A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations

New Cancer Drug TER-2013 Tested in Advanced Solid Tumors

NCT: NCT07109726 · Status: RECRUITING · Phase: Phase 2 · Sponsor: Terremoto Biosciences Inc. · Started: 2025-09-23 · Est. Completion: 2029-02-28

Plain English Summary

A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations is a Phase 2 clinical trial sponsored by Terremoto Biosciences Inc. studying Breast Cancer, Endometrial Cancer, Ovarian Cancer, Lung Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma, Esophageal Squamous Cell Carcinoma, Solid Tumor, Cervical Cancer. This trial is testing a new drug called TER-2013, alone or with another drug (fulvestrant), to see if it's safe and effective for treating advanced solid tumors. It is for patients with certain types of advanced solid tumors that have specific genetic changes in the AKT/PI3K/PTEN pathway. Participation involves taking the study drug(s) and having regular medical check-ups, tests, and scans to monitor your health and the tumor's response. Alternative treatments may include standard chemotherapy, targeted therapies, or immunotherapy, depending on the specific cancer type and prior treatments. The trial aims to enroll 205 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Patients with advanced solid tumors that have specific genetic alterations in the AKT/PI3K/PTEN pathway can join. Patients with certain types of cancer, including breast, ovarian, cervical, and specific lung, head and neck, or esophageal cancers, may be eligible. Patients must be generally healthy with good organ function and an ECOG performance status of 0 or 1 (meaning they are capable of full self-care to fully ambulatory and able to do light work). Patients cannot have certain other genetic mutations (EGFR, KRAS, NRAS, HRAS, or BRAF), active brain metastases, or a history of significant bleeding. This trial is studying Breast Cancer, Endometrial Cancer, Ovarian Cancer, Lung Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma, Esophageal Squamous Cell Carcinoma, Solid Tumor, Cervical Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcomes measure how safe the drug is by looking at side effects and how well it shrinks tumors, which helps determine if the drug is effective and tolerable for patients. The specific primary outcome measures are: Number of Patients who Experience Dose-Limiting Toxicity (28 Days); Number of patients who experience a treatment-related adverse event (Up to 2 years); Objective Response Rate as assessed by RECIST v1.1 (Up to 2 years); Duration of Response as assessed by RECIST v1.1 (Up to 2 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial addresses a need for new treatments for patients with advanced solid tumors that have specific genetic alterations, potentially offering a new option where current therapies may be limited. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Breast Cancer, Endometrial Cancer, Ovarian Cancer, Lung Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma, Esophageal Squamous Cell Carcinoma, Solid Tumor, Cervical Cancer, where improved treatment options are needed.

Investor Insight

This trial signals a potential new targeted therapy for a subset of cancer patients, with Terremoto Biosciences Inc. investing in its development, suggesting a belief in its therapeutic potential and Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor about the specific genetic alterations in your tumor and if they make you eligible for this trial. Understand that you will need to travel to study sites for appointments, tests, and drug administration, and discuss how this will fit into your daily life. Be prepared for regular blood tests, scans, and doctor visits to monitor your health and the effectiveness of the treatment. This trial is currently recruiting participants. The trial is being conducted at 15 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility 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

Trial Locations

Frequently Asked Questions

What is clinical trial NCT07109726?

NCT07109726 is a Phase 2 INTERVENTIONAL study titled "A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations." It is currently recruiting and is sponsored by Terremoto Biosciences Inc.. The trial targets enrollment of 205 participants.

What conditions does NCT07109726 study?

This trial investigates treatments for Breast Cancer, Endometrial Cancer, Ovarian Cancer, Lung Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma, Esophageal Squamous Cell Carcinoma, Solid Tumor, Cervical Cancer. The primary condition under study is Breast Cancer.

What treatments are being tested in NCT07109726?

The interventions being studied include: TER-2013 (DRUG), Fulvestrant injection (DRUG). Oral Capsules

What does Phase 2 mean for NCT07109726?

Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.

What is the current status of NCT07109726?

This trial is currently "Recruiting." It started on 2025-09-23. The estimated completion date is 2029-02-28.

Who is sponsoring NCT07109726?

NCT07109726 is sponsored by Terremoto Biosciences Inc.. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT07109726?

The trial aims to enroll 205 participants. The trial is currently recruiting and accepting new participants.

How is NCT07109726 designed?

This is a interventional study, uses non_randomized allocation, follows a parallel design, employs none masking.

What are the primary outcomes being measured in NCT07109726?

The primary outcome measures are: Number of Patients who Experience Dose-Limiting Toxicity (28 Days); Number of patients who experience a treatment-related adverse event (Up to 2 years); Objective Response Rate as assessed by RECIST v1.1 (Up to 2 years); Duration of Response as assessed by RECIST v1.1 (Up to 2 years). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT07109726 being conducted?

This trial is being conducted at 15 sites, including Orlando, Florida; Boston, Massachusetts; Rochester, Minnesota; St Louis, Missouri and 11 more sites (United States, Puerto Rico).

Where can I find official information about NCT07109726?

The official record for NCT07109726 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07109726. This government database provides the most up-to-date and detailed information about the trial.

What is NCT07109726 testing in simple terms?

This trial is testing a new drug called TER-2013, alone or with another drug (fulvestrant), to see if it's safe and effective for treating advanced solid tumors. It is for patients with certain types of advanced solid tumors that have specific genetic changes in the AKT/PI3K/PTEN pathway.

Why is this trial significant?

This trial addresses a need for new treatments for patients with advanced solid tumors that have specific genetic alterations, potentially offering a new option where current therapies may be limited.

What are the potential risks of participating in NCT07109726?

Common side effects may include nausea, fatigue, diarrhea, and skin rash, as seen with similar targeted therapies. More serious risks could include effects on blood sugar levels, potential bleeding events, or problems with how your body absorbs medication. The study drug may interact with other medications, so it's crucial to inform your doctor about all medicines you are taking. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT07109726?

Ask your doctor about the specific genetic alterations in your tumor and if they make you eligible for this trial. Understand that you will need to travel to study sites for appointments, tests, and drug administration, and discuss how this will fit into your daily life. Be prepared for regular blood tests, scans, and doctor visits to monitor your health and the effectiveness of the treatment. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT07109726 signal from an investment perspective?

This trial signals a potential new targeted therapy for a subset of cancer patients, with Terremoto Biosciences Inc. investing in its development, suggesting a belief in its therapeutic potential and This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.

What happens if the treatment in this trial doesn't work?

Participation involves taking the study drug(s) and having regular medical check-ups, tests, and scans to monitor your health and the tumor's response. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.