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

NCT07109726 | Recruiting Phase 1 FDA Drug

• 1 other identifier: TER-2013-C01
• Study Type: interventional
• Target: 205
• Locations: 2 countries
• Sites: 15

Brief 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.

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

Keywords

AKT/PI3K/PTEN Alterations; Breast Cancer; Advanced Solid Tumors; HR+/HER2-

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (6)

• Area under the plasma concentration-time curve for a dosing interval (AUCτ) of TER-2013

  Up to 2 years

• Maximum concentration (Cmax) of TER-2013

  Up to 2 years

• Time to maximum concentration (Tmax) of TER-2013

  Up to 2 years

• Terminal elimination half-life (T1/2) of TER-2013

  Up to 2 years

• Changes of pharmacodynamic markers of TER-2013 in tissue and/or blood as assessed by pAKT

  Up to 2 years

Study Arms (4)

Monotherapy Dose Escalation

EXPERIMENTAL

Drug: TER-2013

Combination Therapy Dose Escalation

EXPERIMENTAL

Dose Escalation of TER-2013 with recommended dose of fulvestrant

Drug: TER-2013; Drug: Fulvestrant injection

Monotherapy Dose Expansion

EXPERIMENTAL

Drug: TER-2013

Combination Therapy Dose Expansion

EXPERIMENTAL

Dose Expansion of TER-2013 with recommended dose of fulvestrant

Drug: TER-2013; Drug: Fulvestrant injection

Interventions

TER-2013 DRUG

Oral Capsules

Combination Therapy Dose Escalation; Combination Therapy Dose Expansion; Monotherapy Dose Escalation; Monotherapy Dose Expansion

Fulvestrant injection DRUG

Fulvestrant 500 mg Intramuscular Injection

Combination Therapy Dose Escalation; Combination Therapy Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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:
• \[For TER-2013 dose escalation\]: 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
• 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:

You may not qualify if:

• 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:
• \[For TER-2013 monotherapy escalation\]: 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.

Sponsors & Collaborators

• Terremoto Biosciences Inc.: lead

Study Sites (15)

Florida Cancer Specialists - Lake Nona

Orlando, Florida, 32827, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02144, United States

RECRUITING

Mayo Rochester

Rochester, Minnesota, 55905, United States

NOT YET RECRUITING

Washington Univ. School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

RECRUITING

Carolina BioOncology Institute

Huntersville, North Carolina, 28078, United States

RECRUITING

UH Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

Sarah Cannon Nashville

Nashville, Tennessee, 37203, United States

RECRUITING

NEXT Oncology

Austin, Texas, 78229, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

START Center for Cancer Research

San Antonio, Texas, 78229, United States

RECRUITING

START Center for Cancer Research

West Valley City, Utah, 84119, United States

RECRUITING

NEXT Oncology

Fairfax, Virginia, 22031, United States

RECRUITING

Froedtert & MCW Cancer Center

Milwaukee, Wisconsin, 53226, United States

RECRUITING

PanOncology Trials

San Juan, 00935, Puerto Rico

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Endometrial Neoplasms; Ovarian Neoplasms; Squamous Cell Carcinoma of Head and Neck; Esophageal Squamous Cell Carcinoma; Uterine Cervical Neoplasms

Interventions

Fulvestrant

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Uterine Cervical Diseases

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Terremoto Biosciences, Inc. Clinical Trials Central Contact

CONTACT

888-682-1551; clinicaltrials@terremotobio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: August 7, 2025
• Study Start: September 23, 2025
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): February 28, 2029
• Last Updated: March 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PR (1); US (14)