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Not yet recruitingNCT07848893Updated Sep 30, 2026

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

A Phase 2 interventional study of RNK08954 in Advanced Gynecologic Malignancies, sponsored by Ranok Therapuetics Co. Ltd.. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Ranok Therapuetics Co. Ltd. · Phase 2, Interventional, and Treatment

Updated Sep 30, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
120
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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

02

Conditions studied

  • Advanced Gynecologic Malignancies
03

In context

Lead sponsor

This is the only study on the registry with Ranok Therapuetics Co. Ltd. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    RNK08954

    Drug: RNK08954

Interventions

  • DrugRNK08954

    RNK08954 will be administered at the assigned dose level, orally, until disease progression or intolerable toxicity.

06

What researchers measure

Primary outcomes

  1. ORR

    ORR was evaluated by RECIST v1.1.

    Time frame: Up to 2 years

Secondary outcomes

  1. PFS

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

    Time frame: up to 2 years

  2. DOR

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

    Time frame: Up to 2 years

  3. DCR

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

    Time frame: Up to 2 years

  4. OS

    Overall Survival (OS)

    Time frame: Up to 3 years

  5. The incidence and severity of AEs and SAEs

    The incidence and severity of AEs and SAEs

    Time frame: Up to 2 years

  6. CL/F

    apparent clearance

    Time frame: Up to 2 years

  7. Vc/F

    apparent central volume of distribution

    Time frame: up to 2 years

  8. AUC

    area under the concentration-time curve

    Time frame: up to 2 years

07

Study locations

1 site
  • Fudan University Shanghai Cancer Center
    Shanghai, Shanghai Municipality 200032, China
    • Xiaohua Wu, MD · Contact · wu.xh@fudan.edu.cn · 86-13601772486
    • Xiaohua Wu, MD · Principal investigator
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Sep 30, 2026
Show all 1 update
  1. Sep 30, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07848893
Lead sponsor
Ranok Therapuetics Co. Ltd.
Responsible party
Sponsor
First posted
Sep 30, 2026
Start date
Sep 15, 2026 (estimated)
Primary completion
Aug 31, 2028 (estimated)
Completion
Aug 31, 2028 (estimated)
Last update
Sep 30, 2026

Study contacts

Jianghua Chen
Contact
chenjianghua@ranoktherapeutics.com
86-0571-86630936

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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