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

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
• 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:
• \[For TER-2013 monotherapy escalation\]: 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.
• ther protocol-defined Inclusion/Exclusion Criteria apply