Actively Recruiting
A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations
Led by Terremoto Biosciences Inc. · Updated on 2026-03-23
205
Participants Needed
15
Research Sites
179 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Metastatic or locally advanced, unresectable disease
- No available treatment with curative intent
- Presence of lesions evaluable by RECIST v1.1 criteria
- ECOG performance status of 0 or 1
- Adequate organ function
- Advanced solid tumor with eligible AKT/PI3K/PTEN pathway alteration detected by approved test
- For TER-2013 monotherapy dose escalation: histologically confirmed solid tumor malignancy
- For TER-2013 monotherapy cohort expansion: ovarian, cervical, head and neck, lung, or esophageal squamous cell carcinoma, or endometrial adenocarcinoma
- Prior standard therapies received unless contraindicated or refused (dose escalation)
- No more than three prior advanced treatment lines (cohort expansion)
- For TER-2013 plus fulvestrant arms: HR+/HER2- advanced unresectable or metastatic breast cancer
- Prior treatment with AI-containing regimen
- No more than three prior lines of advanced treatment (combination cohort expansion)
You will not qualify if you...
- Known EGFR, KRAS, NRAS, HRAS, or BRAF oncogenic-driver co-mutations with PI3K/AKT/PTEN alteration
- Clinically significant glucose metabolism abnormalities
- Active brain metastases or carcinomatous meningitis
- Significant hemoptysis or hemorrhage within 4 weeks before first dose
- Malabsorption syndrome or gastrointestinal conditions affecting drug absorption
- Prior AKT inhibitor therapy (dose escalation monotherapy)
- Prior AKT/PI3K/PTEN pathway inhibitor therapy (monotherapy expansion)
- Prior AKT/PI3K/PTEN pathway inhibitor, fulvestrant, SERDs, or mTOR inhibitor therapy (combination expansion), except some PI3K inhibitors allowed in certain cohorts
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Florida Cancer Specialists - Lake Nona
Orlando, Florida, United States, 32827
Actively Recruiting
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02144
Actively Recruiting
3
Mayo Rochester
Rochester, Minnesota, United States, 55905
Not Yet Recruiting
4
Washington Univ. School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
5
Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68130
Actively Recruiting
6
Carolina BioOncology Institute
Huntersville, North Carolina, United States, 28078
Actively Recruiting
7
UH Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
8
Sarah Cannon Nashville
Nashville, Tennessee, United States, 37203
Actively Recruiting
9
NEXT Oncology
Austin, Texas, United States, 78229
Actively Recruiting
10
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
11
START Center for Cancer Research
San Antonio, Texas, United States, 78229
Actively Recruiting
12
START Center for Cancer Research
West Valley City, Utah, United States, 84119
Actively Recruiting
13
NEXT Oncology
Fairfax, Virginia, United States, 22031
Actively Recruiting
14
Froedtert & MCW Cancer Center
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
15
PanOncology Trials
San Juan, Puerto Rico, 00935
Actively Recruiting
Research Team
T
Terremoto Biosciences, Inc. Clinical Trials Central Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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