Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to characterize the safety and tolerability of ALTA2618 in adults with AKT1 E17K-mutant advanced solid tumors.
This is an open-label, multicenter, Phase 1/1b study of ALTA2618, a mutant-selective and orally bioavailable AKT1 E17K inhibitor, in adults with AKT1 E17K-mutant solid tumors. This study will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary clinical activity of ALTA2618, and aims to find the best dose. The study consists of two parts: Part 1 - Dose Escalation and Part 1b - Dose Expansion.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALTA2618 | Experimental | ALTA2618 will be administered continuously at a protocol-defined dose based on cohort assignment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALTA2618 | Drug | Oral ALTA2618 tablets will be administered at protocol-defined dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Number of participants that experience treatment-emergent adverse events (TEAEs). | Up to 39 months |
| Dose Limiting Toxicities | Number of participants with Dose Limiting Toxicities (DLTs). | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Cmax | Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 8: Predose and up to 24 hours postdose |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other inclusion/exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Study Medical Director | Alterome Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | La Jolla | California | 92093 | United States | ||
| Research Site |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Tmax
| Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 8: Predose and up to 24 hours postdose |
| Area Under Plasma Concentration Time Curve During the Dosing Interval (AUCt) | AUCt | Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 8: Predose and up to 24 hours postdose |
| Terminal Half-Life (t1/2) | t1/2 | Cycle 1 (each cycle is 21 days) Lead-in phase: Predose and up to 72 hours postdose |
| Overall Response Rate (ORR) | Assess per RECIST 1.1 | Up to 39 months |
| Duration of Response (DOR) | Assess per RECIST 1.1 | Up to 39 months |
| Progression-Free Survival (PFS) | Assess per RECIST 1.1 | Up to 39 months |
| Overall Survival (OS) | Assess per RECIST 1.1 | Up to 39 months |
| Denver |
| Colorado |
| 80218 |
| United States |
| Research Site | Sarasota | Florida | 34232 | United States |
| Research Site | Atlanta | Georgia | 30322 | United States |
| Research Site | Boston | Massachusetts | 02114 | United States |
| Research Site | Boston | Massachusetts | 02215 | United States |
| Research Site | St Louis | Missouri | 63110 | United States |
| Research Site | Maumee | Ohio | 43637 | United States |
| Research Site | Nashville | Tennessee | 37203 | United States |
| Research Site | Houston | Texas | 77030 | United States |
| Research Site #2 | San Antonio | Texas | 78229 | United States |
| Research Site | San Antonio | Texas | 78229 | United States |
| Research Site | Fairfax | Virginia | 22031 | United States |
| Research Site | Madison | Wisconsin | 53792 | United States |
| Research Site | Blacktown | New South Wales | 2148 | Australia |
| Research Site | Randwick | New South Wales | 2031 | Australia |
| Research Site | South Brisbane | Queensland | 4101 | Australia |
| Research Site | Malvern | Victoria | 3144 | Australia |
| Research Site | Nedlands | Western Australia | 6009 | Australia |
| Research Site | Caen | 14000 | France |
| Research Site | Dijon | 21000 | France |
| Research Site | Saint-Herblain | 44805 | France |
| Research Site | Villejuif | 94800 | France |
| Research Site | Kyoto | 606-8507 | Japan |
| Research Site | Matsuyama | 791-0280 | Japan |
| Research Site | Shizuoka | 411-8777 | Japan |
| Research Site | Tokyo | 135-8550 | Japan |
| Research Site | Seoul | 03722 | South Korea |
| Research Site | Seoul | 05505 | South Korea |
| Research Site | Seoul | 06591 | South Korea |
| Research Site | Seoul | 13620 | South Korea |
| Research Site | Barcelona | 08023 | Spain |
| Research Site | Barcelona | 08035 | Spain |
| Research Site | Barcelona | 08908 | Spain |
| Research Site | Madrid | 28023 | Spain |
| Research Site | Madrid | 28040 | Spain |
| Research Site | Valencia | 46010 | Spain |
| Research Site | Changhua | 500 | Taiwan |
| Research Site | Taipei | 100 | Taiwan |
| Research Site | Taipei | 10449 | Taiwan |
| Research Site | London | SW3 6JJ | United Kingdom |
| Research Site | London | W1G 6AD | United Kingdom |
| Research Site | London | W1T 7HA | United Kingdom |
| Research Site | Manchester | M10 4BX | United Kingdom |
| Research Site | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Research Site | Sutton | SM2 5PT | United Kingdom |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D001943 | Breast Neoplasms |
| D016889 | Endometrial Neoplasms |
| D009362 | Neoplasm Metastasis |
| D064726 | Triple Negative Breast Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D002583 | Uterine Cervical Neoplasms |
| D010051 | Ovarian Neoplasms |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014594 | Uterine Neoplasms |
| D014565 | Urogenital Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002577 | Uterine Cervical Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided