A Study of SY 5609 a Selective CDK7 Inhibitor in Advanced Solid Tumors

STATUS

Recruiting
participants needed

80
sponsor

Syros Pharmaceuticals

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Updated on 19 February 2024

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cancer

breast cancer

screening procedures

measurable disease

solid tumour

solid tumor

hormone therapy

endocrine therapy

metastatic breast cancer

human chorionic gonadotropin

alopecia

gonadotropin

fulvestrant

stage iv breast cancer

her2-negative breast cancer

her2/neu-negative breast cancer

health screening

hair thinning

HER2

Summary

This is a dose escalation study and will be the first to administer SY-5609 alone to humans with select advanced solid tumors and in combination with Fulvestrant to patients with HR positive, HER2-negative breast cancer.

Details

Condition	Breast Cancer, Breast Cancer, Advanced Solid Tumor
Age	18-100 years
Treatment	Fulvestrant, SY-5609
Clinical Study Identifier	NCT04247126
Sponsor	Syros Pharmaceuticals
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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 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

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A Study of SY 5609 a Selective CDK7 Inhibitor in Advanced Solid Tumors