MC# 21-45 - A Phase I Study of SY-5609, an Oral, Selective CDK7 Inhibitor, in Adult Patients With Select Advanced Solid Tumors
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Agent(s): SY-5609
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Disease Type(s): Pancreatic
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Phase(s): I
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Drug Classification(s): Small Molecule, Targeted Therapy
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Molecular Target(s): CDK7
Mechanism of Action
SY-5609 is a potential selective, oral CDK7 inhibitor. CDK7 inhibition has been shown to target two fundamental processes in cancer: transcription and cell cycle control.
Purpose
In this study, the sponsor and investigators want to learn:
- How much of SY-5609 can be given in combination with Gemcitabine and/or nab-Paclitaxel with an acceptable level of side effects
- The effects of SY-5609 in combination with Gemcitabine and/or nab-Paclitaxel (good and bad)
- How much of SY-5609 is absorbed into the blood and how fast it is removed
- If research tests can be used in the future to predict who will benefit from SY-5609
Inclusion Criteria
- Age ≥ 18 years
- Advanced Solid Tumors for which standard curative or palliative measures do not exist or are no longer effective (Group 1 only)
- Postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer. Patients must have failed prior treatment with a CDK 4/6 inhibitor in combination with hormonal therapy in a previous line of therapy (Group 2 only).
- Patients must have at least one (1) measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- All toxicities (except alopecia) from prior cancer treatments must have resolved to ≤ Grade 1 before enrollment
- For women of childbearing potential (WCBP): negative serum β human chorionic gonadotropin pregnancy test within 1 week before the first dose of SY 5609
- Adequate organ and marrow function
- Patients must be willing and able to comply with all aspects of the protocol
- Patients must provide written informed consent before any study-specific screening procedures
Exclusion Criteria
- Chemotherapy or limited field radiotherapy within two (2) weeks, wide field radiotherapy within four (4) weeks, or nitrosoureas or mitomycin C within six (6) weeks before entering the study
- Major surgery within two (2) weeks before starting the study treatment, or not recovered to baseline status from the effects of surgery received > two (2) weeks prior
- Received any other investigational agents within 4 weeks before enrollment, or < five (5) half-lives since completion of previous investigational therapy, whichever is shorter
- Received previous noncytotoxic, US Food and Drug Administration-approved anticancer agent within previous two (2) weeks, or < five (5) half-lives since completion of previous therapy, whichever is shorter
- Known brain metastases or carcinomatous meningitis
- Immunocompromised patients with increased risk of opportunistic infections
- Patients with known active or chronic hepatitis B or active hepatitis C infection. Patients with a history of hepatitis C virus (HCV) infection who have completed curative therapy for HCV at least 12 weeks before Screening and have a documented undetectable viral load at Screening are eligible for enrollment.
- Baseline QT interval corrected (QTc) with Fridericia's method > 480 ms
- NOTE: criterion does not apply to patients with a right or left bundle branch block (QTc interval)
- Female patients who are pregnant or breastfeeding
- History of clinically significant cardiac disease or clinically relevant uncontrolled cardiac risk factors
- Uncontrolled intercurrent illness
Location
- Dallas, TX - Mary Crowley Cancer Research - Medical City
