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SY-5609 · 1 trial · 4 indications
| Arm | Type | Description |
|---|---|---|
| Group 1: Single Agent Dose Escalation | EXPERIMENTAL | Dose escalation phase to explore maximum tolerated dose of SY-5609 given as a single agent. |
| Group 2: SY-5609 + Fulvestrant | EXPERIMENTAL | Participants with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2) negative advanced or metastatic breast cancer (BC) that has progressed following prior treatment with a cyclin-dependent kinase (CDK)4/6 inhibitor in combination with hormonal therapy will receive SY-5609 in combination with fulvestrant. |
| Group 3: SY-5609 + Gemcitabine | EXPERIMENTAL | Participants with PDAC will receive SY-5609 in combination with gemcitabine in Safety Lead-in to identify a recommended combination dose for the expansion. The expansion part will assess the safety, tolerability, and preliminary clinical activity of SY-5609 in combination with gemcitabine at the recommended combination dose. |
| Group 4: SY-5609 + Gemcitabine + Nab-paclitaxel | EXPERIMENTAL | Participants with PDAC will receive SY-5609 in combination with gemcitabine plus nab-paclitaxel in Safety Lead-in to identify a recommended combination dose for the expansion. The expansion part will assess the safety, tolerability, and preliminary clinical activity of SY-5609 in combination with gemcitabine plus nab-paclitaxel at the recommended combination dose. |
| Name | Type | Description |
|---|---|---|
| SY-5609 | DRUG | An oral CDK7 Inhibitor |
| Fulvestrant | DRUG | Estrogen receptor antagonist |
| Gemcitabine | DRUG | Nucleoside metabolic inhibitor |
| Nab-paclitaxel | DRUG | Taxane-type chemotherapy |
Inclusion Criteria: 1. Age ≥ 18 years 2. Advanced Solid Tumors for which standard curative or palliative measures do not exist or are no longer effective (Group 1 only). 3. Postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer. Participants must have failed prior...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
SY-5609 is an investigational small molecule being studied for the treatment of advanced solid tumors, including breast cancer, small-cell lung cancer, and pancreatic cancer. It is being developed by Syros Pharmaceuticals, Inc. and has completed a Phase 1 clinical trial in patients with advanced solid tumors.
SY-5609 targets CDK7, a kinase involved in cell cycle regulation and transcription. By inhibiting CDK7, SY-5609 may interfere with cancer cell proliferation and survival. This targeted approach is being evaluated in advanced solid tumors.
SY-5609 is being developed by Syros Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol SYRS. The company focuses on developing treatments for cancer and other diseases.
SY-5609 has completed a Phase 1 clinical trial. It is an investigational drug and has not been approved by the FDA. The trial, NCT04247126, enrolled 105 patients with advanced solid tumors.
SY-5609 was evaluated in a Phase 1 clinical trial, NCT04247126, titled "A Study of SY 5609, a Selective CDK7 Inhibitor, in Advanced Solid Tumors." The trial was completed and enrolled 105 patients across sites in the United States.