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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
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
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
6Treatment 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
Group II: Dose Expansion in SarcomaExperimental Treatment1 Intervention
Participants with MTAP-deleted sarcoma (soft tissue or bone) will receive TNG462 at the identified RP2D
Group III: Dose Expansion in Pancreatic Ductal AdenocarcinomaExperimental Treatment1 Intervention
Participants with MTAP-deleted pancreatic ductal adenocarcinoma will receive TNG462 at the identified RP2D
Group IV: Dose Expansion in NSCLCExperimental Treatment1 Intervention
Participants with MTAP-deleted NSCLC (squamous and non squamous) will receive TNG462 at the identified RP2D
Group V: Dose Expansion in MesotheliomaExperimental Treatment1 Intervention
Participants with MTAP-deleted mesothelioma will receive TNG462 at the identified RP2D
Group VI: Dose EscalationExperimental Treatment1 Intervention
Participants with MTAP-deleted solid tumors (excluding primary CNS) will receive escalating doses of TNG462 to estimate the MTD
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].
Current trends and future directions in the genetic therapy of human neoplastic disease.[Pancreatic cancer: ten years of systemic therapy].
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Who is running the clinical trial?
Tango Therapeutics, Inc.Lead Sponsor
3 Previous Clinical Trials
325 Total Patients Enrolled
Ron Weitzman, MDStudy DirectorTango Therapeutics, Inc.
2 Previous Clinical Trials
361 Total Patients Enrolled
Ellen Hooper, MDStudy DirectorTango Therapeutics, Inc.
4 Previous Clinical Trials
326 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have heart problems that affect my daily life.I have another active cancer besides the one being studied.I do not have any illnesses that would stop me from following the study's requirements.I am currently on medication for an infection.I am 18 years old or older.My tumor lacks the MTAP gene or protein.I am willing and able to follow the study's schedule and procedures.I have a digestive condition that affects how my body absorbs medication.My cancer has spread to my brain and is causing worsening symptoms.My organs are working well according to recent tests.I am fully active or can carry out light work.My liver is working well according to recent tests.I am HIV positive with a CD4+ count ≥300, undetectable viral load, and on effective treatment.I am currently pregnant or breastfeeding.My kidney function is normal according to recent tests.My cancer is advanced, has spread, and cannot be surgically removed.I have an active liver condition.I have received the standard treatment available for my condition.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Expansion in Sarcoma
- Group 2: Dose Expansion in Pancreatic Ductal Adenocarcinoma
- Group 3: Dose Expansion in Solid Tumors
- Group 4: Dose Escalation
- Group 5: Dose Expansion in NSCLC
- Group 6: Dose Expansion in Mesothelioma
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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