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Study of TNG260 and an Anti-PD Antibody in STK11 Mutated Solid Tumors

ConditionsNon Small Cell Lung CancerSolid Tumors, AdultLung CancerLung Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTango Therapeutics, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • TNG260

    Drug

    CoREST inhibitor, administered orally

  • Pembrolizumab

    Drug

    Pembrolizumab, an anti-PD-1 antibody, administered intravenously

Treatment groups

126 Participants
are divided into 4 treatment groups
Group A: Dose EscalationExperimental treatment 2 interventions
Group B: Dose Expansion in NSCLC with KRAS MutationExperimental treatment 2 interventions
Group C: Dose Expansion in NSCLC with KRAS Wild typeExperimental treatment 2 interventions
Group D: Dose Expansion in Advanced or Metastatic Solid TumorsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Determine the MTD and RP2D(s) (Phase 1 only)

To determine the MTD and RP2D(s) of TNG260 when administered in combination with pembrolizumab

Time frame
42 days
2

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

Time frame
12 weeks

Secondary outcomes

1

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

Time frame
12 weeks
2

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

Time frame
37 days
3

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

Time frame
37 days
4

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

Time frame
37 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tango Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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