AzTrials
AzTrials

Advanced Gynecologic MalignanciesPhase 2NCT07848893

To Evaluate the Safety and Efficacy of RNK08954 in Patients With Advanced Gynecological Tumors.

A Phase 2 study testing RNK08954 in people with Advanced Gynecologic Malignancies, run by Ranok Therapuetics Co. Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This is a multicenter, open-label, phase II clinical study to evaluate the safety and preliminary efficacy of RNK08954 in patients with advanced gynecological tumors Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Advanced Gynecologic Malignancies
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
120 participants
Where
1 siteChina
Study dates
15 Sep 2026to 31 Aug 2028
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
  • Age ≥ 18 years, female.
  • Physical condition score ECOG score 0-1 points.
  • Expected survival ≥ 12 weeks.
  • At the time of study enrollment, according to the solid tumor efficacy evaluation criteria (RECIST1.1), imaging diagnosis had at least one measurable lesion.
  • Have adequate hematologic and end-organ function, with laboratory test results within required parameters within 7 days prior to the first dose.
Show all 9Show fewer
  • Histologically or cytologically confirmed advanced gynecological malignancy (including ovarian cancer, endometrial cancer, cervical cancer, etc.) with disease progression after at least one prior systemic therapy.
  • Presence of a KRAS G12D mutation.
  • Participants and their partners agree to comply with the contraceptive requirement from the time of screening until 6 months after the final administration of the trial drug and agree to use effective non-pharmacological contraceptive measures during the trial period.

Who cannot join

  • Presence of uncontrolled symptomatic central nervous system metastases; including leptomeningeal metastasis, spinal cord metastasis, or brainstem metastasis.
  • Presence of symptomatic and uncontrolled body cavity effusions.
  • 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.
  • Having received other investigational drugs or systemic anti-tumor 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.
Show all 23Show fewer
  • 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. 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.
  • Currently taking any medication that may have clinically relevant drug-drug interactions with RNK08954.
  • Presence of any toxicity from previous antitumor therapies that has not recovered to Grade ≤1.
  • Unable to take oral medications, or presence of gastrointestinal conditions that, in the investigator's judgment, significantly affect drug absorption, such as dysphagia, treatment-refractory nausea and vomiting, or malabsorption syndrome.
  • Prior total gastrectomy or total small bowel resection, symptomatic inflammatory bowel disease, partial or complete intestinal obstruction, or any other severe acute or chronic gastrointestinal disease that may increase the risk of study participation, including abdominal fistula, gastrointestinal perforation, or history of peptic ulcer disease.
  • Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
  • History of interstitial lung disease (ILD)/non-infectious pneumonitis requiring corticosteroid therapy within 6 months prior to the first dose, or currently has ILD/non-infectious pneumonitis, or suspected ILD/non-infectious pneumonitis (e.g., idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonia, etc.), or other moderate to severe acute or chronic pulmonary disease history.
  • History of psychotropic substance abuse or drug addiction.
  • Severe psychological or psychiatric disorders that may affect the participant's compliance with study procedures.
  • Active autoimmune disease that required systemic treatment within the past 2 years, or autoimmune disease that, in the investigator's judgment, is at risk of recurrence or planned for treatment.
  • Known hypersensitivity or intolerance to RNK08954 or any of its excipients; or history of severe allergic disposition.
  • Other situations that the researchers believe should not be included.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jianghua Chen contact

86-0571-86630936

chenjianghua@ranoktherapeutics.com

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Xiaohua Wu, MD, 86-13601772486, wu.xh@fudan.edu.cn

    Xiaohua Wu, MD

Other trials in China

About this study

Official title: A Phase II Clinical Study to Evaluate RNK08954 in Participants With Advanced Gynecologic Malignancies Harboring the KRAS G12D Mutation

This is a multicenter, open-label, phase II clinical study to evaluate the safety and preliminary efficacy of RNK08954 in patients with advanced gynecological tumors

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 groups in NCT07848893
Study groupRoleWhat they receive
RNK08954ExperimentalNot described
Receives: Drug: RNK08954

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR

    ORR was evaluated by RECIST v1.1.

    Measured: Up to 2 years

Secondary outcomes (8)

  1. PFS

    Progression-free survival (PFS) is assessed by investigators using RECIST 1.1 criteria.

    Measured: up to 2 years

  2. DOR

    Duration of response (DoR) is assessed by investigators using RECIST 1.1 criteria.

    Measured: Up to 2 years

  3. DCR

    Disease control rate (DCR) is assessed by investigators using RECIST 1.1 criteria.

    Measured: Up to 2 years

  4. OS

    Overall Survival (OS)

    Measured: Up to 3 years

  5. The incidence and severity of AEs and SAEs

    The incidence and severity of AEs and SAEs

    Measured: Up to 2 years

  6. CL/F

    apparent clearance

    Measured: Up to 2 years

  7. Vc/F

    apparent central volume of distribution

    Measured: up to 2 years

  8. AUC

    area under the concentration-time curve

    Measured: up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2026
  2. Study start15 Sep 2026 (estimated)
  3. Primary completion31 Aug 2028 (estimated)
  4. Study completion31 Aug 2028 (estimated)

Resources

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
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07848893
Sponsor's protocol ID
RNK08954-202
Status last verified
Sep 2026
First submitted
31 Aug 2026
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RNK08954 in people with Advanced Gynecologic Malignancies, run by Ranok Therapuetics Co. Ltd. at 1 site 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 23 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: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 Jianghua Chen (86-0571-86630936, chenjianghua@ranoktherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (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?

On the ClinicalTrials.gov record for NCT07848893.

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 30 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in