[Translation] A phase I study evaluating the safety, tolerability, pharmacokinetics, and efficacy of GTA182 in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) homozygous loss of MTAP in combination with paclitaxel (albumin-bound) + gemcitabine (AG regimen) or in combination with irinotecan liposomes, fluorouracil, and leucovorin (nal-IRI + 5-FU/LV regimen).
Ia期主要目的:确定GTA182联合AG治疗方案或联合nal-IRI+5-FU/LV治疗方案的Ⅱ期推荐剂量(RP2D)。评估GTA182联合AG治疗方案或联合nal-IRI+5-FU/LV治疗方案在MTAP纯合型缺失局部晚期或转移性PDAC受试者中的安全性和耐受性。Ib期主要目的:评估在Ia期推荐的联合剂量下GTA182联合AG治疗方案或联合nal-IRI+5-FU/LV治疗方案在MTAP纯合型缺失局部晚期或转移性PDAC受试者中的安全性和耐受性;评估在Ia期推荐的联合剂量下GTA182联合AG治疗方案或联合nal-IRI+5-FU/LV治疗方案在MTAP纯合型缺失局部晚期或转移性PDAC受试者中的初步有效性。
[Translation] The primary objective of Phase Ia was to determine the Phase II recommended dose (RP2D) of GTA182 in combination with AG or in combination with nal-IRI + 5-FU/LV. The safety and tolerability of GTA182 in combination with AG or in combination with nal-IRI + 5-FU/LV in patients with homozygous deletion of MTAP-positive locally advanced or metastatic PDAC were also assessed. The primary objective of Phase Ib was to assess the safety and tolerability of GTA182 in combination with AG or in combination with nal-IRI + 5-FU/LV at the Phase Ia recommended dose in patients with homozygous deletion of MTAP-positive locally advanced or metastatic PDAC; and to assess the preliminary efficacy of GTA182 in combination with AG or in combination with nal-IRI + 5-FU/LV at the Phase Ia recommended dose in patients with homozygous deletion of MTAP-positive locally advanced or metastatic PDAC.