NCT05732831 Safety and Tolerability of TNG462 in Patients With MTAP-deleted Solid Tumors
| NCT ID | NCT05732831 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Tango Therapeutics, Inc. |
| Condition | Locally Advanced Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 225 participants |
| Start Date | 2023-05-26 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 225 participants in total. It began in 2023-05-26 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a first in human study in patients with advanced or metastatic solid tumors known to have an MTAP deletion. The first part of the study is an open-label, dose escalation and the second part is an open label dose expansion in specific MTAP-deleted tumor types. The study drug, TNG462, is a selective PRMT5 inhibitor administered orally. The study is planned to treat up to 225 participants.
Eligibility Criteria
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
Contact & Investigator
Maxim Pimpkin, MD
STUDY DIRECTOR
Tango Therapeutics, Inc.
Frequently Asked Questions
Who can join the NCT05732831 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Locally Advanced Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05732831 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05732831 currently recruiting?
Yes, NCT05732831 is actively recruiting participants. Contact the research team at clinicaltrials@tangotx.com for enrollment information.
Where is the NCT05732831 trial being conducted?
This trial is being conducted at Palo Alto, United States, Grand Junction, United States, Lake Mary, United States, Miami, United States and 11 additional locations.
Who is sponsoring the NCT05732831 clinical trial?
NCT05732831 is sponsored by Tango Therapeutics, Inc.. The principal investigator is Maxim Pimpkin, MD at Tango Therapeutics, Inc.. The trial plans to enroll 225 participants.