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

Launched by TERREMOTO BIOSCIENCES INC. · Jul 30, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new medicine called TER-2013 to see if it is safe and effective for treating certain advanced solid tumors, which are cancers found in organs like the breast, ovary, lung, cervix, and others. The study focuses on patients whose tumors have specific changes in genes involved in cell growth, known as the AKT/PI3K/PTEN pathway. The goal is to learn more about how the drug works in the body, how well patients tolerate it, and whether it can help shrink tumors or slow their growth.

People who may be eligible to join this study are adults with advanced cancer that cannot be removed by surgery and who have already tried standard treatments without success or if no cure-focused treatment is available. Participants need to have measurable disease that doctors can track and be in good enough health to take part. Some groups in the study will receive TER-2013 alone, while others with certain types of breast cancer will receive TER-2013 combined with another treatment called fulvestrant. The trial is still not open for enrollment, and those interested should know that people with certain other gene changes or serious health issues may not qualify. If you join, you can expect careful monitoring by the medical team to watch for side effects and to see how the cancer responds to the treatment.

Gender

ALL

Eligibility criteria

• • 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