Breast CancerPhase 1/2NCT07109726
A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations
A Phase 1/2 study testing TER-2013 and Fulvestrant injection in people with Breast Cancer and Endometrial Cancer, run by Terremoto Biosciences Inc. at 20 sites in 4 countries.
Trial summary
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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Endometrial Cancer, Ovarian Cancer
- What is being tested?
- TER-2013 and Fulvestrant injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 20 sitesin 4 countries
- Study dates
- 23 Sep 2025to 28 Feb 2029
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- Key Inclusion Criteria for TER-2013 and fulvestrant combination arms
- 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) 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) ii. No more than 3 prior lines of treatment in the advanced unresectable or metastatic setting
Who cannot join
- 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.
- 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:
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- [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
Trial locations and contacts
20 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
Terremoto Biosciences, Inc. Clinical Trials Central Contact contact
20 sites in 4 countries
United States17 sites, 15 recruiting
- Active, not recruiting
NEXT Oncology
Austin, Texas, 78229
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02144
- Recruiting
UH Cleveland Medical Center
Cleveland, Ohio, 44106
833-788-7425
- Recruiting
City of Hope
Duarte, California, 91010
Felicia Lewis, 626-218-5097, flewis@coh.org
- Recruiting
NEXT Oncology
Fairfax, Virginia, 22031
Referral Coordinator, (703) 783-4518, NXTAUS_Coordinators@nextoncology.com
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
877-589-0209
- Withdrawn
Carolina BioOncology Institute
Huntersville, North Carolina, 28078
- Recruiting
City of Hope, Irvine
Irvine, California, 92618
Felicia Lewis, 626-218-5097, flewis@coh.org
- Recruiting
Froedtert & MCW Cancer Center
Milwaukee, Wisconsin, 53226
John Charlson, 414-805-8900, jcharlson@mcw.edu
- Recruiting
Sarah Cannon Nashville
Nashville, Tennessee, 37203
Referral Coordinator, 615.329.7274, asksarah@scresearch.net
- Recruiting
Nebraska Cancer Specialists
Omaha, Nebraska, 68130
Ashley Servais Degenhardt, 402-955-2691, aservais@nebraskacancer.com
- Recruiting
Florida Cancer Specialists - Lake Nona
Orlando, Florida, 32827
Elizabeth Griffith- Gilmore, 904-380-2418, elizabeth.griffith@scri.com
- Recruiting
Mayo Rochester
Rochester, Minnesota, 55905
Clinical Research Recruitment, 507-284-2511, mayocliniccancerstudies@mayo.edu
- Recruiting
START Center for Cancer Research
San Antonio, Texas, 78229
Isabel Jimenez, 210-593-5265, isabel.jimenez@startresearch.com
- Recruiting
Washington Univ. School of Medicine
St Louis, Missouri, 63110
Study Coordinator, 800-600-3606, enix@wustl.edu
- Recruiting
START Center for Cancer Research
West Valley City, Utah, 84119
Marie Assay, 801-907-4770, marie.asay@startresearch.com
- Recruiting
City of Hope, Chicago
Zion, Illinois, 60099
Felicia Lewis, 626-218-5097, flewis@coh.org
Portugal1 site, 1 recruiting
- Recruiting
START Lisboa
Lisbon, Portugal, 1649-035
Recruitment Specialist, +351 21 780 5000, hopeteam@startresearch.com
Puerto Rico1 site, 1 recruiting
- Recruiting
PanOncology Trials
San Juan, 00935
Study Coordinator, info@panoncologytrials.com
Spain1 site, 1 recruiting
- Recruiting
START Madrid, Fundacion Jimenez Diaz
Madrid, Spain, 28040
Recruitment Specialist, +34 91 550 48 00, hopeteam@startresearch.com
About this study
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 the detailed description
This is a first-in-human clinical trial that will evaluate the safety, tolerability, and pharmacokinetics (PK) of TER-2013 as a monotherapy and in combination with fulvestrant and to determine the maximum tolerated/administered dose and preliminary clinical activity. The study consists of two parts: Part 1-Dose Escalation and Part 2 -Dose Expansion.
- Conditions
- Breast Cancer, Endometrial Cancer, Ovarian Cancer, Lung Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma, Esophageal Squamous Cell Carcinoma
- Being tested
- TER-2013, Fulvestrant injection
- Keywords
- AKT/PI3K/PTEN Alterations, Breast Cancer, Advanced Solid Tumors, HR+/HER2-
- Medical subject headings
- Breast Neoplasms, Endometrial Neoplasms, Ovarian Neoplasms, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TER-2013Drug
Oral Capsules
Fulvestrant injectionDrug
Fulvestrant 500 mg Intramuscular Injection
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy Dose Escalation | Experimental | Not described Receives: Drug: TER-2013 |
| Combination Therapy Dose Escalation | Experimental | Dose Escalation of TER-2013 with recommended dose of fulvestrant Receives: Drug: TER-2013; Drug: Fulvestrant injection |
| Monotherapy Dose Expansion | Experimental | Not described Receives: Drug: TER-2013 |
| Combination Therapy Dose Expansion | Experimental | Dose Expansion of TER-2013 with recommended dose of fulvestrant Receives: Drug: TER-2013; Drug: Fulvestrant injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients who Experience Dose-Limiting Toxicity
Measured: 28 Days
Number of patients who experience a treatment-related adverse event
Measured: Up to 2 years
Objective Response Rate as assessed by RECIST v1.1
Measured: Up to 2 years
Duration of Response as assessed by RECIST v1.1
Measured: Up to 2 years
Secondary outcomes (6)
Area under the plasma concentration-time curve for a dosing interval (AUCτ) of TER-2013
Measured: Up to 2 years
Maximum concentration (Cmax) of TER-2013
Measured: Up to 2 years
Time to maximum concentration (Tmax) of TER-2013
Measured: Up to 2 years
Terminal elimination half-life (T1/2) of TER-2013
Measured: Up to 2 years
Changes of pharmacodynamic markers of TER-2013 in tissue and/or blood as assessed by pAKT
Measured: Up to 2 years
Changes of pharmacodynamic markers of TER-2013 in tissue and/or blood as assessed by pPRAS40
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start23 Sep 2025
- Primary completion30 Dec 2028 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 205 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Terremoto Biosciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109726
- Sponsor's protocol ID
- TER-2013-C01
- Status last verified
- Feb 2026
- First submitted
- 24 Jul 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No