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Title
Status

 

MYTHIC (RP-6306) - Phase 1 Study of the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of RP-6306 in Patients With Advanced Solid Tumors (MYTHIC Study)

Closed

MYTHIC (RP-6306) - Phase 1 Study of the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of RP-6306 in Patients With Advanced Solid Tumors (MYTHIC Study)

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DiagnosisAdvanced Solid TumorStudy StatusClosed
PhaseI
Age12 years and olderRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationRP-6306 (PKMYT1 Inhibitor): Oral
Last Posted Update2024-01-19
ClinicalTrials.gov #NCT04855656
International Sponsor
Repare Therapeutics
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Daniel Morgenstern
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

(via: https://www.mskcc.org/cancer-care/clinical-trials/21-303)

The purpose of this study is to find the highest dose of the investigational drug RP-6306 that can be used in advanced solid tumors containing certain genetic changes and which have come back or continued to grow despite prior treatment. 

RP-6306 blocks the protein PKMY1, which plays a major role in the survival and growth of cancers with the genetic changes being studied in this clinical trial. RP-6306 is taken orally (by mouth).

Inclusion Criteria

(via: https://www.mskcc.org/cancer-care/clinical-trials/21-303)

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a locally advanced or metastatic solid tumor that has come back or continued to grow despite prior treatment
  • Participants’ tumors must contain a mutation in the FBXW7 or PPP2R1A genes or extra copies of the CCNE1 gene
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours
  • This study is for people age 12 and older

Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.