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This is a phase 1/1b, open-label, multicenter study consisting of sequential parts designed to evaluate the safety, tolerability, and effects pharmacokinetic (PK) profile, and antitumor activity of RGT-490, an investigational oral therapy, in adults with locally advanced or metastatic solid tumors including breast cancer.
Participants enrolled in the study have advanced disease that is not amendable to curative treatment and whose tumors harbor alterations in the PI3KCA gene.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 Dose Escalation (Advanced Solid Tumors with PIK3CA mutation) | Experimental | RGT-490 given alone as monotherapy |
|
| Phase 1b Dose Expansion (HR+/HER2- locally advanced or metastatic breast cancer) | Experimental | RGT-490 given alone as monotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RGT-490 | Drug | Oral tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose limiting toxicities (DLTs) | Number of subjects who experience at least 1 Dose Limiting Toxicity (DLT) | 4 weeks (1 cycle) |
| Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) and AEs leading to dose modifications and dose limiting toxicities (DLTs) to determine the maximum tolerated dose (MTD) | Every cycle (4-week cycles) until study discontinuation, approximately 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Characterize the Cmax (PK) of RGT-490 monotherapy in Dose Escalation | Maximum observed plasma concentration (Cmax) of RGT-490 | First 3 treatment cycles (each cycle is 28 days) |
| Characterize the Tmax (PK) of RGT-490 monotherapy in Dose Escalation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Wheeler | Contact | 857-331-3898 | Sarah.Wheeler@regor.com | |
| Regor Pharmaceuticals Central Office | Contact | 617-315-9070 | RGT-490-101@regor.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| START Los Angeles | Recruiting | Los Angeles | California | 90025 | United States | |
| The University of Texas MD Anderson Cancer Center |
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Maximum observed plasma concentration (Tmax) of RGT-490
| First 3 treatment cycles (each cycle is 28 days) |
| Characterize the AUC (PK) of RGT-490 monotherapy in Dose Escalation | Calculated area under the plasma concentration curve (AUC) of RGT-490 | First 3 treatment cycles (each cycle is 28 days) |
| Measure PD effects of RGT-490 monotherapy in Dose Escalation and Phase 1b | Change from baseline in ctDNA levels; Change from baseline in PD markers in paired biopsies | First 7 cycles (each cycle is 28 days) and at study discontinuation |
| Changes in fasting blood glucose | Measured by fasting blood glucose | Approximately every week in Cycle 1 and Cycle 2 (4-week cycle), every 2 weeks in Cycles 3-6 (4-week cycle), and every cycle through end of treatment (4-week cycles), approximately 24 months |
| Changes in longitudinal glucose metabolism (All Phases) | Measured by HbA1c | Approximately every cycle (4-week cycles) until study discontinuation, approximately 24 months |
| Assess preliminary efficacy of RGT-490 monotherapy in dose escalation and Phase 1b | Objective response rate (ORR) based on RECIST v1.1 | Approximately every 8 weeks until progressive disease, approximately 12 months |
| Evaluate additional measures of efficacy of RGT-490 | Duration of response (DoR) according to RECIST v1.1 | Approximately every 8 weeks until progressive disease, approximately 36 months |
| Evaluate additional measures of efficacy of RGT-490 | Progression free survival (PFS) according to RECIST v1.1 | Approximately every 8 weeks until progressive disease, approximately 36 months |
| Not yet recruiting |
| Houston |
| Texas |
| 77030 |
| United States |
| NEXT Houston | Recruiting | Houston | Texas | 77054 | United States |
| NEXT San Antonio | Recruiting | San Antonio | Texas | 78229 | United States |
| NEXT Virginia | Recruiting | Fairfax | Virginia | 22031 | United States |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010051 | Ovarian Neoplasms |
| D016889 | Endometrial Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D014594 | Uterine Neoplasms |
| D014591 | Uterine Diseases |
| D002577 | Uterine Cervical Diseases |
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