QL1203 / Qilu Pharma - LARVOL DELTA

A Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of QLC1101 in Combination With Other Therapies in the Treatment of Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation (clinicaltrials.gov) - P1/2 | N=240 | Not yet recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

New P1/2 trial • Solid Tumor • KRAS

QL1203 vs placebo plus mFOLFOX6 as first-line therapy in RAS wild-type, metastatic colorectal cancer (mCRC): Interim analysis (IA) of a multicenter, randomized, double-blinded, parallel, phase 3 trial. (ASCO-GI 2025) - P3 | "Funded by No funding sources reported Clinical Trial Registration Number: NCT04233151 Background: Panitumumab plus FOLFOX or FOLFIRI has been approved as the first-line therapy for RAS wild-type mCRC... QL1203 demonstrated significantly improved PFS versus placebo and higher ORR."

Clinical • Metastases • P3 data • P3 data: top line • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF

QL1203 In Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy and Safety (clinicaltrials.gov) - P3 | N=590 | Recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting | Trial completion date: Mar 2023 ➔ Jul 2025 | Trial primary completion date: Oct 2022 ➔ Dec 2024

Combination therapy • Enrollment open • Metastases • Trial completion date • Trial primary completion date • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

WX-0593 combined with an epithelial growth factor receptor (EGFR) monoclonal antibody in the treatment of xenograft tumors carrying triple EGFR mutations. (PubMed, Ann Transl Med) - "To evaluate the safety and therapeutic efficacy of WX-0593, a newly developed potent anaplastic lymphoma kinase (ALK) inhibitor, in combination with an epithelial growth factor receptor (EGFR) monoclonal antibody (QL1203 or Vectibix) for the treatment of xenograft tumors carrying mutant EGFR and osimertinib-resistant mutations (EGFR/T790M/C797S). WX-0593 exhibited a synergetic effect with an EGFR monoclonal antibody on osimertinib-resistant EGFR-mutant non-small cell lung cancer (NSCLC) both in vitro and in vivo. Their combination showed potent antitumor efficacy and an acceptable safety profile, which may be a promising strategy for the treatment of patients with EGFR triple-mutant NSCLC resistant to osimertinib."

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Comparing the Pharmacokinetic and Safety of QL1203 and Vectibix® in Healthy Males. (clinicaltrials.gov) - P1; N=94; Recruiting; Sponsor: Qilu Pharmaceutical Co., Ltd.

Clinical • New P1 trial

QL1203 In Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy and Safety (clinicaltrials.gov) - P3; N=590; Not yet recruiting; Sponsor: Qilu Pharmaceutical Co., Ltd.

Clinical • Combination therapy • New P3 trial