Author: Cynthia Johnson

NCT#: & Link	NCT05732831
NCT QR Code
Available as of:	October 1, 2024
Contract:	Optimal
Indication Category:	Solid Tumors
Study Sponsor:	Tango Therapeutics
Protocol #:	TNG462-C101
Title:	A Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Anti-tumor Activity of TNG462 in Patients with MTAP-deleted Advanced or Metastatic Solid Tumors
Highlight Details:	• ECOG 0-1 • Participants with locally advanced or metastatic NSCLC (squamous or non-squamous) who meet the following criteria: • a. Progressive disease after prior treatment or after following local treatment guidelines (eg, ESMO guidelines) for the standard of care (SOC) if more strict. • b. Tested for known treatable driver mutations/alterations (eg, EGFR, ALK, and ROS1) and received at least 1 SOC targeted therapy(ies) for the known alteration, if present or after failing local treatment guidelines (eg, ESMO or study guidelines) for the SOC if more strict. • Measurable disease based on RECIST v1.1 • Documented homozygous deletion of MTAP in a tumor detected by a validated NGS test, or absence of MTAP protein in a tumor detected by a validated IHC test. • Adequate organ and hematological functions • At least 1 of the following criteria for standard-of-care therapy(ies): • a. Progression or an inadequate response to an approved SOC therapy; there is no limit to the number of prior lines of therapy • b. No approved SOC therapy • c. Patient intolerant to the available SOC therapy(ies) • d. Investigator has determined that treatment with the SOC therapy is not appropriate
Biomarkers:	MTAP-deletion
Indication:	NSCLC with MTAP deletion
Phase:	2
Treatment Line:	2nd+ line
Study Drug/Test Compound:	TNG462 is a potent and selective oral small molecule inhibitor of PRMT5. TNG462 binds PRMT5 cooperatively with MTA to inhibit function. As an MTA cooperative inhibitor with selectivity for patients whose tumors are MTAP deleted, TNG462 addresses the 2 challenges of tumor selectivity and patient selection
Notes	462 more selective/potent at a lower dose then 908 462 not brain penetrant, less risk for cognitive disturbance (but not useful for brain lesions) Phase 2 IP: TNG462 QD starting dose of 200mg PO
Recruitment Status:	Just In Time – ON HOLD
Participating Institution:	Salinas Valley Health
Salinas Valley Health Clinical Research Program:	Terri Nielsen, MSJ, RN, CCRP, Clinical Research Program Manager, [email protected]

NCT#: & Link	NCT05275478
NCT QR Code
Available as of:	July 3, 2024
Contract:	Optimal
Indication Category:	Solid Tumors
Study Sponsor:	Tango Therapeutics
Protocol #:	TNG908- C101
Title:	Safety and Tolerability of TNG908 in Patients With MTAP-deleted Solid Tumors A Phase 1/2, Multi-Center,  Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Anti-tumor Activity of TNG908 in Patients with MTAP-deleted Advanced or Metastatic Solid Tumors (TNG908-C101+J13
Highlight Details:	• ECOG 0-1 • confirmed histologic or cytologic diagnosis of a locally advanced or metastatic solid tumor • Measurable disease based on RECIST, v1.1 • Documented bi-allelic (homozygous) deletion of MTAP in a tumor detected by a validated NGS test, or absence of MTAP protein in a tumor detected by a validated IHC test. • Adequate organ and hematological functions • Arm 2: Patients with locally advanced or metastatic mesothelioma, or after following • local treatment guidelines (ie, ESMO guidelines) for the standard of care if more strict • Mesothelioma, any location • Progressive disease after prior treatment • At least 1 of the following criteria for standard-of-care therapy(ies): • a. Progression or an inadequate response to an approved standard-of-care therapy; there is no limit to the number of prior lines of therapy • b. No approved standard-of-care therapy • c. Patient is intolerant to the available standard-of-care therapy(ies) • d. Investigator has determined that treatment with the standard-of-care therapy is not appropriate
Biomarkers:	MTAP-deletion
Indication:	Mesothelioma With MTAP deletion ARM 2
Phase:	2
Treatment Line:	2nd+ line
Study Drug/Test Compound:	TNG908 is a potent and selective oral  small- molecule inhibitor of PRMT5. TNG908 binds cooperatively with MTA to inhibit PRMT5 function.  Elevated levels of MTA are found in tumor cells that have lost the MTAP gene, which metabolizes MTA, conferring marked specificity of TNG908 for tumor cells that have lost MTAP but not normal cells
Notes	Phase 2 IP:TNG908 starting dose of 600mg BID PO
Recruitment Status:	Just In Time
Participating Institution:	Salinas Valley Health
Salinas Valley Health Clinical Research Program:	Terri Nielsen, MSJ, RN, CCRP, Clinical Research Program Manager, [email protected]

NCT#: & Link	NCT05275478
NCT QR Code
Available as of:	July 3, 2024
Contract:	Optimal
Indication Category:	Solid Tumors
Study Sponsor:	Tango Therapeutics
Protocol #:	TNG908- C101
Title:	Safety and Tolerability of TNG908 in Patients With MTAP-deleted Solid Tumors A Phase 1/2, Multi-Center,  Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Anti-tumor Activity of TNG908 in Patients with MTAP-deleted Advanced or Metastatic Solid Tumors (TNG908-C101+J13
Highlight Details:	• ECOG 0-1 • confirmed histologic or cytologic diagnosis of a locally advanced or metastatic solid tumor • Measurable disease based on RECIST, v1.1 • Documented bi-allelic (homozygous) deletion of MTAP in a tumor detected by a validated NGS test, or absence of MTAP protein in a tumor detected by a validated IHC test. • Adequate organ and hematological functions • Arm 1: Patients with locally advanced or metastatic NSCLC (squamous or non-squamous) • Progressive disease after prior treatment or after following local treatment guidelines (ie, ESMO guidelines) for the standard of care if more strict. • Tested for known driver mutations/alterations (e.g., EGFR, ALK, and ROS1) and received at least 1 standard- of-care targeted therapy(ies) for the known alteration, if present or after failing local treatment guidelines (ie, ESMO or trial guidelines) for the standard of care if more strict • At least 1 of the following criteria for standard-of-care therapy(ies): • a. Progression or an inadequate response to an approved standard-of-care therapy; there is no limit to the number of prior lines of therapy • b. No approved standard-of-care therapy • c. Patient is intolerant to the available standard-of-care therapy(ies) • d. Investigator has determined that treatment with the standard-of-care therapy is not appropriate
Biomarkers:	MTAP-deletion
Indication:	Lung NSCLC With MTAP deletion ARM 1
Phase:	2
Treatment Line:	2nd+ line
Study Drug/Test Compound:	TNG908 is a potent and selective oral  small- molecule inhibitor of PRMT5. TNG908 binds cooperatively with MTA to inhibit PRMT5 function.  Elevated levels of MTA are found in tumor cells that have lost the MTAP gene, which metabolizes MTA, conferring marked specificity of TNG908 for tumor cells that have lost MTAP but not normal cells
Notes	Phase 2 IP:TNG908 starting dose of 600mg BID PO
Recruitment Status:	Just In Time
Participating Institution:	Salinas Valley Health
Salinas Valley Health Clinical Research Program:	Terri Nielsen, MSJ, RN, CCRP, Clinical Research Program Manager, [email protected]