Testing TNG462 for patients with specific solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and tolerability of TNG462, a selective PRMT5 inhibitor, in patients with advanced or metastatic solid tumors that have a confirmed homozygous MTAP deletion. The study consists of two phases: an initial dose escalation phase followed by a dose expansion phase targeting specific tumor types. Participants may continue treatment with TNG462 until disease progression if they tolerate the drug well. The trial aims to enroll up to 225 participants across multiple centers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age: ≥18 years-of-age at the time of signature of the main study ICF
2. Performance status: ECOG Performance Score of 0 to 1
3. Confirmed histologic or cytologic diagnosis of a locally advanced, metastatic, and/or unresectable solid tumor
4. Prior standard therapy, as available
5. 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.
6. Adequate organ function/reserve per local labs
7. Adequate liver function per local labs
8. Adequate renal function per local labs
9. Negative serum pregnancy test result at screening
10. Written informed consent must be obtained according to local guidelines

Exclusion Criteria:

1. Known allergies, hypersensitivity, or intolerance to TNG462, or its excipients or to pembrolizumab in the combination treatment arms
2. Uncontrolled intercurrent illness that will limit compliance with the study requirements
3. Active infection requiring systemic therapy
4. Currently participating in or has planned participation in a study of another investigational agent or device
5. Impairment of GI function or disease that may significantly alter the absorption of oral TNG462
6. Active prior or concurrent malignancy.
7. Central nervous system metastases associated with progressive neurological symptoms
8. Current active liver disease from any cause
9. Known to be HIV positive, unless all of the following criteria are met:

   1. CD4+ count ≥300/μL
   2. Undetectable viral load
   3. Receiving highly active antiretroviral therapy
10. Clinically relevant cardiovascular disease
11. A female patient who is pregnant or lactating
12. Patient is unwilling or unable to comply with the scheduled visits, drug administration plan, laboratory tests, biopsy, or other study procedures and study restrictions
13. Patient has a prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the investigator's opinion, may affect the safety of the patient or impair the assessment of study results

Where it's running

• Stanford University
  Palo Alto, California, United States Recruiting
• Grand Valley Oncology
  Grand Junction, Colorado, United States Recruiting
• Sylvester Comprehensive Cancer Center
  Miami, Florida, United States Recruiting
• University Chicago Medicine
  Chicago, Illinois, United States Recruiting
• Carle Cancer Center
  Urbana, Illinois, United States Recruiting
• Midwestern Regional Medical Center, City of Hope Chicago
  Zion, Illinois, United States Recruiting

Study contacts

• Study coordinator: Maxim Pimpkin, MD
• Email: clinicaltrials@tangotx.com
• Phone: (857) 320-4899

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• 5-Azacitidine with PD-1/PD-L1 Inhibitor in PD-1/PD-L1 Refractory Tumors

  This phase I study tests different doses of 5-azacitidine combined with a PD-1/PD-L1 blocker to see if the combo can help patients whose tumors no longer respond to PD-1/PD-L1 therapy.

  Recruiting Phase 1 University of Iowa · Iowa City, Iowa · NCT07404332

• Safety and anti-tumor activity of IPN60300 in adults with advanced or metastatic solid tumors

  This trial will test whether injections of IPN60300 are safe and can help control advanced or metastatic solid tumors in adults.

  Recruiting at 10 sites Phase 1/2 Ipsen · New Haven, Connecticut and 11 other locations · NCT07213817

• YH32364 for locally advanced or metastatic EGFR‑overexpressing solid tumors

  This trial will test whether YH32364 can help adults with advanced or metastatic cancers that overexpress EGFR when other treatments haven't worked.

  Recruiting at 4 sites Phase 1/2 Yuhan Corporation · Seoul and 3 other locations · NCT06975410

• Evaluating VC004 for patients with advanced solid tumors

  This study is testing a new medication called VC004 to see if it helps people with advanced solid tumors feel better and manage their condition.

  Recruiting Phase 3 Jiangsu vcare pharmaceutical technology co., LTD · Beijing, Beijing Municipality · NCT06658353

• Imaging of immune response in advanced solid tumors

  This study is testing a new imaging method to see how well it can track the immune response in people with advanced solid tumors who are receiving PD-1 antibody treatments.

  Recruiting at 2 sites Phase 2 University Medical Center Groningen · Amsterdam and 3 other locations · NCT06534190

• Evaluating NVL-330 for advanced HER2-altered lung cancer

  This study is testing a new treatment called NVL-330 to see if it can safely help people with advanced lung cancer that has changes in the HER2 gene.

  Recruiting at 20 sites Phase 1 Nuvalent Inc. · Irvine, California and 20 other locations · NCT06521554

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.