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SAR260301 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part A Monotherapy | EXPERIMENTAL | Dose escalation of daily or twice daily SAR260301 within a 28-day cycle, followed by an expansion phase at the maximal tolerated dose |
| Part B Combination | EXPERIMENTAL | Dose escalation of twice-daily SAR260301 within a 28-day cycle and in combination with 720 or 960 mg twice daily of Vemurafenib, followed by an expansion phase at the maximal tolerated dose of SAR260301 in combination |
| Name | Type | Description |
|---|---|---|
| SAR260301 | DRUG | Pharmaceutical form: film-coated tablets Route of administration: oral |
| Vemurafenib | DRUG | Pharmaceutical form: film-coated tablets Route of administration: oral |
Inclusion criteria : * Age ≥18 years old * Locally advanced or metastatic solid tumor disease as well as lymphoma for which no alternative therapy is available (Part A) * Unresectable / metastatic BRAF-mutated melanomas, progressing on BRAF inhibitor after no more than 4 months treatment or with on...
SAR260301 is an investigational small molecule developed by Sanofi for the treatment of malignant neoplasms, or advanced solid tumors. It is a PIK3CB inhibitor and was studied in a Phase 1/Ib clinical trial, both as monotherapy and in combination with vemurafenib, in patients with various advanced cancers.
SAR260301 targets PIK3CB, also known as phosphoinositide 3-kinase beta. It is classified as an inhibitor of this target. The compound is a small molecule designed to inhibit PIK3CB activity in cancer cells. The Phase 1/Ib trial of SAR260301 used a biomarker-selected patient population.
SAR260301 is developed by Sanofi, which trades on the New York Stock Exchange under the ticker SNY. Sanofi sponsored the Phase 1/Ib clinical trial of SAR260301 in patients with advanced cancer. The drug is an oncology asset in Sanofi's pipeline.
SAR260301 is in Phase 1 development. It is an investigational drug and is not approved by the FDA. One Phase 1/Ib trial has been completed, and no active trials are currently listed. The completed trial enrolled 75 patients across the United States and Canada.
SAR260301 was evaluated in the completed Phase 1/Ib trial NCT01673737, titled a Phase I/Ib Trial for the Evaluation of SAR260301 in Monotherapy or in Combination With Vemurafenib in Patients With Various Advanced Cancer. The trial enrolled 75 patients aged 18 years and older and was conducted in the United States and Canada.
SAR260301 was studied for the treatment of malignant neoplasms, specifically various advanced cancers. The Phase 1/Ib trial NCT01673737 evaluated SAR260301 as monotherapy and in combination with vemurafenib in patients with advanced cancer. It remains an investigational agent and is not approved for any indication.