A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations
NCT ID: NCT07109726
Last Updated: 2026-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
205 participants
INTERVENTIONAL
2025-09-23
2029-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Monotherapy Dose Escalation
TER-2013
Oral Capsules
Combination Therapy Dose Escalation
Dose Escalation of TER-2013 with recommended dose of fulvestrant
TER-2013
Oral Capsules
Fulvestrant injection
Fulvestrant 500 mg Intramuscular Injection
Monotherapy Dose Expansion
TER-2013
Oral Capsules
Combination Therapy Dose Expansion
Dose Expansion of TER-2013 with recommended dose of fulvestrant
TER-2013
Oral Capsules
Fulvestrant injection
Fulvestrant 500 mg Intramuscular Injection
Interventions
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TER-2013
Oral Capsules
Fulvestrant injection
Fulvestrant 500 mg Intramuscular Injection
Eligibility Criteria
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Inclusion Criteria
* No available treatment with curative intent
* Presence of lesions to be evaluated per RECIST v1.1:
a. 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:
a. \[For TER-2013 dose escalation\]: 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:
1. \[For TER-2013 dose escalation\]: Received standard therapies appropriate for their tumor type and stage, unless contraindicated, intolerable, or patient refused
2. \[For TER-2013 cohort expansion\]: No more than 3 prior lines of treatment in the advanced setting
* Histologically confirmed diagnosis of:
a. \[For TER-2013 + fulvestrant dose escalation\]: 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) ii. No more than 3 prior lines of treatment in the advanced unresectable or metastatic setting
* Prior Therapy:
a. \[For TER-2013 + fulvestrant dose escalation\]: 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) ii. No more than 3 prior lines of treatment in the advanced unresectable or metastatic setting
Exclusion Criteria
* Clinically significant abnormalities of glucose metabolism
* Active brain metastases or carcinomatous meningitis.
* History of significant hemoptysis or hemorrhage within 4 weeks prior to first dose of study drug
* 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
* Prior therapy:
1. \[For TER-2013 monotherapy escalation\]: AKT inhibitor
2. \[For TER-2013 monotherapy expansion\]: AKT/PI3K/PTEN pathway inhibitor
3. \[For TER-2013 + fulvestrant combination expansion\]: AKT/PI3K/PTEN pathway inhibitor, fulvestrant and other SERDs, mTOR inhibitor; some PIK3CA-altered cohorts allow prior PI3K inhibitor.
18 Years
ALL
No
Sponsors
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Terremoto Biosciences Inc.
INDUSTRY
Responsible Party
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Locations
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Florida Cancer Specialists - Lake Nona
Orlando, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
Carolina BioOncology Institute
Huntersville, North Carolina, United States
UH Cleveland Medical Center
Cleveland, Ohio, United States
Sarah Cannon Nashville
Nashville, Tennessee, United States
NEXT Oncology
Austin, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
START Center for Cancer Research
San Antonio, Texas, United States
START Center for Cancer Research
West Valley City, Utah, United States
NEXT Oncology
Fairfax, Virginia, United States
PanOncology Trials
San Juan, , Puerto Rico
Countries
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Central Contacts
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Terremoto Biosciences, Inc. Clinical Trials Central Contact
Role: CONTACT
Facility Contacts
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Role: primary
Role: primary
Other Identifiers
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TER-2013-C01
Identifier Type: -
Identifier Source: org_study_id
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