A Phase 1a/1b First-in-human Multicenter Study to Assess the Efficacy and Safety of RGT-61159 for Treatment of Patients with Relapsed/Refractory Adenoid Cystic Carcinoma (ACC) or Colorectal Carcinoma (CRC)
Brief description of study
This study will test the potential tumor-fighting effects of a daily medication called RGT-61159 for patients with advanced ACC or CRC, two types of cancer, when other treatments have stopped working or aren’t suitable. Patients will take RGT-61159 in 21-day cycles, starting at a dose of 6 mg. The study uses a dose-escalation plan, meaning patients will move to higher doses until the highest safe dose, or recommended Phase 2 dose (RP2D), is found. If certain side effects appear, more patients may be added at the current dose level to carefully check for safety and find the best dose for future studies.
Clinical Study Identifier: s24-00462
ClinicalTrials.gov Identifier: NCT06462183
Principal Investigator:
Zujun Li.
Other Investigators:
Nila Theresa De La Rosa,
Anam Qureshi,
Elaine Shum,
Michael Persky,
Scot Niglio,
Colin Hill,
Kirby Rodriguez,
Janice Mehnert,
Maya Dimitrova,
Elise M Zahriah,
Jessica Wang,
Jonathan B Kahn,
Joshua K Sabari,
Keriann M Scavone,
Nina Beri,
Paul E. Oberstein,
Caitlin Elizabeth Ryan,
Megan DiBenedetto,
Eneil De La Pena,
David R. Wise,
Salman Rafi Punekar,
Carol M Lee,
Tuyet-Phuong N Tran,
Samantha VanMaanen,
Ann M Riccobene,
Umamaheswar Duvvuri,
Kristen Spencer,
Adam S Jacobson,
Catherine M Concert,
Kathleen M Madden,
Nancy Chan,
Kenneth S Hu,
Douglas K Marks.
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