What side effects are associated with this type of intervention?

Common treatments for breast cancer, particularly immune checkpoint inhibitors like pembrolizumab, can cause immune-related adverse events such as fatigue, rash, diarrhea, and thyroid dysfunction. Severe side effects may include pneumonitis, hepatitis, colitis, and nephritis. Targeted therapies like CoREST inhibitors, though still under investigation, may cause fatigue, nausea, and hematologic toxicities. Combining these therapies may increase the risk of overlapping toxicities, requiring careful monitoring.

What prior FDA approvals exist?

Pembrolizumab, an immune checkpoint inhibitor, has been approved by the FDA for the treatment of triple-negative breast cancer (TNBC) with PD-L1 expression. This approval is based on its ability to enhance the immune system's response against cancer cells. While CoREST inhibitors like TNG260 are still under investigation and may not yet have specific FDA approvals for breast cancer, the focus on immune checkpoint inhibitors like Pembrolizumab highlights the ongoing advancements in immunotherapy for breast cancer treatment.

What other types of research exist?

Promising novel alternatives for breast cancer treatment in 2024 include the combination of fulvestrant plus everolimus for hormone-receptor positive, HER2-negative disease, as demonstrated in the PrEGOC 0102 trial. Additionally, the pan-PI3K inhibitor buparlisib in combination with fulvestrant has shown some activity. For triple-negative breast cancer (TNBC), the addition of pembrolizumab to chemotherapy has shown significant improvement in progression-free survival in the KEYNOTE-355 study.

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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

No Placebo-Only Group

Summary

This trial is testing a new drug, TNG260, combined with an existing cancer treatment, pembrolizumab, in patients with advanced solid tumors that have an STK11 mutation. TNG260 aims to block proteins that help cancer grow, while pembrolizumab boosts the immune system to fight the cancer. Pembrolizumab has been shown to be an effective and safe therapeutic option for various advanced cancers, including endometrial cancer and melanoma. The study will determine the best dose, safety, and effectiveness of this combination.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Measure antitumor activity using RECIST 1.1 (Phase 2 only)

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 3

~3130

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for breast cancer include CoREST inhibitors and immune checkpoint inhibitors. CoREST inhibitors work by disrupting the CoREST complex, which plays a role in gene repression, potentially altering gene expression to inhibit tumor growth. Immune checkpoint inhibitors like Pembrolizumab block proteins such as PD-1, which cancer cells use to evade the immune system, thereby boosting the body's immune response to attack cancer cells. These mechanisms are important for breast cancer patients as they offer targeted approaches to treatment, potentially leading to better control of the disease and improved survival rates.

Precision Breast Cancer Medicine: Early Stage Triple Negative Breast Cancer-A Review of Molecular Characterisation, Therapeutic Targets and Future Trends.