NCT07303465
Recruiting
Phase 2
A Study to Evaluate the Efficacy and Safety of RNK08954 in Subjects With KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma
Ranok Therapeutics (Hangzhou) Co., Ltd.2 sites in 1 country60 target enrollmentStarted: October 14, 2025Last updated:
InterventionsRNK08954
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Ranok Therapeutics (Hangzhou) Co., Ltd.
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- PFS
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 .
- •Presence of a KRAS G12D mutation.
- •Physical condition score ECOG score 0-1 points.
- •Expected survival ≥ 12 weeks.
- •Have adequate hematologic and end-organ function, with laboratory test results within required parameters within 7 days prior to the first dose.
- •Fertile female subjects and male subjects whose partners are women of reproductive age must agree to comply with the contraceptive requirement from the time of signing the informed consent until 6 months after the final administration of the trial drug.Fertile female subjects must undergo a serum pregnancy test within 7 days before the first dose, and the result is negative; And must be non-lactating.
Exclusion Criteria
- •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
- •Except for certain circumstances, a history of malignant tumors other than the inclusion diagnosis within 2 years prior to the first administration of the drug;
- •History of known severe or uncontrolled cardiovascular or cerebrovascular disease that requires treatment.
- •The patient had previously used KRAS inhibitors or pan-KRAS inhibitors therapy.
- •Received systemic anti-tumor therapy prior to the first dose, or received Chinese herbal preparations with clear anti-pancreatic tumor indications within 2 weeks before the first dose.
- •Having received other investigational drugs or therapies not yet approved for marketing prior to the first dose, with the interval from the last administration or treatment being less than 4 weeks or 5 half-lives (whichever is shorter).
- •Having undergone major surgery or experienced significant trauma within 4 weeks prior to the first dose, or requiring elective surgery during the trial period.
Arms & Interventions
RNK08954
Experimental
Intervention: RNK08954 (Drug)
Outcomes
Primary Outcomes
PFS
Time Frame: up to 2 years
Progression-free survival (PFS) is assessed by investigators using RECIST 1.1 criteria.
Secondary Outcomes
- AUC(Up to 12 months)
- ORR(up to 2 years)
- DOR(up to 2 years)
- DCR(Up to 2 years)
- AEs(Up to 2 years)
Investigators
Study Sites (2)
Loading locations...
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