Actively Recruiting
A Study of RNK08954 in Subjects With Advanced Solid Tumors With KRAS ((Kirsten Rat Sarcoma) G12D Mutation
Led by Ranok Therapeutics (Hangzhou) Co., Ltd. · Updated on 2025-10-30
152
Participants Needed
6
Research Sites
137 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a first in human (FIH), Phase 1/2 open-label multi-center, dose escalation and expansion study to evaluate the safety, tolerability and pharmacokinetics of RNK08954 to determine the optimal dose and recommended dose for expansion and evaluate clinical activity in patients with advanced solid tumors with KRAS G12D mutation. This is a 2-part study: dose exploration/indication expansion and dose optimization ( to identify a dose that preserves clinical benefit with optimal tolerability).
CONDITIONS
Official Title
A Study of RNK08954 in Subjects With Advanced Solid Tumors With KRAS ((Kirsten Rat Sarcoma) G12D Mutation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be 18 years of age or older.
- Must have a locally advanced or metastatic malignancy with KRAS G12D mutations confirmed by DNA sequencing of tumor tissue or circulating DNA.
- Must have received prior standard therapy for their tumor or be unlikely to benefit further from such therapy.
- Must have measurable lesions by CT with contrast or MRI if allergic to contrast.
- Measurable disease may be in previously irradiated areas if at least 3 weeks have passed since radiation.
- Bone disease must have at least 50% lytic component to be measurable.
- Archival or fresh tumor tissue must be available for biomarker evaluation; cytology samples are not sufficient.
- Must have ECOG Performance Status score of 0 or 1.
- Must be able to take oral medications and willing to record daily adherence.
- Must have adequate laboratory values including neutrophil count, hemoglobin, platelet count, liver enzymes, bilirubin, creatinine clearance, coagulation parameters, and serum albumin.
- Must have life expectancy greater than 12 weeks.
- Females of childbearing potential must have a negative pregnancy test before dosing.
- Males and females of childbearing potential must agree to use effective contraception during treatment and for 6 months after.
- Must be able to understand and comply with study procedures and provide informed consent.
- Must be able to eat a standardized high-fat, high-caloric meal within 30 minutes.
- Must be able to fast for at least 10 hours.
- For Phase 1b and Phase 2, must have received 1 to 2 prior lines of systemic chemotherapy for advanced disease.
- KRAS G12D mutation status will be confirmed by a central laboratory.
You will not qualify if you...
- Receiving concurrent anticancer therapies within 28 days or 5 half-lives before study start, except hormonal therapy for breast or prostate cancer.
- Decline in ECOG Performance Status to greater than 1 or weight loss of 10% or more during screening.
- Active or untreated symptomatic central nervous system metastases.
- Unresolved toxicities from prior anticancer treatments above grade 1, except stable and irreversible grade 2 or 3 toxicities.
- Prior radiotherapy to the only measurable disease area unless disease progression documented and patient recovered from acute toxicities.
- Gastrointestinal conditions preventing oral medication intake.
- Significant cardiovascular disease within 6 months prior to enrollment.
- Use of medications causing significant drug interactions with RNK08954 within 2 weeks prior to study.
- Pregnancy, breastfeeding, or planning to breastfeed during study or within 6 months after treatment.
- Untreated HIV infection or insufficient CD4+ cell counts if HIV-positive.
- Active infections requiring systemic treatment.
- Chronic hepatitis B or C infection unless viral loads are undetectable.
- Known allergy to any components of the study drug.
- Other serious uncontrolled medical or psychiatric conditions affecting compliance.
- History of other malignancies except certain treated skin or in-situ cancers without evidence of disease for over 2 years.
- Prior treatment with KRAS G12D or pan KRAS inhibitors.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
Actively Recruiting
2
Henan Cancer Hospital
Zhengzhou, Henan, China
Actively Recruiting
3
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
4
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
5
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
Actively Recruiting
6
Shanghai Chest Hospital
Shanghai, China
Actively Recruiting
Research Team
X
Xin Wu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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