A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations

Part of paid clinical trials in Orlando, Florida.

Sponsor
Terremoto Biosciences Inc.
Study ID
NCT07109726
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TER-2013 — DRUG
    Oral Capsules
  • Fulvestrant injection — DRUG
    Fulvestrant 500 mg Intramuscular Injection

Study Details

This is a Phase 1/2, open-label, multicenter study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of TER-2013 in patients with advanced solid tumors harboring AKT/PI3K/PTEN pathway alterations.

Key Dates

Start date
Sep 23, 2025
Status verified
Feb 2026
Primary completion
Dec 30, 2028
Completion
Feb 28, 2029

Study Design

Enrollment
205 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Monotherapy Dose Escalation
  • Experimental: Combination Therapy Dose Escalation
    Dose Escalation of TER-2013 with recommended dose of fulvestrant
  • Experimental: Monotherapy Dose Expansion
  • Experimental: Combination Therapy Dose Expansion
    Dose Expansion of TER-2013 with recommended dose of fulvestrant

Primary Outcome Measure

Number of Patients who Experience Dose-Limiting Toxicity [ Time Frame: 28 Days ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
Florida Cancer Specialists - Lake NonaOrlandoFlorida32827
Elizabeth Griffith- Gilmore
[email protected]
904-380-2418
Massachusetts General HospitalBostonMassachusetts02144-
Mayo RochesterRochesterMinnesota55905
Clinical Research Recruitment
[email protected]
507-284-2511
Washington Univ. School of MedicineSt LouisMissouri63110
Study Coordinator
[email protected]
800-600-3606
Nebraska Cancer SpecialistsOmahaNebraska68130
Ashley Servais Degenhardt
[email protected]
402-955-2691
Carolina BioOncology InstituteHuntersvilleNorth Carolina28078
Ryan Allen
[email protected]
704-947-6599
UH Cleveland Medical CenterClevelandOhio44106
833-788-7425
Sarah Cannon NashvilleNashvilleTennessee37203
Referral Coordinator
[email protected]
615.329.7274
NEXT OncologyAustinTexas78229
Recruitment Coordinator
[email protected]
737-610-5200
MD Anderson Cancer CenterHoustonTexas77030
877-589-0209
START Center for Cancer ResearchSan AntonioTexas78229
Isabel Jimenez
[email protected]
210-593-5265
START Center for Cancer ResearchWest Valley CityUtah84119
Marie Assay
[email protected]
801-907-4770
NEXT OncologyFairfaxVirginia22031
Referral Coordinator
[email protected]
(703) 783-4518
Froedtert & MCW Cancer CenterMilwaukeeWisconsin53226
John Charlson
[email protected]
414-805-8900

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