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

Required: AKT1 pathway alteration

Advanced solid tumor malignancy harboring an eligible AKT/PI3K/PTEN pathway alteration detected by a sponsor approved test

Required: PIK3CA pathway alteration

Advanced solid tumor malignancy harboring an eligible AKT/PI3K/PTEN pathway alteration detected by a sponsor approved test

Required: PTEN pathway alteration

Advanced solid tumor malignancy harboring an eligible AKT/PI3K/PTEN pathway alteration detected by a sponsor approved test

Excluded: EGFR oncogenic-driver co-mutation

Known EGFR, KRAS, NRAS, HRAS, or BRAF oncogenic-driver co-mutation with PI3K/AKT/PTEN alteration

Excluded: KRAS oncogenic-driver co-mutation

Known EGFR, KRAS, NRAS, HRAS, or BRAF oncogenic-driver co-mutation with PI3K/AKT/PTEN alteration

Excluded: NRAS oncogenic-driver co-mutation

Known EGFR, KRAS, NRAS, HRAS, or BRAF oncogenic-driver co-mutation with PI3K/AKT/PTEN alteration

Excluded: HRAS oncogenic-driver co-mutation

Known EGFR, KRAS, NRAS, HRAS, or BRAF oncogenic-driver co-mutation with PI3K/AKT/PTEN alteration

Excluded: BRAF oncogenic-driver co-mutation

Known EGFR, KRAS, NRAS, HRAS, or BRAF oncogenic-driver co-mutation with PI3K/AKT/PTEN alteration

Must have received: standard therapies appropriate for their tumor type and stage — advanced

Received standard therapies appropriate for their tumor type and stage, unless contraindicated, intolerable, or patient refused

Must have received: aromatase inhibitor — advanced unresectable or metastatic

Received treatment with an AI containing regimen (single agent or in combination)

Cannot have received: AKT inhibitor

Prior therapy: [For TER-2013 monotherapy escalation]: AKT inhibitor

Cannot have received: AKT/PI3K/PTEN pathway inhibitor

Prior therapy: [For TER-2013 monotherapy expansion]: AKT/PI3K/PTEN pathway inhibitor

Cannot have received: AKT/PI3K/PTEN pathway inhibitor

Exception: some PIK3CA-altered cohorts allow prior PI3K inhibitor

Prior therapy: [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.

Cannot have received: fulvestrant

Prior therapy: [For TER-2013 + fulvestrant combination expansion]: ...fulvestrant and other SERDs...

Cannot have received: selective estrogen receptor degrader

Prior therapy: [For TER-2013 + fulvestrant combination expansion]: ...other SERDs...

Cannot have received: mTOR inhibitor

Prior therapy: [For TER-2013 + fulvestrant combination expansion]: ...mTOR inhibitor...