Non Small Cell Lung CancerPhase 1/2NCT05887492
Study of TNG260 and an Anti-PD Antibody in STK11 Mutated Solid Tumors
A Phase 1/2 study testing TNG260 and Pembrolizumab in people with Non Small Cell Lung Cancer and Solid Tumors, Adult, run by Tango Therapeutics, Inc. at 13 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Solid Tumors, Adult, Lung Cancer
- What is being tested?
- TNG260 and Pembrolizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 13 sitesUnited States
- Study dates
- 12 Jun 2023to Sep 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
Show all 10Show fewer
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
US Oncology Investigational Products Center
Dallas, Texas, 75246
SCRI at HealthOne
Denver, Colorado, 80218
Henry Ford Health System
Detroit, Michigan, 48202
NEXT Oncology Virginia
Fairfax, Virginia, 22031
START MidWest
Grand Rapids, Michigan, 49546
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
NYU Langone Hematology Oncology Associates-Mineola
Mineola, New York, 11501
Sarah Cannon Tennessee Oncology
Nashville, Tennessee, 37203
New York University Langone Health
New York, New York, 10016
US Oncology Investigational Products Center
Norfolk, Virginia, 23502
UCLA Hematology/Oncology
Santa Monica, California, 90404
Florida Cancer Specialists
Sarasota, Florida, 34232
About this study
Official title: A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of TNG260 as Single Agent and in Combination With an Anti-PD-1 Antibody In Patients With STK11 Mutated Advanced Solid Tumors
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.
Read the 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.
- Being tested
- TNG260, Pembrolizumab
- Keywords
- STK11, KRAS wild type, LKB1
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNG260Drug
CoREST inhibitor, administered orally
PembrolizumabDrug
Also called Keytruda
Pembrolizumab, an anti-PD-1 antibody, administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | Participants with STK11-mutant solid tumors will receive escalating doses of TNG260 in combination with pembrolizumab to estimate the MTD Receives: Drug: TNG260; Drug: Pembrolizumab |
| Dose Expansion in NSCLC with KRAS Mutation | Experimental | Participants with STK11-mutant and KRAS-mutant NSCLC (squamous and non squamous) will receive TNG260 at the identified RP2D in combination with pembrolizumab Receives: Drug: TNG260; Drug: Pembrolizumab |
| Dose Expansion in NSCLC with KRAS Wild type | Experimental | Participants with STK11-mutant and KRAS-wild type NSCLC (squamous and non-squamous) will receive TNG260 at the identified RP2D in combination with pembrolizumab Receives: Drug: TNG260; Drug: Pembrolizumab |
| Dose Expansion in Advanced or Metastatic Solid Tumors | Experimental | Participants with STK11-mutant solid tumors (including but not limited to pancreatic, endometrial, cervical, breast, and carcinoma of unknown primary) will receive TNG260 at the identified RP2D in combination with pembrolizumab Receives: Drug: TNG260; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the MTD and RP2D(s) (Phase 1 only)
To determine the MTD and RP2D(s) of TNG260 when administered in combination with pembrolizumab
Measured: 42 days
Measure antitumor activity using RECIST 1.1 (Phase 2 only)
To assess antineoplastic activity of TNG260 when administered in combination with pembrolizumab in participants with locally advanced unresectable or metastatic STK11-mutated solid tumors by measuring ORR, DOR, and PFS by RECIST 1.1
Measured: 12 weeks
Secondary outcomes (8)
Measure antitumor evidence of TNG260 + pembrolizumab antineoplastic activity by RECIST 1.1 (Phase 1 only)
To assess antineoplastic activity of TNG260 when administered in combination with pembrolizumab in participants with locally advanced unresectable or metastatic STK11-mutated solid tumors by measuring ORR, DOR, and PFS by RECIST 1.1
Measured: 12 weeks
Characterize Area Under the Curve (AUC) of TNG260
Measure the plasma concentration versus time curve (AUC) of TNG260 alone and when administered in combination with pembrolizumab
Measured: 37 days
Characterize the time to achieve Time to Maximal Concentration (Tmax) of TNG260
To characterize the Tmax by measuring the plasma concentrations versus time of TNG260 alone and when administered in combination with pembrolizumab
Measured: 37 days
Characterize Maximum Observed Plasma Concentration (Cmax) of TNG260
To characterize the Cmax by measuring the plasma concentrations versus time of TNG260 alone and when administered in combination with pembrolizumab
Measured: 37 days
Characterize Terminal Half-life (T1/2) of TNG260
To characterize the T1/2 by measuring the plasma concentrations versus time of TNG260 alone and when administered in combination with pembrolizumab
Measured: 37 days
Characterize pembrolizumab concentrations when administered with TNG260
To characterize the pre treatment and trough concentration levels of pembrolizumab when administered in combination with TNG260
Measured: 43 days
Safety and tolerability of TNG260 by CTCAE 5.0
To evaluate the safety and tolerability of TNG260 when administered as single agent and in combination with pembrolizumab by measuring the incidence, nature, and severity of AE and SAE graded according to CTCAE v5.0
Measured: 42 days
To measure changes in histone acetylation when administered with TNG260
Measure changes in levels of histone acetylation in blood and/or tumor tissue, on study treatment relative to pre-treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start12 Jun 2023
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Phase 1 (Dose Escalation) and Phase 2 (Dose Expansion)
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tango Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adam Crystal, MD, PhD, Study director, Tango Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887492
- Sponsor's protocol ID
- TNG260-C101
- Status last verified
- Jul 2026
- First submitted
- 18 Apr 2023
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of TNG260 as Single Agent and in Combination With an Anti-PD-1 Antibody In Patients With STK11 Mutated Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05887492
- Acronym / sponsor ID
- TNG260-C101
- Keywords
- STK11, KRAS wild type, LKB1
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Tango Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Phase 1 (Dose Escalation) and Phase 2 (Dose Expansion)
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: TNG260, Drug: PembrolizumabParticipants with STK11-mutant solid tumors will receive escalating doses of TNG260 in combination with pembrolizumab to estimate the MTD |
| Dose Expansion in NSCLC with KRAS Mutation | Experimental | Drug: TNG260, Drug: PembrolizumabParticipants with STK11-mutant and KRAS-mutant NSCLC (squamous and non squamous) will receive TNG260 at the identified RP2D in combination with pembrolizumab |
| Dose Expansion in NSCLC with KRAS Wild type | Experimental | Drug: TNG260, Drug: PembrolizumabParticipants with STK11-mutant and KRAS-wild type NSCLC (squamous and non-squamous) will receive TNG260 at the identified RP2D in combination with pembrolizumab |
| Dose Expansion in Advanced or Metastatic Solid Tumors | Experimental | Drug: TNG260, Drug: PembrolizumabParticipants with STK11-mutant solid tumors (including but not limited to pancreatic, endometrial, cervical, breast, and carcinoma of unknown primary) will receive TNG260 at the identified RP2D in combination with pembrolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TNG260CoREST inhibitor, administered orally | Drug | Dose Escalation, Dose Expansion in Advanced or Metastatic Solid Tumors, Dose Expansion in NSCLC with KRAS Mutation, Dose Expansion in NSCLC with KRAS Wild type |
| PembrolizumabAlso: KeytrudaPembrolizumab, an anti-PD-1 antibody, administered intravenously | Drug | Dose Escalation, Dose Expansion in Advanced or Metastatic Solid Tumors, Dose Expansion in NSCLC with KRAS Mutation, Dose Expansion in NSCLC with KRAS Wild type |
Primary outcome
Determine the MTD and RP2D(s) (Phase 1 only)
Time frame: 42 days
To determine the MTD and RP2D(s) of TNG260 when administered in combination with pembrolizumab
Measure antitumor activity using RECIST 1.1 (Phase 2 only)
Time frame: 12 weeks
To assess antineoplastic activity of TNG260 when administered in combination with pembrolizumab in participants with locally advanced unresectable or metastatic STK11-mutated solid tumors by measuring ORR, DOR, and PFS by RECIST 1.1
8 secondary outcomes
Measure antitumor evidence of TNG260 + pembrolizumab antineoplastic activity by RECIST 1.1 (Phase 1 only)
Time frame: 12 weeks
Characterize Area Under the Curve (AUC) of TNG260
Time frame: 37 days
Characterize the time to achieve Time to Maximal Concentration (Tmax) of TNG260
Time frame: 37 days
Characterize Maximum Observed Plasma Concentration (Cmax) of TNG260
Time frame: 37 days
Characterize Terminal Half-life (T1/2) of TNG260
Time frame: 37 days
Characterize pembrolizumab concentrations when administered with TNG260
Time frame: 43 days
Safety and tolerability of TNG260 by CTCAE 5.0
Time frame: 42 days
To measure changes in histone acetylation when administered with TNG260
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Crystal, MD, PhD study director
Tango Therapeutics, Inc.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TNG260 and Pembrolizumab in people with Non Small Cell Lung Cancer and Solid Tumors, Adult, run by Tango Therapeutics, Inc. at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the MTD and RP2D(s) (Phase 1 only) (time frame: 42 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.