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

Sponsor: Terremoto Biosciences Inc.

Sponsor score: 0

ClinicalTrials ID:NCT07109726

This Phase 1/2 trial assesses TER-2013's safety, tolerability, and pharmacokinetics as a monotherapy and with fulvestrant in patients with advanced solid tumors. The study includes dose escalation and expansion phases to determine the maximum tolerated dose and preliminary efficacy. Interventions involve oral TER-2013 and fulvestrant injections.

Patient Parameters

Program Overview

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.

Description

This is a first-in-human clinical trial that will evaluate the safety, tolerability, and pharmacokinetics (PK) of TER-2013 as a monotherapy and in combination with fulvestrant and to determine the maximum tolerated/administered dose and preliminary clinical activity. The study consists of two parts: Part 1-Dose Escalation and Part 2 -Dose Expansion.

Eligibility Criteria

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

Locations

FACILITYZIPCITYSTATE
Florida Cancer Specialists - Lake Nona32827OrlandoFlorida
Massachusetts General Hospital02144BostonMassachusetts
Nebraska Cancer Specialists68130OmahaNebraska
Carolina BioOncology Institute28078HuntersvilleNorth Carolina
Sarah Cannon Nashville37203NashvilleTennessee
NEXT Oncology78229AustinTexas
START Center for Cancer Research78229San AntonioTexas
START Center for Cancer Research84119West Valley CityUtah
NEXT Oncology22031FairfaxVirginia

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