OncoMatch/Clinical Trials/NCT07109726
A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations
Is NCT07109726 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments including TER-2013 and Fulvestrant for breast cancer.
Treatment: TER-2013 · Fulvestrant — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Endocrine / hormonal
Other
Cancer type
Breast Carcinoma
Endometrial Cancer
Ovarian Cancer
Non-Small Cell Lung Carcinoma
Head and Neck Squamous Cell Carcinoma
Esophageal Carcinoma
Tumor Agnostic
Cervical Cancer
Biomarker criteria
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
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
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...
Lab requirements
Blood counts
Kidney function
Liver function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Florida Cancer Specialists - Lake Nona · Orlando, Florida
- Massachusetts General Hospital · Boston, Massachusetts
- Mayo Rochester · Rochester, Minnesota
- Washington Univ. School of Medicine · St Louis, Missouri
- Nebraska Cancer Specialists · Omaha, Nebraska
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07109726 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior AKT inhibitor, AKT/PI3K/PTEN pathway inhibitor, AKT/PI3K/PTEN pathway inhibitor disqualifies patients from enrollment.
Does this trial require AKT1?
Yes, AKT1 pathway alteration is a required biomarker for enrollment.
Does this trial require PIK3CA?
Yes, PIK3CA pathway alteration is a required biomarker for enrollment.
Does this trial require PTEN?
Yes, PTEN pathway alteration is a required biomarker for enrollment.
Are patients with EGFR alterations eligible?
No. EGFR oncogenic-driver co-mutation is an exclusion criterion.
Are patients with KRAS alterations eligible?
No. KRAS oncogenic-driver co-mutation is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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