TER-2013 for advanced solid tumors with AKT/PI3K/PTEN pathway changes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human, open-label Phase 1/2 study gives TER-2013 as a monotherapy and in combination with fulvestrant to patients whose advanced solid tumors harbor AKT/PI3K/PTEN pathway alterations. Part 1 uses dose escalation to identify the maximum tolerated or recommended dose and to characterize safety, tolerability, and pharmacokinetics/pharmacodynamics. Part 2 expands selected cohorts to look for preliminary anti-tumor activity in specific tumor types. Patients must have measurable or evaluable disease, adequate organ function, and an ECOG performance status of 0 or 1, with enrollment at multiple US cancer centers.

Why it matters

Who can join: the full rules

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), CDK4/6 inhibitor, and PARP inhibitor (if germline BRCA-mutated) 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), CDK4/6 inhibitor, and PARP inhibitor (if germline BRCA-mutated) 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

Where it's running

• City of Hope
  Duarte, California, United States Recruiting
• City of Hope, Irvine
  Irvine, California, United States Recruiting
• Florida Cancer Specialists - Lake Nona
  Orlando, Florida, United States Recruiting
• City of Hope, Chicago
  Zion, Illinois, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Mayo Rochester
  Rochester, Minnesota, United States Recruiting

Study contacts

• Study coordinator: Terremoto Biosciences, Inc. Clinical Trials Central Contact
• Email: clinicaltrials@terremotobio.com
• Phone: 888-682-1551

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.