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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations
- ClinicalTrials.gov ID
- NCT07109726
- Acronym / sponsor ID
- TER-2013-C01
- Conditions
- Breast Cancer, Endometrial Cancer, Ovarian Cancer, Lung Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma, Esophageal Squamous Cell Carcinoma
- Keywords
- AKT/PI3K/PTEN Alterations, Breast Cancer, Advanced Solid Tumors, HR+/HER2-
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 205 participants (estimated)
- Lead sponsor
- Terremoto Biosciences Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Sep 2025 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 7 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Monotherapy Dose Escalation | Experimental | Drug: TER-2013 |
| Combination Therapy Dose Escalation | Experimental | Drug: TER-2013, Drug: Fulvestrant injectionDose Escalation of TER-2013 with recommended dose of fulvestrant |
| Monotherapy Dose Expansion | Experimental | Drug: TER-2013 |
| Combination Therapy Dose Expansion | Experimental | Drug: TER-2013, Drug: Fulvestrant injectionDose Expansion of TER-2013 with recommended dose of fulvestrant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Metastatic or locally advanced, unresectable disease
- No available treatment with curative intent
- Presence of lesions to be evaluated per RECIST v1.1:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TER-2013Oral Capsules | Drug | Combination Therapy Dose Escalation, Combination Therapy Dose Expansion, Monotherapy Dose Escalation, Monotherapy Dose Expansion |
| Fulvestrant injectionFulvestrant 500 mg Intramuscular Injection | Drug | Combination Therapy Dose Escalation, Combination Therapy Dose Expansion |
Primary outcome
Number of Patients who Experience Dose-Limiting Toxicity
Time frame: 28 Days
Number of patients who experience a treatment-related adverse event
Time frame: Up to 2 years
Objective Response Rate as assessed by RECIST v1.1
Time frame: Up to 2 years
Duration of Response as assessed by RECIST v1.1
Time frame: Up to 2 years
6 secondary outcomes
Area under the plasma concentration-time curve for a dosing interval (AUCτ) of TER-2013
Time frame: Up to 2 years
Maximum concentration (Cmax) of TER-2013
Time frame: Up to 2 years
Time to maximum concentration (Tmax) of TER-2013
Time frame: Up to 2 years
Terminal elimination half-life (T1/2) of TER-2013
Time frame: Up to 2 years
Changes of pharmacodynamic markers of TER-2013 in tissue and/or blood as assessed by pAKT
Time frame: Up to 2 years
Changes of pharmacodynamic markers of TER-2013 in tissue and/or blood as assessed by pPRAS40
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Terremoto Biosciences, Inc. Clinical Trials Central Contact contact
20 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Portugal, Puerto Rico, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Terremoto Biosciences, Inc. Clinical Trials Central Contact (888-682-1551, clinicaltrials@terremotobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients who Experience Dose-Limiting Toxicity (time frame: 28 Days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.