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:
202552503634
EU Trial (CTIS) Number:
2025-525036-34-00
Study Contact Information:
(210) 593-5651 or [email protected]
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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.

Phase 1 Dose Escalation and Phase 1b Sub-study Combination Dose Escalation / Safety Lead-In: To characterize the safety and tolerability of TER-2013 as monotherapy and in combination with ER antagonists/degraders To determine the maximum tolerated dose (MTD) and/or maximum administered dose (MAD) of TER-2013 as monotherapy and in combination with fulvestrant Phase 1 Cohort Expansion and Phase 1b Sub-study Combination Cohort or Dose Expansion: To evaluate the preliminary clinical activity/efficacy of TER-2013 in advanced solid tumors To evaluate the preliminary clinical activity/efficacy of TER-2013 in combination with ER antagonists/degraders in HR+/HER2− breast cancer

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
Non-Small Cell Lung Cancer
Ovarian
Head & Neck
Endometrial
Digestive & Intestinal
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.
Phase I/II
Sex
Female & Male
Age
18+ years
Study Drug
Drug: EXPERIMENTAL: Combination Therapy Dose Escalation
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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 Mountain Region
West Valley City, UT, United States, 84119
Investigator
William McKean
Status
Recruiting
Condition(s) Treated at Site
Breast Cancers
Non-Small Cell Lung Cancer
Ovarian
Head & Neck
Endometrial
Digestive & Intestinal
Cervical cancer
Location
START San Antonio
San Antonio, TX, United States, 78229
Investigator
Kyriakos Papadopoulos
Status
Recruiting
Condition(s) Treated at Site
Breast Cancers
Non-Small Cell Lung Cancer
Ovarian
Head & Neck
Endometrial
Digestive & Intestinal
Cervical cancer