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
Non-Small Cell (NSCLC) Lung 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.

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