Spots Global Cancer Trial Database for Study of TJ210001 Administered in Subjects With Relapsed or Refractory Advanced Solid Tumors
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Trial Identification
Brief Title: Study of TJ210001 Administered in Subjects With Relapsed or Refractory Advanced Solid Tumors
Official Title: A Phase 1 Study of TJ210001 Administered in Subjects With Relapsed or Refractory Advanced Solid Tumors
Study ID: NCT04678921
Interventions
Study Description
Brief Summary: This is an open label, multi-center, multiple dose Phase 1 study to evaluate the safety, tolerability, MTD or MAD, PK, and PD of TJ210001 in subjects with relapsed or refractory advanced solid tumors. Beginning with Dose Level 1, TJ210001 will be given every week starting on Cycle 1 Day 1 (C1D1). The criteria for dose escalation/de-escalation will be based on the Bayesian optimal interval (BOIN) design with sequentially enrolled cohorts. The BOIN design is implemented in a simple way similar to the traditional 3+3 design but is more flexible and possesses superior operating characteristics that are comparable to those of the more complex model-based designs, such as the continual reassessment method (CRM).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Colorado Hospital - Anschutz Cancer Pavilion, Aurora, Colorado, United States
Horizon Oncology Center, Lafayette, Indiana, United States
Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
Contact Details
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