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TNG462 for Solid Cancers
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.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- 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
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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