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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights
Study Summary
This trial is testing a new drug, TNG908, to see if it can shrink tumors in people with advanced or metastatic solid tumors.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
My tumor lacks the MTAP gene or protein.
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 2
Secondary outcome measures
Phase 1
Phase 1 and 2
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
Find a Location
Who is running the clinical trial?
Tango Therapeutics, Inc.Lead Sponsor
3 Previous Clinical Trials
425 Total Patients Enrolled
Ron Weitzman, MDStudy DirectorTango Therapeutics, Inc.
2 Previous Clinical Trials
328 Total Patients Enrolled
M Rudoltz, MDStudy DirectorTango Therapeutics, Inc.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing and able to follow the study's schedule and procedures.I am 18 years old or older.My tumor lacks the MTAP gene or protein.I have another cancer besides the one being treated.I am fully active or able to carry out light work.My kidney function is normal according to recent tests.I am fully active or able to carry out light work.I am currently on medication for an infection.My cancer has spread to my brain and is causing worsening symptoms.I have heart problems that affect my daily life.I am HIV positive with a CD4+ count ≥300, undetectable viral load, and on effective treatment.I have received the standard treatment available for my condition.My cancer is advanced, cannot be surgically removed, or has returned.I have an active liver disease.My liver is working well according to recent tests.I have a digestive condition that affects how my body absorbs medication.My cancer is advanced, cannot be surgically removed, or has returned.My tumor lacks the MTAP gene or protein.My organs are working well according to recent tests.I do not have any illnesses that would stop me from following the study's requirements.I am currently pregnant or breastfeeding.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Expansion in solid tumors
- Group 2: Dose Expansion in Sarcoma
- Group 3: Dose Expansion in Glioblastoma
- Group 4: Dose Expansion in Mesothelioma
- Group 5: Dose Expansion in Pancreatic Ductal Adenocarcinoma
- Group 6: Dose Escalation
- Group 7: Dose Expansion in NSCLC
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.
Could you tell me how many hospitals are included in this research project?
"NEXT Oncology in San Antonio, Texas, Dana Farber Cancer Institute in Houston, Virginia, and The University of Texas MD Anderson Cancer Center in Fairfax, Tennessee are a few of the clinical trial sites that are enrolling patients for this study. There are also 6 other locations."
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