QLS31905 / Qilu Pharma - LARVOL DELTA

A Study to Compare QLS31905 and Chemotherapy With Placebo and Chemotherapy in Participants With Pancreatic Cancer (clinicaltrials.gov) - P3 | N=602 | Recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Pancreatic Cancer • Solid Tumor

China‑based Qilu Pharmaceutical Co., Ltd. announced that it has opened enrollment for its first‑in‑class QLS31905 Phase III study, the company’s registration‑enabling trial for the first‑line treatment of Claudin18.2‑positive advanced pancreatic cancer (flcube.com)

Enrollment open • Pancreatic Cancer

Combination of QLS31905 and Chemotherapy ± QL2107 in Patients With CLDN18.2-positive Advanced Biliary Tract Cancer (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

New P2 trial • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor

A Study to Compare QLS31905 and Chemotherapy With Placebo and Chemotherapy in Participants With Pancreatic Cancer (clinicaltrials.gov) - P3 | N=602 | Not yet recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

New P3 trial • Oncology • Pancreatic Cancer • Solid Tumor

Safety and efficacy of QLS31905 in patients with advanced solid tumors: Updated data from phase 1 study. (ASCO 2025) - P1 | "QLS31905 was safe and tolerable, and showed encouraging efficacy in Claudin18.2-positive pts with gastrointestinal tumors. QLS31905 is worthy of further exploration in combined therapy in phase 2 trials."

Clinical • Metastases • P1 data • Anemia • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pain • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CLDN18

Combination of QLS31905, QL2107 and Chemotherapy as First-line Therapy in CLDN18.2-positive Unresectable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

New P2 trial • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology

Study of QLS31905 and/or QL1706 Combination With Chemotherapy in the Advanced Malignant Solid Tumors (clinicaltrials.gov) - P2 | N=360 | Not yet recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

Metastases • New P2 trial • Gastrointestinal Cancer • Oncology • Solid Tumor

Qilu Pharmaceutical Announces Results from Phase I Clinical Study for Its Novel Bispecific Antibody QLS31905 at ESMO Immuno-Oncology Congress (PRNewswire) - P1 | N=104 | NCT05278832 | Sponsor: Qilu Pharmaceutical Co., Ltd. cal | "During the ESMO Immuno-Oncology Congress...Qilu Pharmaceutical presented the latest results of the Phase I clinical trial for QLS31905 in patients with advanced solid tumors through a poster presentation....As of July 17, 2023, a total of 52 patients had been enrolled in the clinical trial, including 31 patients with gastric cancer and 12 with pancreatic cancer....Out of the 27 participants who were evaluable for efficacy, the ORR was 11.1%, and the DCR reached 63.0%. Three patients achieved partial response (PR) and exhibited moderate to high levels of Claudin18.2 expression, including two patients with pancreatic cancer and one with gallbladder cancer. Furthermore, among the 14 patients who experienced stable disease, 8 reported a reduction in the size of target lesions, and 7 showed moderate to high Claudin18.2 expression."

P1 data • Gastric Cancer • Pancreatic Cancer

A phase I clinical trial of QLS31905 in advanced solid tumors (ESMO-IO 2023) - P1 | "Of 14 pts with SD (9 in gastric cancer, 4 in PC, and 1 in duodenal cancer), eight had target lesion reduction, among whom seven showed intermediate or high CLDN18.2 expression. Conclusions QLS31905 showed safety, tolerability, and preliminary antitumor activity in advanced solid tumors."

Clinical • Metastases • P1 data • Esophageal Cancer • Gallbladder Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Small Intestinal Carcinoma • Solid Tumor • CLDN18

A Study of QLS31905 Combination Chemotherapy as First-Line Treatment in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=115 | Not yet recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

Combination therapy • Metastases • New P1/2 trial • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18

QLS31905, an anti-claudin 18.2/CD3 bispecific antibody for claudin 18.2-positive gastric cancer (AACR 2022) - "Anti-claudin 18.2 antibody IMAB362 has achieved remarkable success in the latest clinical trials. Overall, these data suggested that QLS31905 has similar efficacy to AMG 910 and is safer. QLS31905 may be an effective and clinically valuable treatment for patients with claudin 18.2-positive gastric cancer."

Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18 • CLDN8

A Study of QLS31905 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=104 | Recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

New P1 trial • Oncology • Solid Tumor