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Clinical Trial Summary

This is a Phase 1, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary antineoplastic activity of APS03118 administered orally in participants with RET-altered solid tumors.


Clinical Trial Description

After being informed about the study procedure and potential risks and benefits, all patients giving written informed consent will undergo a 4-week screening period to determine eligibility for study entry. The eligible participants will be enrolled using a rolling 6 dose escalation scheme to identify MTD and/or RP2D. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05653869
Study type Interventional
Source Applied Pharmaceutical Science, Inc.
Contact Jun Zhong, PhD
Phone +86 13820403158
Email zhongjun@apspharm.com
Status Recruiting
Phase Phase 1
Start date February 6, 2023
Completion date April 2025

See also
  Status Clinical Trial Phase
Completed NCT03037385 - Phase 1/2 Study of the Highly-selective RET Inhibitor, Pralsetinib (BLU-667), in Participants With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT04683250 - Study of RET Inhibitor TAS0953/HM06 in Patients With Advanced Solid Tumors With RET Gene Abnormalities Phase 1/Phase 2