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

Description

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 CancerEndometrial CancerOvarian CancerLung Squamous Cell CarcinomaHead and Neck Squamous Cell CarcinomaEsophageal Squamous Cell CarcinomaSolid TumorCervical Cancer
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Related Conditions:

Breast CancerEndometrial CancerOvarian CancerLung Squamous Cell CarcinomaHead and Neck Squamous Cell CarcinomaEsophageal Squamous Cell CarcinomaSolid TumorCervical Cancer

Study Overview

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Study Details

Study 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.

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

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

Condition
Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Huntersville

Carolina BioOncology Institute, Huntersville, North Carolina, United States, 28078

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Terremoto Biosciences Inc.,

Study Record Dates

2029-02-28