Tests TER-2013 in advanced solid tumors with PI3K pathway changes
Tests TER-2013 in adults with advanced solid tumors having AKT, PI3K or PTEN changes.
Plain-language title generated from the registry record
Registry title: A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations
Key facts
- Where
- Austin, Boston, Cleveland, Duarte, Fairfax, Houston, Huntersville, Irvine, Milwaukee, Nashville, Omaha, Orlando, Rochester, San Antonio, St Louis, West Valley City, and Zion, United StatesSee the 17 sites
- Phase
- Phase 1/2
Where in United States
- NEXT OncologyAustin, United StatesNo longer taking part
- Massachusetts General HospitalBoston, United StatesTaking people
- UH Cleveland Medical CenterCleveland, United StatesTaking people
- City of HopeDuarte, United StatesTaking people
- NEXT OncologyFairfax, United StatesTaking people
- MD Anderson Cancer CenterHouston, United StatesTaking people
- Carolina Biooncology InstituteHuntersville, United StatesNo longer taking part
- City of Hope, IrvineIrvine, United StatesTaking people
- Froedtert & MCW Cancer CenterMilwaukee, United StatesTaking people
- Sarah Cannon NashvilleNashville, United StatesTaking people
- Nebraska Cancer SpecialistsOmaha, United StatesTaking people
- Florida Cancer Specialists - Lake NonaOrlando, United StatesTaking people
- Mayo RochesterRochester, United StatesTaking people
- START Center for Cancer ResearchSan Antonio, United StatesTaking people
- Washington Univ. School of MedicineSt Louis, United StatesTaking people
- START Center for Cancer ResearchWest Valley City, United StatesTaking people
- City of Hope - ChicagoZion, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Terremoto Biosciences Inc.
- Trial code
- NCT07109726
- Record updated
- 28 October 2026
- Original description
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.Read full original descriptionShow less
A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations
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.
Inclusion: Metastatic or locally advanced, unresectable disease; No available treatment with curative intent; Presence of lesions to be evaluated per RECIST v1.1:; Dose Escalation: measurable or evaluable disease b. Cohort Expansion: measurable disease; Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; Adequate organ function; Advanced solid tumor malignancy harboring an eligible AKT/PI3K/PTEN pathway alteration detected by a sponsor approved test; Histologically confirmed diagnosis of:; [For TER-2013 dose escalation]: solid tumor malignancy b. [For TER-2013 cohort expansion]: i. Cohort 1: ovarian cancer, cervical cancer, or squamous cell carcinoma of the head and neck, lung, or esophagus ii. Cohort 2: endometrial adenocarcinoma; Prior therapy:; [For TER-2013 dose escalation]: Received standard therapies appropriate for their tumor type and stage, unless contraindicated, intolerable, or patient refused; [For TER-2013 cohort expansion]: No more than 3 prior lines of treatment in the advanced setting; Histologically confirmed diagnosis of:; [For TER-2013 + fulvestrant dose escalation]: HR+/HER2- advanced unresectable or metastatic breast cancer b. [For TER-2013 + fulvestrant cohort expansion]: i. Received treatment with an AI containing regimen (single agent or in combination), CDK4/6 inhibitor, and PARP inhibitor (if germline BRCA-mutated) ii. No more than 3 prior lines of treatment in the advanced unresectable or metastatic setting; Prior Therapy:; [For TER-2013 + fulvestrant dose escalation]: Received treatment with an AI containing regimen (single agent or in combination) b. [For TER-2013 + fulvestrant cohort expansion]: i. Received treatment with an AI containing regimen (single agent or in combination), CDK4/6 inhibitor, and PARP inhibitor (if germline BRCA-mutated) ii. No more than 3 prior lines of treatment in the advanced unresectable or metastatic setting.
Exclusion: History of significant hemoptysis or hemorrhage within 4 weeks prior to first dose of study drug; Prior therapy:; [For TER-2013 monotherapy escalation]: AKT inhibitor; [For TER-2013 monotherapy expansion]: AKT/PI3K/PTEN pathway inhibitor; [For TER-2013 + fulvestrant combination expansion]: AKT/PI3K/PTEN pathway inhibitor, fulvestrant and other SERDs, mTOR inhibitor; some PIK3CA-altered cohorts allow prior PI3K inhibitor; Other protocol-defined Inclusion/Exclusion Criteria apply; Malabsorption syndrome, nausea and vomiting uncontrolled by medication, or disease significantly affecting gastrointestinal function likely to interfere with the delivery, absorption, or metabolism of TER-2013; Known EGFR, KRAS, NRAS, HRAS, or BRAF oncogenic-driver co-mutation with PI3K/AKT/PTEN alteration; Clinically significant abnormalities of glucose metabolism; Active brain metastases or carcinomatous meningitis.