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This is a Phase 1 study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PRT7732 in patients with select advanced or metastatic solid tumors with a SMARCA4 mutation.
This is an open-label, multi-center, first-in-human, Phase 1 study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PRT7732 an oral SMARCA degrader in patients with select advanced or metastatic solid tumors with a SMARCA4 mutation. Approximately 104 participants will be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRT7732 | Experimental | PRT7732 is administered as an oral capsule once daily. Dose escalation/de-escalation decisions will be guided by the BLRM method until the RDE is determined. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRT7732 | Drug | PRT7732 capsules will be self-administered once daily at the dose-level assigned |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting toxicity (DLT) of PRT7732 | Incidence of dose limiting toxicities for patients in the dose escalation phase | Baseline through Day 21 |
| Safety and tolerability of PRT7732 as measured by incidence of DLTs | Safety and tolerability will be evaluated by incidence of DLTs | Baseline through completion of study, an average of 2 years |
| Safety and tolerability of PRT7732 as measured by incidence of laboratory deviations | Safety and tolerability will be evaluated by laboratory measurements | Baseline through study completion, an average of 2 years |
| Safety and tolerability as measured by rates of dose modification due to AEs according to NCI CTCAE | Safety and tolerability will be evaluated by dose interruption, modification, and discontinuation due to adverse events (AEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Baseline through study completion, an average of 2 years |
| Maximum tolerated dose (MTD) of PRT7732 | Maximum tolerated dose will be determined by the sponsor based on the Safety Review Committee's recommendation considering the totality of the available clinical safety, clinical efficacy, pharmacokinetics (PK), and pharmacodynamic data | Baseline through study completion, an average of 2 years |
| Recommended dose for expansion (RDE) of PRT7732 | The RDE will be determined by the sponsor based on the Safety Review Committee's recommendation considering the totality of the available clinical safety, clinical efficacy, pharmacokinetics (PK), and pharmacodynamic data |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of PRT7732 | Best overall response of either complete response (CR) or partial response (PR), as assessed by the investigator per RECIST v1.1 | Baseline through study completion, an average of 2 years |
| Pharmacokinetic profile of PRT7732 as a single agent: Maximum observed plasma concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94158 | United States | ||
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| Baseline through study completion, an average of 2 years |
Pharmacokinetics will be calculated including the maximum observed plasma concentration |
| Baseline through study completion, an average of 2 years |
| Pharmacokinetic profile of PRT7732 as a single agent: Area under the curve | Pharmacokinetics will be calculated including the area under the plasma concentration versus time curve (AUC) | Baseline through study completion, an average of 2 years |
| Pharmacokinetic profile of PRT7732 as a single agent: Time of maximum concentration (Tmax) and half-life (T1/2) | Pharmacokinetic parameters will be calculated using standard non-compartmental techniques | Baseline through study completion, an average of 2 years |
| Pharmacodynamic effects of PRT7732 as a single agent | The pharmacodynamic effect of PRT7732 demonstrating target engagement by assessment of SMARCA2 protein in peripheral blood mononuclear cells and tumor tissue as assessed by reduction in protein levels of SMARCA2 in peripheral blood mononuclear cells and/or tumor tissue | Baseline through study completion, an average of 2 years |
| Brigitte Harris Cancer Pavilion |
| Detroit |
| Michigan |
| 48202 |
| United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Memorial Sloan Kettering Cancer Center - Main Campus | New York | New York | 10065 | United States |
| UNC Hospitals, The University of North Carolina Chapel Hill | Chapel Hill | North Carolina | 27514 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| SCRI Oncology Partners | Nashville | Tennessee | 37203 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| University of Virginia Comprehensive Cancer Center | Charlottesville | Virginia | 22903 | United States |
| Border Medical Oncology Research Unit | Albury | New South Wales | 2640 | Australia |
| Southern Highlands Cancer Centre | Bowral | New South Wales | 2576 | Australia |
| Scientia Clinical Research Ltd | Randwick | New South Wales | 2031 | Australia |
| Monash Health | Clayton | Victoria | 3168 | Australia |
| Linear Clinical Research Ltd | Nedlands | Western Australia | 6009 | Australia |
| University Clinic Cologne, Clinic for Internal Medicine | Cologne | North Rhine-Westfalia | 50937 | Germany |
| Technische Universitat Dresden, Medizinlsche Fakultat Carl Gustav Carus Nationales Centrum fur Tumorerkrankungen Dresden, Early Clinical Trial Unit (NCT/UCC ECTU) | Dresden | Saxony | 01307 | Germany |
| Kindai University Hospital | Sayama | Osaka | 589-8511 | Japan |
| The Univerity of Osaka Hospital | Suita | Osaka | 565-0871 | Japan |
| National Cancer Center Hospital | Chuo Ku | Tokyo | 104-0045 | Japan |
| Cancer Institute Hospital of JFCR | Koto-ku | Tokyo | 135-8550 | Japan |
| National Cancer Center | Goyang-si | Gyeonggi-do | 10408 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Hospital Universitario Vall d'Hebron | Barcelona | 08035 | Spain |
| Start Madrid-FJD, Hospital Universitario Fundacion Jimenez Diaz-Servicio de Oncologia | Madrid | 28040 | Spain |
| Hospital Universitario HM Sanchinarro | Madrid | 28050 | Spain |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| C562730 | Adenocarcinoma Of Esophagus |
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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