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

Not Applicable

Not yet recruiting

• Conditions: Breast Cancer; Lung Squamous Cell Carcinoma; Solid Tumor; Endometrial Cancer; Esophageal Squamous Cell Carcinoma; Cervical Cancer; Ovarian Cancer; Head and Neck Squamous Cell Carcinoma
• Interventions: Drug: TER-2013; Drug: Fulvestrant injection

• Registration Number: NCT07109726
• Lead Sponsor: Terremoto Biosciences Inc.

Brief 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.

Detailed Description

This is a first-in-human clinical trial that will evaluate the safety, tolerability, and pharmacokinetics (PK) of TER-2013 as a monotherapy and in combination with fulvestrant and to determine the maximum tolerated/administered dose and preliminary clinical activity. The study consists of two parts: Part 1-Dose Escalation and Part 2 -Dose Expansion.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-24
• Study First Submitted QC: 2025-07-30
• Last Update Submitted: 2025-07-30
• Study Start: 2025-08-01
• Study First Posted: 2025-08-07
• Last Update Posted: 2025-08-07
• Primary Completion: 2028-12-30
• Study Completion: 2029-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 205

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monotherapy Dose Escalation	TER-2013	-
Combination Therapy Dose Escalation	TER-2013	Dose Escalation of TER-2013 with recommended dose of fulvestrant
Combination Therapy Dose Escalation	Fulvestrant injection	Dose Escalation of TER-2013 with recommended dose of fulvestrant
Monotherapy Dose Expansion	TER-2013	-
Combination Therapy Dose Expansion	TER-2013	Dose Expansion of TER-2013 with recommended dose of fulvestrant
Combination Therapy Dose Expansion	Fulvestrant injection	Dose Expansion of TER-2013 with recommended dose of fulvestrant

Primary Outcome Measures

Name	Time	Method
Number of Patients who Experience Dose-Limiting Toxicity	28 Days
Number of patients who experience a treatment-related adverse event	Up to 2 years
Objective Response Rate as assessed by RECIST v1.1	Up to 2 years
Duration of Response as assessed by RECIST v1.1	Up to 2 years

Secondary Outcome Measures

Name	Time	Method
Maximum concentration (Cmax) of TER-2013	Up to 2 years
Time to maximum concentration (Tmax) of TER-2013	Up to 2 years
Terminal elimination half-life (T1/2) of TER-2013	Up to 2 years
Area under the plasma concentration-time curve for a dosing interval (AUCτ) of TER-2013	Up to 2 years
Changes of pharmacodynamic markers of TER-2013 in tissue and/or blood as assessed by pPRAS40	Up to 2 years
Changes of pharmacodynamic markers of TER-2013 in tissue and/or blood as assessed by pAKT	Up to 2 years