MC# 21-45 - A Phase I Study of SY-5609, an Oral, Selective CDK7 Inhibitor, in Adult Patients With Select Advanced Solid Tumors

  • Agent(s): SY-5609
  • Disease Type(s): Pancreatic
  • Phase(s): I
  • Drug Classification(s): Small Molecule, Targeted Therapy
  • 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
  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.  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).
  4. Patients must have at least one (1) measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  5. All toxicities (except alopecia) from prior cancer treatments must have resolved to ≤ Grade 1 before enrollment
  6. For women of childbearing potential (WCBP): negative serum β human chorionic gonadotropin pregnancy test within 1 week before the first dose of SY 5609
  7. Adequate organ and marrow function
  8. Patients must be willing and able to comply with all aspects of the protocol
  9. Patients must provide written informed consent before any study-specific screening procedures
Exclusion Criteria
  1. 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
  2. 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
  3. Received any other investigational agents within 4 weeks before enrollment, or < five (5) half-lives since completion of previous investigational therapy, whichever is shorter
  4. 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
  5. Known brain metastases or carcinomatous meningitis
  6. Immunocompromised patients with increased risk of opportunistic infections
  7. 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.
  8. 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)
  9. Female patients who are pregnant or breastfeeding
  10. History of clinically significant cardiac disease or clinically relevant uncontrolled cardiac risk factors
  11. Uncontrolled intercurrent illness

Location

  • Dallas, TX - Mary Crowley Cancer Research - Medical City
More Info: https://clinicaltrials.gov/ct2/show/NCT04247126

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Re: MC# 21-45