Health Trials

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

ConditionsBreast CancerEndometrial CancerOvarian CancerLung Squamous Cell CarcinomaHead and Neck Squamous Cell CarcinomaEsophageal Squamous Cell CarcinomaSolid TumorCervical Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTerremoto Biosciences Inc.

About this trial

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.

Eligibility criteria

Qualifiers

Metastatic or locally advanced, unresectable disease

No available treatment with curative intent

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Adequate organ function

Disqualifiers

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

Trial design

Treatments tested in this trial

  • TER-2013
  • Fulvestrant injection

Treatment groups

205 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Terremoto Biosciences Inc.

Lead sponsor

Source ClinicalTrials.gov