort 2: VHL disease associated RCC Cohort 3: Other Advanced Solid Tumors

Treatment:

Drug: BPI-452080