Open
Actively Recruiting
A Study of SY 5609, a Selective CDK7 Inhibitor, in Advanced Solid Tumors
About
Brief Summary
The study consists of 2 parts. Part 1 is dose escalation and will first administer SY-5609 alone to participants with select advanced solid tumors and then in combination with fulvestrant to participants with HR positive, HER2-negative breast cancer. Part 2 is a dose expansion and will first administer SY-5609 in combination with gemcitabine and then SY-5609 in combination with gemcitabine and nab-paclitaxel in participants with pancreatic ductal adenocarcinoma (PDAC) .
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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. Participants must have failed prior treatment with a cyclin-dependent kinase (CDK) 4/6 inhibitor in combination with hormonal therapy in a previous line of therapy (Group 2 only).
- Participants with histologically or cytologically confirmed PDAC with measurable metastatic lesion(s) (Groups 3 and 4 only).
- Participants must have at least 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
- Participants must be willing and able to comply with all aspects of the protocol
- Participants must provide written informed consent before any study-specific screening procedures.
- Albumin ≥ 3.0 grams/deciliters (g/dL) (Groups 3 and 4 only).
Exclusion Criteria:
- Chemotherapy or limited field radiotherapy within 2 weeks, wide field radiotherapy within 4 weeks, or nitrosoureas or mitomycin C within 6 weeks before entering the study
- Major surgery within 2 weeks before starting the study treatment, or not recovered to baseline status from the effects of surgery received > 2 weeks prior
- Received any other investigational agents within 4 weeks before enrollment, or < 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 2 weeks, or < 5 half-lives since completion of previous therapy, whichever is shorter
- Known brain metastases or carcinomatous meningitis
- Immunocompromised participants with increased risk of opportunistic infections
- Participants with known active or chronic hepatitis B or active hepatitis C infection. Participants 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 milliseconds
- NOTE: criterion does not apply to participants with a right or left bundle branch block (QTc interval)
- Female participants who are pregnant or breastfeeding
- History of clinically significant cardiac disease or clinically relevant uncontrolled cardiac risk factors
- Uncontrolled intercurrent illness.
- Poorly controlled ascites requiring paracentesis within 1 month prior to entering the study. (Groups 3 and 4 only)
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Study Stats
Protocol No.
22-000341
Category
Hematology-Oncology
Oncology
Principal Investigator
Contact
Location
- UCLA Santa Monica