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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
Study Summary
This trial tests a drug to treat advanced/metastatic cancers with a certain gene deletion. It's given orally & will treat up to 159 people.
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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1 Dosing Schedule
Phase 1 Maximum Tolerated Dose
Phase 2 Anti-neoplastic Activity
Secondary outcome measures
Phase 1 Anti-neoplastic Activity
Phase 1 and 2 Adverse Event Profile
Phase 1 and 2 Concentration versus Time Curve
+6 moreTrial 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
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Who is running the clinical trial?
Tango Therapeutics, Inc.Lead Sponsor
3 Previous Clinical Trials
458 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment period for this study still open?
"Absolutely. Clinicaltrials.gov reveals that this research is still actively seeking participants, having been first posted on May 26th 2023 and updated most recently on June 7th of the same year. The trial requires 159 patients to be enrolled at a single site."
Answered by AI
To what extent has this research been embraced by the public?
"Verified. The details hosted on clinicaltrials.gov indicate that this medical research, which was initially posted on May 26th 2023, is actively seeking participants. 159 subjects must be recruited from a sole study site."
Answered by AI
What purpose does this research endeavor aim to achieve?
"The main objective that will be measured over the course of 28 days is Phase 1 Dosing Schedule. Additionally, Maximum Observed Plasma Concentration (Cmax), Total Plasma Clearance (CL/F) and Volume of Distribution when dosed orally (Vz/F) are secondary objectives to be evaluated."
Answered by AI
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