Study of ASN004 in Patients With Advanced Solid Tumors

Active:	No
Cancer Type:	Solid Tumor Unknown Primary	NCT ID:	NCT04410224
Trial Phases:	Phase I	Protocol IDs:	ASN004-101 (primary) NCI-2022-03443
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Kirilys Therapeutics Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT04410224

Summary

Participants in this study will receive ASN004 once every 3 or 4 weeks by intravenous
infusion. The ASN004 dosing schedule may be modified based on emerging data and Safety
Review Committee decision. The study will test various doses of ASN004 to find out the
highest safe dose to test in future trials.

Eligible subjects will be sequentially enrolled in cohorts at escalated doses.

Objectives

Eligible patients will be sequentially enrolled at escalating doses.

Dose escalation decisions will be based on the review of clinical safety and
pharmacokinetic (PD) and pharmacodynamics (PD) data and agreed upon by the Sponsor and
investigators.

The maximum tolerated dose (MTD) will have an estimated DLT rate of < 33%. Cohorts may be
expanded at any dose level or at the MTD for further evaluation of safety, or PK
parameters as required.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.