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

Study Identifier:
TER-2013-C01
CT.gov Identifier:
NCT07109726
EudraCT Identifier:
202553000000
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study 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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Breast Cancers
  • Endometrial
  • Ovarian
  • Non-Small Cell Lung Cancer
  • Head & Neck
  • Esophageal
  • Solid Tumor
  • Cervical cancer
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: EXPERIMENTAL: Combination Therapy Dose Escalation
    • Read More
  • Drug: Dose Escalation of TER-2013 with recommended dose of fulvestrant
  • Drug: Drug: Fulvestrant injection
  • Drug: Fulvestrant 500 mg Intramuscular Injection
  • Drug: Drug: TER-2013
  • Drug: Oral Capsules
  • Drug: EXPERIMENTAL: Combination Therapy Dose Expansion
  • Drug: Dose Expansion of TER-2013 with recommended dose of fulvestrant
  • Drug: EXPERIMENTAL: Monotherapy Dose Escalation
  • Drug: EXPERIMENTAL: Monotherapy Dose Expansion
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion 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

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Kyriakos Papadopoulos
    Status
    Recruiting
    Condition(s) Treated at Site
    Breast Cancers
    Endometrial
    Ovarian
    Non-Small Cell Lung Cancer
    Head & Neck
    Esophageal
    Solid Tumor
    Cervical cancer
    Location
    START Mountain Region
    West Valley City, UT, United States, 84119
    Investigator
    William McKean
    Status
    Recruiting
    Condition(s) Treated at Site
    Breast Cancers
    Endometrial
    Ovarian
    Non-Small Cell Lung Cancer
    Head & Neck
    Esophageal
    Solid Tumor
    Cervical cancer