A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations
Purpose
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.
Conditions
- Breast Cancer
- Endometrial Cancer
- Ovarian Cancer
- Lung Squamous Cell Carcinoma
- Head and Neck Squamous Cell Carcinoma
- Esophageal Squamous Cell Carcinoma
- Solid Tumor
- Cervical Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
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
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Monotherapy Dose Escalation |
|
|
|
Experimental Combination Therapy Dose Escalation |
Dose Escalation of TER-2013 with recommended dose of fulvestrant |
|
|
Experimental Monotherapy Dose Expansion |
|
|
|
Experimental Combination Therapy Dose Expansion |
Dose Expansion of TER-2013 with recommended dose of fulvestrant |
|
Recruiting Locations
Florida Cancer Specialists - Lake Nona
Orlando 4167147, Florida 4155751 32827
Orlando 4167147, Florida 4155751 32827
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02144
Boston 4930956, Massachusetts 6254926 02144
Nebraska Cancer Specialists
Omaha 5074472, Nebraska 5073708 68130
Omaha 5074472, Nebraska 5073708 68130
Carolina BioOncology Institute
Huntersville 4472370, North Carolina 4482348 28078
Huntersville 4472370, North Carolina 4482348 28078
UH Cleveland Medical Center
Cleveland 5150529, Ohio 5165418 44106
Cleveland 5150529, Ohio 5165418 44106
Contact:
833-788-7425
833-788-7425
Sarah Cannon Nashville
Nashville 4644585, Tennessee 4662168 37203
Nashville 4644585, Tennessee 4662168 37203
NEXT Oncology
Austin 4671654, Texas 4736286 78229
Austin 4671654, Texas 4736286 78229
MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
Contact:
877-589-0209
877-589-0209
START Center for Cancer Research
San Antonio 4726206, Texas 4736286 78229
San Antonio 4726206, Texas 4736286 78229
START Center for Cancer Research
West Valley City 5784607, Utah 5549030 84119
West Valley City 5784607, Utah 5549030 84119
NEXT Oncology
Fairfax 4758023, Virginia 6254928 22031
Fairfax 4758023, Virginia 6254928 22031
PanOncology Trials
San Juan 4568127, Puerto Rico 00935
San Juan 4568127, Puerto Rico 00935
More Details
- Status
- Recruiting
- Sponsor
- Terremoto Biosciences Inc.
Study Contact
Terremoto Biosciences, Inc. Clinical Trials Central Contact888-682-1551
clinicaltrials@terremotobio.com
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.