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

NCT07848893 | Not Yet Recruiting Phase 2

• 1 other identifier: RNK08954-202
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Advanced Gynecologic Malignancies

Outcome Measures

Primary Outcomes (1)

• ORR

  ORR was evaluated by RECIST v1.1.

  Up to 2 years

Secondary Outcomes (8)

• PFS

  up to 2 years

• DOR

  Up to 2 years

• DCR

  Up to 2 years

• OS

  Up to 3 years

• The incidence and severity of AEs and SAEs

  Up to 2 years

Study Arms (1)

RNK08954

EXPERIMENTAL

Drug: RNK08954

Interventions

RNK08954 DRUG

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

RNK08954

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Ranok Therapuetics Co. Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Central Study Contacts

Jianghua Chen

CONTACT

86-0571-86630936; chenjianghua@ranoktherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 30, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: September 30, 2026

Record last verified: 2026-09

Locations

CN (1)