First in Human Study of SIM0610 in Solid Tumors

This is a multicenter, open-label, first-in-human (FIH) study to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic profile, and preliminary antitumor activity of SIM0610 in subjects with locally advanced/metastatic solid tumors. Accelerated titration (ATD) and Bayesian optimal interval design (BOIN) will be used to guide dose escalation in part1, the preliminary anti-tumor effect of SIM0610 will to be further evaluated in part 2.

Trial Details

NCT ID
NCT07348211
Phase
PHASE1
Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
Status
RECRUITING
Cancer Type
Colon Cancer Colorectal Cancer
Interventions
  • SIM0610 for Injection
Locations (sample)
  • Chongqing, Chongqing Municipality, China|29.56026,106.55771
  • Harbin, Heilongjiang, China|45.75,126.65
  • Shenyang, Liaoning, China|41.79222,123.43278
  • Jinan, Shandong, China|36.66833,116.99722
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806

Key Eligibility Criteria

  • Voluntarily participate and sign the informed consent form
  • At least 18 years old, male or female
  • Subjects with locally advanced/metastatic solid tumors confirmed by histology and/or cytology;
  • Subjects in Part 1 should have at least one tumor lesion evaluable by RECIST v1.1 criteria, and subjects in Part 2 should have at least one measura…

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Colon Cancer Colorectal Cancer Trials on Trialify →