TER-2013 for advanced solid tumors with AKT/PI3K/PTEN pathway changes
A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations
PHASE1; PHASE2 · Terremoto Biosciences Inc. · NCT07109726
This trial tests whether TER-2013, alone or with fulvestrant, is safe and can help people with advanced breast, ovarian, endometrial, lung, or head-and-neck cancers that have AKT/PI3K/PTEN pathway alterations.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 205 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Terremoto Biosciences Inc. (industry) |
| Locations | 15 sites (Orlando, Florida and 14 other locations) |
| Trial ID | NCT07109726 on ClinicalTrials.gov |
What this trial studies
This first-in-human, open-label Phase 1/2 study gives TER-2013 as a monotherapy and in combination with fulvestrant to patients whose advanced solid tumors harbor AKT/PI3K/PTEN pathway alterations. Part 1 uses dose escalation to identify the maximum tolerated or recommended dose and to characterize safety, tolerability, and pharmacokinetics/pharmacodynamics. Part 2 expands selected cohorts to look for preliminary anti-tumor activity in specific tumor types. Patients must have measurable or evaluable disease, adequate organ function, and an ECOG performance status of 0 or 1, with enrollment at multiple US cancer centers.
Who should consider this trial
Good fit: Ideal candidates are adults with metastatic or unresectable solid tumors harboring eligible AKT/PI3K/PTEN alterations, measurable disease, ECOG 0–1, and adequate organ function who have no available curative treatment options.
Not a fit: Patients without AKT/PI3K/PTEN pathway alterations, those with poor performance status (ECOG >1), inadequate organ function, or who have effective curative treatment options are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, TER-2013 could offer a new targeted treatment option for patients whose tumors have AKT/PI3K/PTEN pathway alterations.
How similar studies have performed: Other drugs targeting the PI3K/AKT pathway have shown benefit in selected cancers (for example, PI3K inhibitors in PIK3CA-mutant breast cancer), but TER-2013 is a first-in-human agent and its effects are not yet known.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria
* Metastatic or locally advanced, unresectable disease
* 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
Key Inclusion Criteria for TER-2013 monotherapy arms:
* 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
Key Inclusion Criteria for TER-2013 and fulvestrant combination arms
* 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
Key Exclusion Criteria:
* 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:
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.
Other protocol-defined Inclusion/Exclusion Criteria apply
Where this trial is running
Orlando, Florida and 14 other locations
- Florida Cancer Specialists - Lake Nona — Orlando, Florida, United States (RECRUITING)
- Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
- Mayo Rochester — Rochester, Minnesota, United States (NOT_YET_RECRUITING)
- Washington Univ. School of Medicine — St Louis, Missouri, United States (RECRUITING)
- Nebraska Cancer Specialists — Omaha, Nebraska, United States (RECRUITING)
- Carolina BioOncology Institute — Huntersville, North Carolina, United States (RECRUITING)
- UH Cleveland Medical Center — Cleveland, Ohio, United States (RECRUITING)
- Sarah Cannon Nashville — Nashville, Tennessee, United States (RECRUITING)
- NEXT Oncology — Austin, Texas, United States (RECRUITING)
- MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
- START Center for Cancer Research — San Antonio, Texas, United States (RECRUITING)
- START Center for Cancer Research — West Valley City, Utah, United States (RECRUITING)
- NEXT Oncology — Fairfax, Virginia, United States (RECRUITING)
- Froedtert & MCW Cancer Center — Milwaukee, Wisconsin, United States (RECRUITING)
- PanOncology Trials — San Juan, Puerto Rico (RECRUITING)
Study contacts
- Study coordinator: Terremoto Biosciences, Inc. Clinical Trials Central Contact
- Email: clinicaltrials@terremotobio.com
- Phone: 888-682-1551
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, Endometrial Cancer, Ovarian Cancer, Lung Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma, Esophageal Squamous Cell Carcinoma, Solid Tumor, Cervical Cancer