KRAS G12D MutationsPhase 2NCT07303465
To Evaluate the Safety and Efficacy of RNK08954 in Patients With Metastatic Pancreatic Ductal Adenocarcinoma.
A Phase 2 study testing RNK08954 in people with KRAS G12D Mutations and Pancreatic Ductal Adenocarcinoma (PDAC), run by Ranok Therapeutics (Hangzhou) Co., Ltd. at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- KRAS G12D Mutations, Pancreatic Ductal Adenocarcinoma (PDAC)
- What is being tested?
- RNK08954
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 14 Oct 2025to 30 Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- 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 within 2 weeks prior to the first dose requiring systemic anti-infective therapy.
- 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, subjects can be enrolled if their HBV-DNA is <2000 IU/mL or 10⁴ copies/mL after antiviral therapy).
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Nanjing Tianyinshan Hospital
Nanjing
Shukui Qing, MD, 86-0518-81220689, qinsk81@163.com
- Recruiting
Shanghai GoBroad Cancer Hospital China Pharmaccutical University
Shanghai
Jing Li, MD, 86-021-60571205, jin.li@gobroadhealthcare.com
Jing Li, MD
About this study
Official title: A Study to Evaluate the Efficacy and Safety of RNK08954 in Subjects With KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma
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.
- Being tested
- RNK08954
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RNK08954Drug
RNK08954 will be administered at the assigned dose level, orally, until disease progression or intolerable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| RNK08954 | Experimental | Not described Receives: Drug: RNK08954 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression-free survival (PFS) is assessed by investigators using RECIST 1.1 criteria.
Measured: up to 2 years
Secondary outcomes (5)
ORR
ORR was evaluated by RECIST v1.1.
Measured: up to 2 years
DOR
Duration of response (DoR) is assessed by investigators using RECIST 1.1 criteria.
Measured: up to 2 years
DCR
Disease control rate (DCR) is assessed by investigators using RECIST 1.1 criteria.
Measured: Up to 2 years
AEs
AEs are assessed by NCI-CTCAE v5.0
Measured: Up to 2 years
AUC
Area under the plasma concentration-time curve.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start14 Oct 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KRAS G12D MutationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ranok Therapeutics (Hangzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ShuKui Qing, MD, Principal investigator, Nanjing Tianyinshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07303465
- Sponsor's protocol ID
- RNK08954-05
- Status last verified
- Dec 2025
- First submitted
- 30 Nov 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Efficacy and Safety of RNK08954 in Subjects With KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT07303465
- Acronym / sponsor ID
- RNK08954-05
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ranok Therapeutics (Hangzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RNK08954 | Experimental | Drug: RNK08954 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RNK08954RNK08954 will be administered at the assigned dose level, orally, until disease progression or intolerable toxicity. | Drug | RNK08954 |
Primary outcome
PFS
Time frame: up to 2 years
Progression-free survival (PFS) is assessed by investigators using RECIST 1.1 criteria.
5 secondary outcomes
ORR
Time frame: up to 2 years
DOR
Time frame: up to 2 years
DCR
Time frame: Up to 2 years
AEs
Time frame: Up to 2 years
AUC
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ShuKui Qing, MD principal investigator
Nanjing Tianyinshan Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RNK08954 in people with KRAS G12D Mutations and Pancreatic Ductal Adenocarcinoma (PDAC), run by Ranok Therapeutics (Hangzhou) Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xin Wu (+86 0571 8663 0936, xinwu@ranoktherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.