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Tests treatment safety and results for KRAS G12D Mutations
Official title To Evaluate the Safety and Efficacy of RNK08954 in Patients With Metastatic Pancreatic Ductal Adenocarcinoma.
ClinicalTrials.gov ID: NCT07303465
What this study is testing
What is RNK08954?
RNK08954 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for kras g12d mutations.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- The people voluntarily joined the study and signed the informed consent, with good compliance and follow-up.
- Male and female people 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 how well it works evaluation criteria (RECIST1.1), imaging diagnosis had at least one...
- Presence of a KRAS G12D mutation.
You likely can't join if
- Diagnosed with other pathological types of pancreatic tumors;
- Presence of uncontrolled symptomatic central nervous system metastases; including leptomeningeal metastasis, spinal cord metastasis, or brainstem...
- Presence of symptomatic, moderate or greater fluid accumulation in serous cavities (e.g., pleural effusion, ascites, pericardial effusion) which...
- Clinical condition with an acute and significant decline, including, but not limited to, a decrease in ECOG performance status to \>1 within 72 hours...
- Except for certain circumstances, a history of malignant tumors other than the inclusion diagnosis within 2 years prior to the first administration...
- History of known severe or uncontrolled cardiovascular or cerebrovascular disease that requires treatment.
See the full eligibility criteria
- The people voluntarily joined the study and signed the informed consent, with good compliance and follow-up.
- Male and female people 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 how well it works 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 people and male people 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...
- 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...
- 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...
- 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...
- Having undergone major surgery or experienced significant trauma within 4 weeks prior to the first dose, or requiring elective surgery during the trial period.
- The presence of severe non-healing wounds, ulcers, fractures, etc., within 4 weeks prior to the first dose.
- Severe infection occurred within 4 weeks prior to the first dose, including but not limited to hospitalization due to infectious complications, bacteremia, or severe pneumonia; presence of systemic active infection...
- Presence of active tuberculosis infection at the time of screening.
- Positive for hepatitis B surface antigen (HBsAg) at screening with hepatitis B virus (HBV) deoxyribonucleic acid (DNA) ≥ 2000 IU/mL or 10⁴ copies/mL (however, people can be enrolled if their HBV-DNA is \<2000 IU/mL or...
- Positive for hepatitis C antibody (HCV-Ab) and positive for hepatitis C virus (HCV) ribonucleic acid (RNA) at screening.
- Known infection with human immunodeficiency virus (HIV) or active Treponema pallidum, except under certain circumstances.
- Presence of any toxicity from previous antitumor therapies that has not recovered to Grade ≤1.
- Other situations that the researchers believe should not be included.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, China
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, China; Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.