Study of Eryaspase in Combination With Chemotherapy Versus Chemotherapy Alone as 2nd-Line Treatment in PAC

Phase 3 Completed 512 enrolled ERYtech Pharma

RandomizedParallel-groupOpen-labelTreatment

Summary

This is an open-label, multicenter, randomized, Phase 3 study in patients with ductal adenocarcinoma of the pancreas who have failed only one prior line of systemic anti-cancer therapy for advanced pancreatic cancer and have measurable disease.

Timeline

Start: 2018-09-15
Primary completion: 2021-08-30
Completion: 2022-01-18

Publications

Hammel P, Metges JP, Macarulla Mercade T, Garcia-Carbonero R, Bouche O, Portales F, Pazo Cid RA, Mineur L, Cubillo Gracian A, Trouilloud I, Guimbaud R, Tougeron D, Reina JJ, Feliu J, Sauri T, Fountzilas C, Lecomte T, Molin Y, Ponz-Sarvise M, Forget F, Berardi R, Van Cutsem E, Gelsomino F, Tournigand C, Bockorny B, Bachet JB, Marin Vera M, Cuyle PJ, Wasan H, Noel M, Van Laethem JL, Kay R, Youssoufian H, El-Hariry I, Hidalgo M. TRYBECA-1: A Randomized Phase III Study of Eryaspase Combined With Chemotherapy Versus Chemotherapy as Second-Line Treatment in Patients With Advanced Pancreatic Adenocarcinoma. J Clin Oncol. 2025 Dec 10;43(35):3714-3727. doi: 10.1200/JCO-25-00872. Epub 2025 Nov 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GRASPA	Protein / enzyme biologic	100 iu/kg	Intravenous
Background	Gemcitabine	Small molecule	1000 mg/m2	Intravenous
Background	Irinotecan	Small molecule	50 mg/m2	Intravenous
Background	Irinotecan	Small molecule	70 mg/m2	Intravenous
Background	Irinotecan	Small molecule	180 mg/m2	Intravenous
Background	Leucovorin	Small molecule	400 mg/m2	Intravenous
Background	Paclitaxel	Small molecule	125 mg/m2	Intravenous
Background	fluorouracil	Small molecule	2400 mg/m2	Intravenous

Study of Eryaspase in Combination With Chemotherapy Versus Chemotherapy Alone as 2nd-Line Treatment in PAC

Summary

Timeline

Publications

Drugs

Indications