Trial Title:
Study of TNG260 and an Anti-PD Antibody in STK11 Mutated Solid Tumors
NCT ID:
NCT05887492
Condition:
Non Small Cell Lung Cancer
Solid Tumors, Adult
Endometrial Cancer
Pancreatic Cancer
Cervical Cancer
Breast Cancer
Carcinoma of Unknown Primary
Conditions: Official terms:
Endometrial Neoplasms
Pembrolizumab
Conditions: Keywords:
STK11
KRAS
LKB1
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Intervention model description:
Phase 1 (Dose Escalation) and Phase 2 (Dose Expansion)
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TNG260
Description:
CoREST inhibitor, administered orally
Arm group label:
Dose Escalation
Arm group label:
Dose Expansion in Advanced or Metastatic Solid Tumors
Arm group label:
Dose Expansion in NSCLC with KRAS Mutation
Arm group label:
Dose Expansion in NSCLC with KRAS Wild type
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
Pembrolizumab, an anti-PD-1 antibody, administered intravenously
Arm group label:
Dose Escalation
Arm group label:
Dose Expansion in Advanced or Metastatic Solid Tumors
Arm group label:
Dose Expansion in NSCLC with KRAS Mutation
Arm group label:
Dose Expansion in NSCLC with KRAS Wild type
Other name:
Keytruda
Summary:
The goal of this interventional clinical trial is to learn about TNG260, a CoREST
inhibitor, in combination with pembrolizumab in patients with advanced solid tumors with
a known STK11 mutation.
The main question[s] it aims to answer are:
- the recommended dose for Phase 2
- to evaluate the safety and tolerability of the combination therapy
- to determine the pharmacokinetics of TNG260
- to evaluate the initial antineoplastic activity
Participants will receive study treatment until they experience an undesirable side
effect, their disease progresses or until they withdraw consent.
Detailed description:
This is a first-in-human Phase 1/2, open-label, multicenter, dose-escalation and
expansion study designed to determine the maximum tolerated dose and recommended phase 2
dose(s) and evaluate the safety and tolerability, pharmacokinetics, and antineoplastic
activity of escalating oral doses of TNG260 when administered with a standard dose of
pembrolizumab in participants with locally advanced or metastatic STK11 mutated solid
tumors.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Is ≥18 years of age at the time of signature of the main study ICF.
- Has ECOG performance status of 0 or 1.
- Has measurable disease based on RECIST v1.1.
- All participants must have documented STK11 mutation in a solid tumor, which is
identified through a validated analytical method
- Has confirmed histologic or cytologic diagnosis of a locally advanced or metastatic
solid tumor.
- Adequate organ function/reserve per local labs
- Adequate liver function per local labs
- Adequate renal function per local labs
- Negative serum pregnancy test result at screening
- Written informed consent must be obtained according to local guidelines
Exclusion Criteria:
- Known allergies, hypersensitivity, or intolerance to TNG260, PD-1 antibody or its
excipients
- Uncontrolled intercurrent illness that will limit compliance with the study
requirements
- Active infection requiring systemic therapy
- Currently participating in or has planned participation in a study of another
investigational agent or device
- Impairment of GI function or disease that may significantly alter the absorption of
oral TNG260
- Active prior or concurrent malignancy.
- Central nervous system metastases associated with progressive neurological symptoms
- Current active liver disease from any cause
- Clinically relevant cardiovascular disease
- A female patient who is pregnant or lactating
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UCLA Hematology/Oncology
Address:
City:
Santa Monica
Zip:
90404
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Jonathan Goldman, MD
Email:
Principal Investigator
Facility:
Name:
SCRI at HealthOne
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Gerald Falchook, MD
Email:
Principal Investigator
Facility:
Name:
Florida Cancer Specialists
Address:
City:
Sarasota
Zip:
34232
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Judy Wang, MD
Email:
Principal Investigator
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Mark Awad, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Henry Ford Health System
Address:
City:
Detroit
Zip:
48202
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Shiresh Gadgeel, MD
Email:
Principal Investigator
Facility:
Name:
New York University Langone Health
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Salman Punekar, MD
Email:
Principal Investigator
Facility:
Name:
Sarah Cannon Tennessee Oncology
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Investigator:
Last name:
David Spigel, MD
Email:
Principal Investigator
Facility:
Name:
The University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Ferdinandos Skoulidis, MD
Email:
Principal Investigator
Facility:
Name:
NEXT Oncology Virginia
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Alex Spira, MD
Email:
Principal Investigator
Start date:
June 12, 2023
Completion date:
June 2025
Lead sponsor:
Agency:
Tango Therapeutics, Inc.
Agency class:
Industry
Source:
Tango Therapeutics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05887492
