What side effects are associated with this type of intervention?

Common treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy often causes side effects such as nausea, fatigue, hair loss, and increased risk of infection due to bone marrow suppression. Targeted therapies, like tyrosine kinase inhibitors, can lead to side effects including diarrhea, liver toxicity, and skin rashes. Immunotherapies, such as checkpoint inhibitors, may cause immune-related adverse effects like colitis, pneumonitis, and thyroid dysfunction. For selective PRMT5 inhibitors like TNG462, specific side effects are not well-documented yet, but they may include general symptoms seen with other targeted therapies, such as fatigue, gastrointestinal disturbances, and potential hematologic toxicities.

What prior FDA approvals exist?

The FDA has approved several targeted therapies for the treatment of solid tumors, focusing on specific genetic or molecular characteristics. For instance, pembrolizumab, an immune checkpoint inhibitor, has been approved for various solid tumors with specific biomarkers such as PD-L1 expression. Additionally, the FDA has approved drugs like vemurafenib and dabrafenib for BRAF-mutated melanoma. While specific approvals for selective PRMT5 inhibitors like TNG462 are not mentioned, the trend towards personalized medicine and targeted therapies is evident in these approvals.

What other types of research exist?

Promising novel alternatives to TNG462 for solid tumor patients include ONC201, a selective DRD2 antagonist showing efficacy in gliomas, and niraparib, a PARP inhibitor demonstrating impressive results in BRCA-mutant triple-negative breast cancer models. Additionally, therapies like futibatinib, an FGFR-selective tyrosine kinase inhibitor for cholangiocarcinoma, and pembrolizumab, an immune checkpoint inhibitor for various cancers, are also noteworthy.

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PRMT5 Inhibitor

TNG462 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 28 days and 21 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new oral drug called TNG462 in patients with advanced or metastatic solid tumors that have an MTAP deletion. The drug works by blocking a protein that helps these cancer cells grow. The goal is to see if TNG462 can stop the cancer from growing and spreading.

Who is the study for?

This trial is for adults with advanced solid tumors that have an MTAP deletion. They should have tried standard treatments, be in fairly good health (ECOG score of 0-1), and have no major organ issues. Pregnant or breastfeeding women, those with allergies to TNG462, uncontrolled illnesses, other cancer treatments ongoing or planned, significant GI absorption issues, active serious infections or liver disease are excluded.

What is being tested?

The study tests TNG462's safety and how well patients tolerate it. It's a first-in-human study with two parts: dose escalation to find the safe amount to give people and then dose expansion focusing on specific tumor types. Up to 159 participants will take this oral PRMT5 inhibitor.

What are the potential side effects?

Since this is a first-in-human study for TNG462, detailed side effects aren't listed yet but may include typical reactions related to new cancer drugs such as nausea, fatigue, allergic reactions or changes in blood counts.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days and 21 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days and 21 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days and 21 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

Phase 1 Dosing Schedule

Phase 1 Maximum Tolerated Dose

Phase 2 Anti-neoplastic Activity

Secondary study objectives

Phase 1 Anti-neoplastic Activity

Phase 1 and 2 Adverse Event Profile

Phase 1 and 2 Concentration versus Time Curve

+6 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

7Treatment groups

Experimental Treatment

Group I: Dose Expansion in Solid TumorsExperimental Treatment1 Intervention

Participants with other MTAP-deleted solid tumors will receive TNG462 at the identified RP2D(s)

Group II: Dose Expansion in SarcomaExperimental Treatment1 Intervention

Participants with MTAP-deleted sarcoma (soft tissue or bone) will receive TNG462 at the identified RP2D(s)

Group III: Dose Expansion in Pancreatic Ductal AdenocarcinomaExperimental Treatment1 Intervention

Participants with MTAP-deleted pancreatic ductal adenocarcinoma will receive TNG462 at the identified RP2D(s)

Group IV: Dose Expansion in NSCLC in Combination with PembrolizumabExperimental Treatment2 Interventions

Participants NSCLC (squamous and non squamous) MTAP-deleted solid tumors will receive TNG462 at the identified RP2D(s)

Group V: Dose Expansion in NSCLCExperimental Treatment1 Intervention

Participants with MTAP-deleted NSCLC (squamous and non squamous) will receive TNG462 at the identified RP2D(s)

Group VI: Dose Expansion in MesotheliomaExperimental Treatment1 Intervention

Participants with MTAP-deleted mesothelioma will receive TNG462 at the identified RP2D(s)

Group VII: Dose EscalationExperimental Treatment2 Interventions

Participants with MTAP-deleted solid tumors (excluding primary CNS) will receive escalating doses of TNG462 single agent and 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 solid tumors include targeted therapies, immunotherapies, and chemotherapies. Targeted therapies, such as tyrosine kinase inhibitors, work by blocking specific molecules involved in tumor growth and progression. Immunotherapies, like checkpoint inhibitors, enhance the body's immune response against cancer cells. Chemotherapies generally kill rapidly dividing cells, including cancer cells, but can also affect normal cells. TNG462, a selective PRMT5 inhibitor, targets the PRMT5 enzyme, which is involved in gene expression and tumor growth. Understanding these mechanisms helps in selecting the most effective treatment, minimizing side effects, and improving outcomes for patients with solid tumors.

Current trends and future directions in the genetic therapy of human neoplastic disease.[Pancreatic cancer: ten years of systemic therapy].