Multi-center Phase 1 study of Triapine in Combination with [177Lu]Lutetium-Dotatate in Patients with Well-Differentiated Neuroendocrine Tumors (ETCTN 10388).

Authors

Aman Chauhan, Heidi L Weiss, Charles Kunos, Rani Jayswal, Bhavana Konda, Heloisa P Soares, Daneng Li, Thorvardur R Halfdanarson, Mary F Mulcahy, Heather A Jacene, Aman Khurana, Rakhi Modak, Donglin Yan, Jan H Beumer, Susan M Christner, Peter I-Fan Wu, Biswajit Das, Larry V Rubinstein, Steven D Gore, S Percy Ivy, Elise C Kohn, William E Carson, Lowell B Anthony, Susanne M Arnold

Published in

Clinical cancer research : an official journal of the American Association for Cancer Research. Jul 28, 2026. Epub Jul 28, 2026.

Abstract

Next generation of Theranostics studies are looking at novel combinations with radiation sensitizers to enhance PRRT's efficacy. Here, we present safety and efficacy data from a multi-center phase 1 study of a [¹⁷⁷Lu]lutetium-dotatate -triapine combination in patients with GEP-NETs.
The study consisted of two phases (dose escalation and expansion) administering the recommended phase 2 doses (RP2D) for the two agents. All patients received 200 mCi of [¹⁷⁷Lu]lutetium-dotatate on day 1 of four 8-week cycles, in combination with oral triapine administered at assigned dose levels (100 mg, 150 mg or 200mg) from days 1 to 14 of each cycle.
A total of 31 (A: 15 ; B: 16 ) patients received treatment. Nine patients experienced dose-limiting toxicities; Grade 3 anemia (n=1), Grade 5 cardiac arrest (n=1), and Grade 4 neutropenia (n=7). Based on the overall safety and pharmacokinetics data, a [¹⁷⁷Lu]lutetium-dotatate (200 mCi) plus triapine (150 mg) dose was selected as the RP2D for the expansion phase. Grade ≥3 treatment related adverse events were observed in 77% patients: anemia (23%), nausea and vomiting (3% ), lymphopenia ( 58%), neutropenia ( 35%) and leukopenia ( 39%). The majority of cytopenias were transient and resolved within two weeks. Among the 28 evaluable patients, the objective response rate (ORR) was 21.4% and the median progression-free survival (mPFS) has not been reached (median follow-up period: 23.7 months).
The combination of [¹⁷⁷Lu]lutetium-dotatate (200 mCi) and oral triapine (150 mg D1-14) was well tolerated and demonstrated preliminary activity in patients with well-differentiated GEP-NETs. (NCT04234568).

PMID:
42518206
Bibliographic data and abstract were imported from PubMed on 28 Jul 2026.

Read full publication at:
Please sign in to see all details.

Stats

1-terrible, 9-excellent. How would you rate this publication? Sign in in to submit your rating.

Post a comment

You need to be signed in to post comments. You can sign in here.

Comments

There are no comments yet.