A Phase 2, Open-Label, Multicentre Study to Assess the Preliminary Efficacy and Safety of RXC004, in Patients with Advanced Pancreatic Cancer that have Progressed following Therapy with Current Standard of Care

Australian Genomic Cancer Medicine Centre Ltd t/a Omico0 个研究点目标入组 20 人开始时间: 2024年5月8日最近更新: 2024年5月13日

适应症

试验速览

暂无简介。

•1. >=18 years of age at the time of signing the informed consent
•2. Ability to give written informed consent and capable of understanding the protocol requirements
•3. At least one lesion that is measurable by RECIST 1.1 at baseline (must not be chosen for the mandatory and optional biopsies)
•4. Mandatory biopsy at screening (must not be a target lesion for RECIST 1.1), optional biopsy at C1D15
•5. Adequate organ and marrow function
•6. WOCBP and partners of participants who are WOCBP must adhere to contraception requirements
•7. Histological documentation of advanced (unresectable)/metastatic (Stage III/IV) pancreatic ductal adenocarcinoma, with documented loss of function tumour mutation in RNF43 from centralised genetic pre-screening activities or from a recognised panel in agreement with sponsor
•8. Patients must have received one prior systemic treatment for advanced (unresectable)/metastatic pancreatic ductal adenocarcinoma (Stage III/IV), with clear evidence of radiological disease progression
•9. Patients must be enrolled and receive first dose of study treatment within 6 weeks of radiologically confirmed progression
•10. Karnofsky performance status >=70 with no deterioration in the 2 weeks prior to first dose and an estimated life expectancy of greater than 12 weeks

•1. Prior therapy with a compound of the same mechanism of action as RXC004
•2. Patients at higher risk of bone fractures
•3. Any known uncontrolled inter-current illness or persistent clinically significant toxicity related to prior anti-cancer treatment which in the investigator's opinion makes it undesirable for the patient to participate in the study
•4. Patients who have any history of an active other malignancy within 2 years of study entry
•5. Patients with known or suspected brain metastases
•6. Use of anti-neoplastic agents (including immunotherapy and investigational agents) within 3 weeks prior to the first dose of study treatment, or any residual AEs from prior anti-cancer therapies that have not resolved to Grade =1. Use of any investigational drugs within 3 weeks prior to the first dose of study treatment is also prohibited
•7. Patients with a known hypersensitivity to any RXC004 excipients
•8. Patients with a contra-indication for denosumab treatment
•9. Patients who are pregnant or breast-feeding
•10. Known active HIV, hepatitis B (HBV), or hepatitis C (HCV) infections
•11. Use of any live or live-attenuated vaccines against infectious diseases within 4 weeks of initiation of study treatment
•12. Mean resting corrected QTcF >470 ms

发起方

Australian Genomic Cancer Medicine Centre Ltd t/a Omico