Study of TJ210001 Administered in Subjects With Relapsed or Refractory Advanced Solid Tumors
Status:
Recruiting
Trial end date:
2022-03-30
Target enrollment:
Participant gender:
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).