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Recruiting NCT07109726

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

Phase I / Phase II Interventional Breast Cancer Endometrial Cancer Ovarian Cancer Lung Squamous Cell Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TER-2013, Fulvestrant injection.
Who it may be relevant to
Registry conditions: Breast Cancer, Endometrial Cancer, Ovarian Cancer, Lung Squamous Cell Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Puerto Rico
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Detailed 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.

Interventions

  • Drug TER-2013
    Oral Capsules
  • Drug Fulvestrant injection
    Fulvestrant 500 mg Intramuscular Injection

Primary outcome measures

  • Number of Patients who Experience Dose-Limiting Toxicity [Time frame: 28 Days]
  • Number of patients who experience a treatment-related adverse event [Time frame: Up to 2 years]
  • Objective Response Rate as assessed by RECIST v1.1 [Time frame: Up to 2 years]
  • Duration of Response as assessed by RECIST v1.1 [Time frame: Up to 2 years]
Secondary outcome measures (6)
  • Area under the plasma concentration-time curve for a dosing interval (AUCτ) of TER-2013 [Time frame: Up to 2 years]
  • Maximum concentration (Cmax) of TER-2013 [Time frame: Up to 2 years]
  • Time to maximum concentration (Tmax) of TER-2013 [Time frame: Up to 2 years]
  • Terminal elimination half-life (T1/2) of TER-2013 [Time frame: Up to 2 years]
  • Changes of pharmacodynamic markers of TER-2013 in tissue and/or blood as assessed by pAKT [Time frame: Up to 2 years]
  • Changes of pharmacodynamic markers of TER-2013 in tissue and/or blood as assessed by pPRAS40 [Time frame: Up to 2 years]

Eligibility criteria

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

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

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

Other protocol-defined Inclusion/Exclusion Criteria apply

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 14 centers
  • Florida Cancer Specialists - Lake Nona — Orlando
  • Massachusetts General Hospital — Boston
  • Mayo Rochester — Rochester
  • Washington Univ. School of Medicine — St Louis
  • Nebraska Cancer Specialists — Omaha
  • Carolina BioOncology Institute — Huntersville
  • UH Cleveland Medical Center — Cleveland
  • Sarah Cannon Nashville — Nashville
  • … and 6 more centers
Puerto Rico · 1 center
  • PanOncology Trials — San Juan

Identifiers

NCT: NCT07109726 · TER-2013-C01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗