This is a multicenter, open-label, phase Ⅱa study to explore the safety, tolerability, and preliminary efficacy of RNK08954 in metastatic pancreatic ductal adenocarcinoma harboring a KRAS G12D mutation.
The subjects voluntarily joined the study and signed the informed consent, with good compliance and follow-up.
Male and female subjects aged 18-75 years (including 18 and 75 years).
Pancreatic ductal adenocarcinoma confirmed by pathology (histology) or cytology.
At the time of study enrollment, according to the solid tumor efficacy evaluation criteria (RECIST1.1), imaging diagnosis had at least one measurable lesion .
Diagnosed with other pathological types of pancreatic tumors;
Presence of uncontrolled symptomatic central nervous system metastases; including leptomeningeal metastasis, spinal cord metastasis, or brainstem metastasis.
Presence of symptomatic, moderate or greater fluid accumulation in serous cavities (e.g., pleural effusion, ascites, pericardial effusion) which either necessitates therapeutic intervention or is judged by the investigator to make the patient ineligible.
Clinical condition with an acute and significant decline, including, but not limited to, a decrease in ECOG performance status to >1 within 72 hours prior to the baseline visit and initiation of study treatment, a weight loss of ≥10% during the screening period, or a BMI <18.0 kg/m²
Single group
RNK08954
DrugRNK08954 will be administered at the assigned dose level, orally, until disease progression or intolerable toxicity.
PFS
Progression-free survival (PFS) is assessed by investigators using RECIST 1.1 criteria.
ORR
ORR was evaluated by RECIST v1.1.
DOR
Duration of response (DoR) is assessed by investigators using RECIST 1.1 criteria.
DCR
Disease control rate (DCR) is assessed by investigators using RECIST 1.1 criteria.
AEs
AEs are assessed by NCI-CTCAE v5.0
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