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

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.

Eligibility

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

Conditions10

Interventions2

Locations17 sites

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