A Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of Orally Administered SM08502 Combined With Hormonal Therapy or Chemotherapy in Subjects With Advanced Solid Tumors
Stopped early · Phase 1
Conditions studied: Castration-resistant Prostate Cancer, Non-small Cell Lung Cancer, Colorectal Cancer
In brief
This study is an open-label, multi-center, dose-escalation, dose expansion study in adult subjects with advanced solid tumors. The study will evaluate the safety, tolerability, PK, and preliminary anti-tumor efficacy of SM08502 administered orally (PO), once daily (QD), following a 5 days on 2 days off treatment schedule in combination with chemotherapy or hormonal therapy. Alternative dosing schedules may be explored in Part 1 if necessary. The recommended Part 2 dose and schedule for each combination will then be further evaluated in the Part 2 expansion. Dosing will occur in 21- or 28-day cycles (depending on the combination partner) and treatment with SM08502 will continue within each subject unless treatment is discontinued due to toxicity, disease progression, initiation of a new anti-neoplastic therapy, withdrawal of consent, the Sponsor terminates the study, or the subject no longer meets retreatment criteria.
Key facts
- Study ID
- NCT05084859
- Run by
- Biosplice Therapeutics, Inc.
- People needed
- 30
- Starts
- 2021-11-03
- Expected to finish
- 2022-10-20
- Last updated by the study team
- 2024-08-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- The University of Arizona Cancer Center (UACC) - North Campus — Tucson, Arizona, United States
- University of Colorado, Anschutz — Aurora, Colorado, United States
- University of Colorado — Aurora, Colorado, United States
- Maine Center for Cancer Medicine — Scarborough, Maine, United States
- START Midwest — Grand Rapids, Michigan, United States
- Memorial Sloan-Kettering Cancer Center — New York, New York, United States
- Duke Cancer Institute (DCI) - Duke Cancer Center — Durham, North Carolina, United States
- The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital, LLC — Cincinnati, Ohio, United States
- Vanderbilt University — Nashville, Tennessee, United States
- Texas Oncology — Fort Worth, Texas, United States
- Texas Oncology-San Antonio Northeast — San Antonio, Texas, United States
- UT Health San Antonio - Mays Cancer Center - Institute for Drug Development — San Antonio, Texas, United States
- START Mountain Region — West Valley City, Utah, United States
- Virginia Cancer Specialists, PC — Fairfax, Virginia, United States
- Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care — Roanoke, Virginia, United States
- Seattle Cancer Care Alliance (SCCA) — Seattle, Washington, United States
- Chris O'Brien Lifehouse — Camperdown, Australia
- Saint Vincent's Hospital — Darlinghurst, Australia
- Icon Cancer Care-South Brisbane — South Brisbane, Australia
- The Queen Elizabeth Hospital (TQEH) — Woodville South, Australia
Full record on ClinicalTrials.gov
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