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PD-1/PD-L1 Inhibitor

CoREST Inhibitor + Anti-PD-1 Therapy for Solid Cancers

Phase 1 & 2

Recruiting

Research Sponsored by Tango Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 43 days

Awards & highlights

Study Summary

This trial will test a CoREST inhibitor & pembrolizumab combo to see if it's safe & effective for treating advanced solid tumors with a known STK11 mutation.

Who is the study for?

Adults with advanced solid tumors and a specific genetic change called STK11 mutation can join this trial. They should have good organ function, no current severe illnesses or other cancers, not be pregnant, and able to consent. The trial is for those who haven't had success with other treatments and are in fairly good physical condition.Check my eligibility

What is being tested?

The study tests TNG260 combined with pembrolizumab in patients whose tumors have the STK11 mutation. It aims to find the right dose for future studies, check safety and how well it's tolerated, understand how the body processes TNG260, and see if it helps against cancer.See study design

What are the potential side effects?

Possible side effects include reactions related to immune system activation by pembrolizumab (like inflammation), liver issues from TNG260, fatigue, digestive problems or infections due to lowered immunity. Side effects vary based on individual patient responses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 43 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~43 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 43 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Measure antitumor activity using RECIST 1.1 (Phase 2 only)

Secondary outcome measures

Characterize Area Under the Curve (AUC) of TNG260

Characterize Maximum Observed Plasma Concentration (Cmax) of TNG260

Characterize Terminal Half-life (T1/2) of TNG260

+5 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Dose Expansion in NSCLC with KRAS Wild typeExperimental Treatment2 Interventions

Participants with STK11-mutant and KRAS-wild type NSCLC (squamous and non-squamous) will receive TNG260 at the identified RP2D in combination with pembrolizumab

Group II: Dose Expansion in NSCLC with KRAS MutationExperimental Treatment2 Interventions

Participants with STK11-mutant and KRAS-mutant NSCLC (squamous and non squamous) will receive TNG260 at the identified RP2D in combination with pembrolizumab

Group III: Dose Expansion in Advanced or Metastatic Solid TumorsExperimental Treatment2 Interventions

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

Group IV: Dose EscalationExperimental Treatment2 Interventions

Participants with STK11-mutant solid tumors will receive escalating doses of TNG260 in combination with pembrolizumab to estimate the MTD

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Tango Therapeutics, Inc.Lead Sponsor

3 Previous Clinical Trials

491 Total Patients Enrolled

1 Trials studying Breast Cancer

140 Patients Enrolled for Breast Cancer

Adam Crystal, MD, PhDStudy DirectorTango Therapeutics, Inc.

Tiffany Wang, MDStudy DirectorTango Therapeutics, Inc.

1 Previous Clinical Trials

140 Total Patients Enrolled

1 Trials studying Breast Cancer

140 Patients Enrolled for Breast Cancer

Media Library

Pembrolizumab (PD-1/PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05887492 — Phase 1 & 2

Breast Cancer Research Study Groups: Dose Expansion in Advanced or Metastatic Solid Tumors, Dose Escalation, Dose Expansion in NSCLC with KRAS Mutation, Dose Expansion in NSCLC with KRAS Wild type

Breast Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT05887492 — Phase 1 & 2

Pembrolizumab (PD-1/PD-L1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05887492 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are actively enrolled in this research endeavor?

"Correct. Clinicaltrials.gov presents evidence that this medical research project, which was first launched on June 2nd 2023, is actively seeking enrolment. The team requires 126 people from 1 site to participate in the experiment."

Answered by AI

What is the principal aim of this research initiative?

"The primary goal of this 42-day trial is to quantify the anti-tumor effects through RECIST 1.1 (Phase 2 only). To evaluate safety and tolerability, physicians will employ CTCAE 5.0; furthermore, characterizing pembrolizumab concentrations when administered with TNG260 as well as determining the Area Under Curve (AUC) for TNG260 are both secondary objectives."

Answered by AI

Are there still openings available to join this research endeavor?

"Absolutely, based on the information posted to clinicaltrials.gov this research is still recruiting participants. This trial was first shared on June 2nd of 2023 and updated for a final time on June 7th of the same year. 126 individuals have been requested from 1 site to take part in these proceedings."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Study of TNG260 and an Anti-PD Antibody in STK11 Mutated Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05887492.