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Safety and Tolerability of TNG462 in Patients With MTAP-deleted Solid Tumors

ConditionLocally Advanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTango Therapeutics, Inc.

About this trial

This is a first in human study in patients with advanced or metastatic solid tumors known to have an MTAP deletion. The first part of the study is an open-label, dose escalation and the second part is an open label dose expansion in specific MTAP-deleted tumor types. The study drug, TNG462, is a selective PRMT5 inhibitor administered orally. The study is planned to treat up to 225 participants.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: ≥18 years-of-age at the time of signature of the main study ICF

Performance status: ECOG Performance Score of 0 to 1

Confirmed histologic or cytologic diagnosis of a locally advanced, metastatic, and/or unresectable solid tumor

Prior standard therapy, as available

Disqualifiers

Known allergies, hypersensitivity, or intolerance to TNG462, or its excipients or to pembrolizumab in the combination treatment arms

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

  • TNG462

    Drug

    TNG462, a selective PRMT5 inhibitor, will be administered orally

  • Pembrolizumab

    Drug

    An anti PD-1 antibody, will be administered intravenously

Treatment groups

225 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Dose EscalationExperimental treatment 2 interventions
Group B: Dose Expansion in NSCLCExperimental treatment 1 intervention
Group C: Dose Expansion in MesotheliomaExperimental treatment 1 intervention
Group D: Dose Expansion in Pancreatic Ductal AdenocarcinomaExperimental treatment 1 intervention
Group E: Dose Expansion in SarcomaExperimental treatment 1 intervention
Group F: Dose Expansion in Solid TumorsExperimental treatment 1 intervention
Group G: Dose Expansion in NSCLC in Combination with PembrolizumabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Phase 1 Maximum Tolerated Dose

To determine the maximum tolerated dose (MTD) of TNG462 when administered as a single agent and in combination with pembrolizumab

Time frame
28 days and 21 days
2

Phase 1 Dosing Schedule

To determine the dosing schedule of TNG462

Time frame
28 days
3

Phase 2 Anti-neoplastic Activity

To assess anti-neoplastic activity of TNG462 administered single agent and in combination with pembrolizumab in patients with MTAP-deleted advanced solid tumors by RECIST v1.1, iRECIST or mRECIST v1.1

Time frame
16 weeks and 18 weeks

Secondary outcomes

1

Phase 1 Anti-neoplastic Activity

To assess preliminary evidence of anti-neoplastic activity of TNG462 as a single agent and when administered in combination with pembrolizumab in patients with MTAP-deleted advanced solid tumors by RECIST v1.1, iRECIST or mRECIST v1.1

Time frame
16 weeks
2

Phase 1 and 2 Adverse Event Profile

To describe the safety and tolerability profile of TNG462 by frequency and severity of AEs

Time frame
28 days and 21 days
3

Phase 1 and 2 Concentration versus Time Curve

Measure the area under the plasma concentration versus time curve (AUC)

Time frame
16 days
4

Phase 1 and 2 Time to Achieve Maximal Plasma Concentration

Measure the time to achieve maximal plasma concentration (Tmax)

Time frame
16 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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