Phase 1 Trial of ATN-161 in Patients with Solid Tumors
Author Information
Author(s): Cianfrocca M E, Kimmel K A, Gallo J, Cardoso T, Brown M M, Hudes G, Lewis N, Weiner L, Lam G N, Brown S C, Shaw D E, Mazar A P, Cohen R B
Primary Institution: Fox Chase Cancer Center
Hypothesis
The study hypothesizes that ATN-161, a noncompetitive inhibitor of the fibronectin PHSRN sequence, will demonstrate safety and potential efficacy in patients with advanced solid tumors.
Conclusion
The study found that ATN-161 was well tolerated at all dose levels, but no objective clinical responses were observed.
Supporting Evidence
- All patients received from 1 to 14 cycles of treatment, totaling 86 cycles without dose-limiting toxicities.
- Approximately 1/3 of the patients manifested prolonged stable disease.
- Pharmacokinetics showed dose-independent clearance at higher doses.
Takeaway
Doctors tested a new drug called ATN-161 on 26 patients with serious tumors to see if it was safe and could help them, but it didn't work as well as hoped.
Methodology
Patients received ATN-161 as a 10-min infusion thrice weekly across eight dose cohorts, with pharmacokinetic sampling performed on Day 1.
Limitations
The study did not determine a traditional maximum tolerated dose (MTD) and lacked objective clinical responses.
Participant Demographics
The median age of participants was 64 years, with 15 males and 11 females.
Digital Object Identifier (DOI)
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