Actively Recruiting
To Evaluate the Safety and Efficacy of RNK08954 in Patients With Metastatic Pancreatic Ductal Adenocarcinoma.
Led by Ranok Therapeutics (Hangzhou) Co., Ltd. · Updated on 2025-12-24
60
Participants Needed
2
Research Sites
58 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
To Evaluate the Safety and Efficacy of RNK08954 in Patients With Metastatic Pancreatic Ductal Adenocarcinoma.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and provide informed consent with good compliance and follow-up
- Male or female aged 18 to 75 years
- Confirmed diagnosis of pancreatic ductal adenocarcinoma by pathology or cytology
- At least one measurable lesion by imaging per RECIST1.1 criteria
- Presence of KRAS G12D mutation
- ECOG performance status of 0 or 1
- Expected survival of at least 12 weeks
- Adequate blood and organ function with lab tests within required parameters within 7 days before first dose
- Fertile participants agree to contraceptive use from consent signing until 6 months after last dose
- Fertile female participants must have a negative serum pregnancy test within 7 days before first dose and must not be breastfeeding
You will not qualify if you...
- Other pathological types of pancreatic tumors
- Uncontrolled symptomatic central nervous system metastases including leptomeningeal, spinal cord, or brainstem metastases
- Symptomatic moderate or greater fluid accumulation in serous cavities requiring intervention or judged ineligible
- Acute significant decline in clinical condition, such as ECOG >1 within 72 hours before baseline, weight loss ≥10% during screening, or BMI <18.0 kg/m²
- History of other malignant tumors within 2 years before first drug administration except certain circumstances
- Severe or uncontrolled cardiovascular or cerebrovascular disease requiring treatment
- Prior use of KRAS inhibitors or pan-KRAS inhibitors
- Systemic anti-tumor therapy or Chinese herbal therapy with anti-pancreatic tumor effect within 2 weeks before first dose
- Use of other investigational drugs or therapies within 4 weeks or 5 half-lives before first dose
- Major surgery, significant trauma within 4 weeks before first dose, or planned elective surgery during study
- Severe non-healing wounds, ulcers, fractures within 4 weeks before first dose
- Severe infection requiring hospitalization or systemic anti-infective therapy within 4 weeks before first dose
- Active tuberculosis infection at screening
- Positive hepatitis B surface antigen with high viral load unless controlled by antiviral therapy
- Positive hepatitis C antibody and RNA at screening
- Known HIV infection or active syphilis except under certain conditions
- Unresolved toxicity from prior antitumor therapies greater than Grade 1
- Other conditions deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Nanjing Tianyinshan Hospital
Nanjing, China
Actively Recruiting
2
Shanghai GoBroad Cancer Hospital China Pharmaccutical University
Shanghai, China
Actively Recruiting
Research Team
X
Xin Wu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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