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 2026-05-22
205
Participants Needed
15
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating TER-2013 in a Phase 1/2 open-label study involving patients with advanced solid tumors that have specific alterations in the AKT/PI3K/PTEN pathway. This first-in-human trial aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor effects of TER-2013 both alone and combined with fulvestrant. The study is conducted across multiple centers and includes patients with cancers such as breast, endometrial, ovarian, lung squamous cell, head and neck squamous cell, esophageal squamous cell, cervical cancer, and other solid tumors. The trial has two main parts: Dose Escalation and Dose Expansion. Participants receive TER-2013 oral capsules either by itself or alongside fulvestrant, an injection given intramuscularly at 500 mg. The Dose Escalation part determines the maximum tolerated dose and assesses safety, while the Dose Expansion evaluates preliminary clinical activity at the recommended dose. Treatment schedules include administration of TER-2013 with recommended doses of fulvestrant where applicable. Participants undergo regular evaluations for safety and treatment effects up to two years. Researchers monitor dose-limiting toxicities within 28 days, treatment-related adverse events, objective response rates, and duration of response according to RECIST criteria. Pharmacokinetic parameters such as drug concentration over time and pharmacodynamic markers in tissue and blood are also assessed. The study involves ongoing safety monitoring and follows participants to gather comprehensive data on TER-2013's effects.
CONDITIONS
Brief 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...
- Age 18 years or older
- Metastatic or locally advanced, unresectable solid tumor with no curative treatment options
- Presence of measurable or evaluable lesions per RECIST v1.1 criteria
- ECOG performance status of 0 or 1
- Adequate organ function
- Tumor harbors eligible AKT/PI3K/PTEN pathway alteration confirmed by approved test
- For monotherapy dose escalation: confirmed solid tumor malignancy
- For monotherapy dose expansion: ovarian, cervical, head and neck, lung, or esophageal squamous cell carcinoma, or endometrial adenocarcinoma
- Prior standard therapies received or no more than 3 prior advanced treatment lines
- For combination arms: HR+/HER2- advanced unresectable or metastatic breast cancer
- Prior treatment with AI-containing regimen for combination arms
- No more than 3 prior lines of treatment in advanced metastatic setting for combination arms
You will not qualify if you...
- Known co-mutations in EGFR, KRAS, NRAS, HRAS, or BRAF with PI3K/AKT/PTEN alteration
- Clinically significant glucose metabolism abnormalities
- Active brain metastases or carcinomatous meningitis
- Significant bleeding within 4 weeks before first dose
- Malabsorption syndrome or uncontrolled nausea/vomiting affecting drug absorption
- Prior treatment with AKT inhibitor for monotherapy dose escalation
- Prior treatment with AKT/PI3K/PTEN pathway inhibitor for monotherapy expansion
- Prior treatment with AKT/PI3K/PTEN pathway inhibitor, fulvestrant, SERDs, or mTOR inhibitor for combination expansion
- Some cohorts allow prior PI3K inhibitor per protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive TER-2013 as monotherapy or in combination with fulvestrant to evaluate safety, tolerability, and preliminary clinical activity.
Repeated dosing cycles with regular visits as per protocol
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
Actively 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
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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