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This study is testing a new medicine, SNV4818, for people with advanced cancers. The researchers want to find out if SNV4818 is safe, well-tolerated, and effective in treating solid tumors. They are investigating different doses in order to find the safest and most effective one.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SNV4818 Monotherapy | Experimental | Participants will receive oral, daily doses of SNV4818 as a single agent as part of either dose escalation or dose expansion cohorts. The SNV4818 dose level participants receive will depend upon the study part to which they are assigned. Dose escalation participants will be assigned to small cohorts of ascending SNV4818 dose levels. Dose expansion participants will receive one of the SNV4818 dose levels recommended for further evaluation. |
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| SNV4818+Fulvestrant Combination | Experimental | Participants will receive oral, daily doses of SNV4818 in combination with a standard dose of Fulvestrant as part of either dose escalation or dose expansion cohorts.. The SNV4818 dose level participants receive will depend upon the study part to which they are assigned. Dose escalation participants will be assigned to small cohorts of ascending SNV4818 dose levels. Dose expansion participants will receive one of the SNV4818 dose levels recommended for further evaluation. |
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| SNV4818+Palbociclib+Fulvestrant Combination | Experimental | Participants will receive oral, daily doses of SNV4818 in combination with a standard doses of Palbociclib and Fulvestrant as part of either dose escalation or dose expansion cohorts.. The SNV4818 dose level participants receive will depend upon the study part to which they are assigned. Dose escalation participants will be assigned to small cohorts of ascending SNV4818 dose levels. Dose expansion participants will receive one of the SNV4818 dose levels recommended for further evaluation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SNV4818 | Drug | SNV4818 is a tablet taken orally. Dose and frequency are dependent upon treatment arm. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose limiting toxicities (DLTs) | -Number of participants experiencing protocol-defined DLTs (Part 1A and 2A only) | First 28 days of study treatment |
| Treatment Emergent Adverse Events (TEAEs) | Incidence and frequency of TEAEs | From first SNV4818 dose through approximately 30 days following the last SNV4818 dose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration of SNV4818 | Cmax | After 4 weeks (1 cycle) of study treatment |
| Time to reach the maximum observed plasma concentration of SNV4818 | Tmax |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert Casper | Contact | 443-764-9527 | rcasper@synnovationtx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate | Recruiting | Los Angeles | California | 90025 | United States |
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| ID | Term |
|---|---|
| D000077267 | Fulvestrant |
| C500026 | palbociclib |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 |
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| Fulvestrant | Drug | Fulvestrant is administered via an intramuscular injection. It will be given at a dose of 500 mg (2-250 mg/5 mL injections) |
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| Palbociclib | Drug | Palbociclib tablets will be administered by mouth on days 1-21 of a 28 day cycle. The Palbociclib starting dose will be 125 mg once-daily |
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| After 4 weeks (1 cycle) of study treatment |
| Area Under Plasma Concentration (AUC) Time Curve of SNV4818 | AUC0-t | After 4 weeks (1 cycle) of study treatment |
| Half-life of SNV4818 | t1/2 | After 4 weeks (1 cycle) of study treatment |
| Area Under Plasma Concentration (AUC) Time Curve of SNV4818 extrapolated to infinity | AUC0-infinity | After 1 day of study treatment |
| Apparent oral clearance of SNV4818 | CL/F | After 4 weeks (1 cycle) of study treatment |
| Apparent volume of distribution of SNV4818 | Vz/F | After 4 weeks (1 cycle) of study treatment |
| Overall response rate (ORR) | The proportion of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR), based on RECIST 1.1 criteria | After 8 weeks on study treatment |
| Disease control rate (DCR) | The proportion of participants who have a best overall response (BOR) of stable disease (SD) or better | After 8 weeks on study treatment |
| Duration of response (DOR) | The time interval between an assessment of partial response (PR) or better and disease progression or death due to any cause. | Up to approximately 2 years |
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
| Thomas Jefferson University-Sidney Kimmel Cancer Center | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
| Sarah Cannon Research Institute | Recruiting | Nashville | Tennessee | 37203 | United States |
| The University of Texas M.D. Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| Chris O'Brien Lifehouse | Recruiting | Camperdown | New South Wales | 2050 | Australia |
| Scientia Clinical Research | Recruiting | Randwick | New South Wales | 2031 | Australia |
| Monash Health | Recruiting | Clayton | Victoria | 3168 | Australia |
| Peter MacCallum Cancer Centre | Recruiting | Melbourne | Victoria | 3000 | Australia |
| Linear Clinical Research | Recruiting | Nedlands | Western Australia | 6009 | Australia |
| The Ottawa Hospital Cancer Centre | Recruiting | Ottawa | Ontario | K1H 8L6 | Canada |
| University Health Network, Princess Margaret Cancer Centre | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |