What is the mechanism of action of this treatment?

Common treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, while targeted therapies, such as selective PRMT5 inhibitors like TNG908, inhibit specific proteins involved in tumor growth and survival. Immunotherapy boosts the body's immune system to recognize and destroy cancer cells. Understanding these mechanisms is crucial for solid tumor patients as it helps in selecting the most effective treatment, managing side effects, and improving overall outcomes.

What side effects are associated with this type of intervention?

Common treatments for solid tumors, including those similar to the selective PRMT5 inhibitor TNG908, often exhibit side effects such as fatigue, nausea, anemia, and gastrointestinal issues like diarrhea and vomiting. Other frequently reported adverse events include generalized edema, pruritis, decreased appetite, and rash. These side effects are generally manageable and do not typically lead to treatment discontinuation.

What prior FDA approvals exist?

The FDA has approved several targeted therapies for the treatment of solid tumors. For instance, erdafitinib is approved for FGFR-altered advanced cholangiocarcinoma, and infigratinib is another FGFR inhibitor approved for similar indications. These drugs, like the selective PRMT5 inhibitor TNG908, target specific molecular pathways involved in tumor growth. Additionally, therapies such as trastuzumab for HER2-positive breast cancer and cabozantinib for medullary thyroid cancer are examples of targeted treatments that have received FDA approval for solid tumors.

What other types of research exist?

Promising alternatives to TNG908 for solid tumors include: 1) Niraparib, a PARP inhibitor showing efficacy in BRCA-mutant and wild-type intracranial triple-negative breast cancer. 2) Cabozantinib, a tyrosine kinase inhibitor effective in medullary thyroid cancer. 3) Lutetium-177-PSMA-617, a radioligand therapy for metastatic castration-resistant prostate cancer. These treatments have demonstrated significant clinical benefits in various solid tumors and may be considered as alternatives.

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PRMT5 Inhibitor

TNG908 for Solid Tumors

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

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

Documented bi-allelic (homozygous) deletion of MTAP in a tumor detected by next- generation sequencing or absence of MTAP protein in a tumor detected by IHC

Must not have

Patient is unwilling or unable to comply with the scheduled visits, drug administration plan, laboratory tests, biopsy, or other study procedures and study restrictions

Active prior or concurrent malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing TNG908, an oral drug, in patients with advanced or metastatic solid tumors that have an MTAP deletion. The drug works by blocking a protein that helps these specific cancer cells grow. The study will see if this treatment can help slow down or stop the cancer.

Who is the study for?

This trial is for adults (18+) with advanced or metastatic solid tumors that lack the MTAP protein, confirmed by specific tests. Participants must have tried standard treatments if available, be in fairly good health with a performance score of 0 to 1 or ≥70, and have functioning major organs. Pregnant women and those with significant medical conditions, allergies to TNG908, uncontrolled illnesses affecting study compliance, active infections requiring therapy, other cancers, certain heart diseases or HIV not meeting specific criteria are excluded.

What is being tested?

TNG908 is being tested on patients with MTAP-deleted solid tumors. It's an oral drug designed to inhibit PRMT5. The trial has two parts: dose escalation to find the safe amount people can take without too many side effects and dose expansion focusing on how well it works in particular tumor types.

What are the potential side effects?

Since this is a first-in-human study for TNG908, detailed side effects aren't listed yet. However, participants will be closely monitored for any adverse reactions due to the newness of this treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My tumor lacks the MTAP gene or protein.

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I am fully active or able to carry out light work.

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I am fully active or able to carry out light work.

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My cancer is advanced, cannot be surgically removed, or has returned.

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My cancer is advanced, cannot be surgically removed, or has returned.

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My tumor lacks the MTAP gene or protein.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am willing and able to follow the study's schedule and procedures.

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I have another cancer besides the one being treated.

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I am currently on medication for an infection.

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My cancer has spread to my brain and is causing worsening symptoms.

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I have heart problems that affect my daily life.

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I have an active liver disease.

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I do not have any illnesses that would stop me from following the study's requirements.

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I am currently pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 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 2

Secondary study objectives

Phase 1

Phase 1 and 2

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 TNG908 at the identified RP2D

Group II: Dose Expansion in SarcomaExperimental Treatment1 Intervention

Participants with MTAP-deleted sarcoma (soft tissue and bone) will receive TNG908 at the identified RP2D

Group III: Dose Expansion in Pancreatic Ductal AdenocarcinomaExperimental Treatment1 Intervention

Participants with MTAP-deleted pancreatic ductal adenocarcinoma will receive TNG908 at the identified RP2D

Group IV: Dose Expansion in NSCLCExperimental Treatment1 Intervention

Participants with MTAP-deleted NSCLC (squamous and non squamous) will receive TNG908 at the identified RP2D

Group V: Dose Expansion in MesotheliomaExperimental Treatment1 Intervention

Participants with MTAP-deleted mesothelioma will receive TNG908 at the identified RP2D

Group VI: Dose Expansion in GlioblastomaExperimental Treatment1 Intervention

Participants with MTAP-deleted relapsed/refractory glioblastoma will receive TNG908 at the identified RP2D

Group VII: Dose EscalationExperimental Treatment1 Intervention

Participants with MTAP-deleted solid tumors will receive escalating doses of TNG908 to estimate the MTD

0 / 15Eligibility criteria met

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 chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, while targeted therapies, such as selective PRMT5 inhibitors like TNG908, inhibit specific proteins involved in tumor growth and survival. Immunotherapy boosts the body's immune system to recognize and destroy cancer cells. Understanding these mechanisms is crucial for solid tumor patients as it helps in selecting the most effective treatment, managing side effects, and improving overall outcomes.

Breast Cancer Resistance to Cyclin-Dependent Kinases 4/6 Inhibitors: Intricacy of the Molecular Mechanisms.Predictive and prognostic biomarkers with therapeutic targets in colorectal cancer: A 2021 update on current development, evidence, and recommendation.Applied Precision Cancer Medicine in Neuro-Oncology.