Phase I/II Clinical Study to Evaluate VB15010 Tablets in Patients with Advanced Solid Tumors

Shenzhen Yangli Pharmaceutical Technology

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Breast Cancer; Ovarian Neoplasms; Neoplasms, Breast; Biliary Cancer; Neoplasms; PARP; Tumor; Cancer; Prostatic Cancer; Colorectal Cancer; Pancreatic Cancer

Treatments: Drug: VB15010

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06819215

VB15010-001

Details and patient eligibility

About

This research is designed to determine if experimental treatment with PARP1 inhibitor, VB15010 is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumors.

Enrollment: 188 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 at the time of screening;
• Histological or cytological confirmation of advanced malignancy ;
• Progressive cancer at the time of study entry;
• Adequate organ and marrow function as defined by the protocol;
• Homologous recombination repair gene mutation.

Exclusion criteria

• Major surgery within 4 weeks of the first dose of study treatment.
• Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring continuous corticosteroids at a dose of >10mg prednisone/day or equivalent for at least 4 weeks prior to start of study treatment. Patients with leptomeningeal carcinomatosis are excluded.
• Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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188 participants in 1 patient group

Experimental

Experimental group

Description:

VB15010 Monotherapy

Treatment:

Drug: VB15010