Actively Recruiting
A Phase 1/2 Open-label Study of RNK08954 in Patients With Advanced Solid Tumors With KRAS G12D Mutation
Led by Ranok Therapeutics (Hangzhou) Co., Ltd. · Updated on 2025-10-30
152
Participants Needed
6
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating RNK08954, an oral drug, in patients with advanced solid tumors that have a specific KRAS G12D mutation. This first-in-human Phase 1/2 study aims to assess the safety, tolerability, and how the drug moves through the body, while determining the best dose for further study. The trial includes dose exploration, expansion to different cancer types, and dose optimization phases to balance benefit and side effects. In the initial phase (Phase 1a), patients receive daily oral doses of RNK08954 with careful monitoring of different dose levels. After identifying the optimal dose, Phase 1b opens with groups of patients having colorectal cancer, pancreatic adenocarcinoma, or other cancers to receive the drug daily. Later, Phase 2 compares two different daily doses to refine the treatment plan. Each treatment cycle lasts three weeks. Participants will undergo scans like CT or MRI to measure tumor response and provide tumor tissue samples for biomarker analysis. Researchers will monitor side effects, lab tests, and drug levels in the blood to understand safety and effectiveness. The main outcomes include treatment-emergent adverse events and identifying the best biological dose. The study is expected to last 12 to 15 months, with ongoing assessments of overall survival and response rates.
CONDITIONS
Brief 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.
- Have locally advanced or metastatic cancer with KRAS G12D mutation confirmed by DNA sequencing.
- Have received prior standard therapy or be unlikely to benefit from standard care.
- Have measurable lesions on CT or MRI scans according to RECIST 1.1 criteria.
- Have available tumor tissue samples for biomarker testing.
- Have ECOG performance status of 0 or 1.
- Be able to take oral medications daily and agree to record adherence.
- Have adequate laboratory values including blood counts, liver and kidney function.
- Have life expectancy greater than 12 weeks.
- Females of childbearing potential must have negative pregnancy tests.
- Agree to use effective contraception during and 6 months after treatment.
- Be able to understand and provide informed consent.
- Be able to eat a standardized high-fat meal and fast as required for food effect assessment.
- For Phase 1b and 2, have had 1 to 2 prior lines of systemic chemotherapy.
- KRAS G12D mutation status will be confirmed by central lab.
You will not qualify if you...
- Receiving other anticancer treatments within 28 days or 5 half-lives before study start.
- Decline in performance status to greater than 1 or significant weight loss during screening.
- Active or symptomatic untreated brain metastases.
- Unresolved toxicities from prior cancer treatments above specified grade.
- Prior radiotherapy to only measurable disease area without progression.
- Conditions preventing oral medication intake such as severe GI diseases.
- Significant cardiovascular disease within 6 months before enrollment.
- Use of medications causing drug interactions with RNK08954.
- Pregnancy, breastfeeding, or planning to breastfeed during study and 6 months after.
- Untreated HIV infection or active infections requiring systemic treatment.
- Known active hepatitis B or C infection unless viral loads undetectable.
- Known allergy to study drug components.
- Other serious uncontrolled medical or psychiatric conditions.
- History of other cancers within 2 years except certain treated skin or in-situ cancers.
- Prior treatment with KRAS G12D or pan-KRAS inhibitors.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 to 15 months
Participants will receive daily oral RNK08954 in 3-week cycles as part of dose-escalation and dose optimization phases.
Daily oral medication with multiple visits according to dose escalation and study phase
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
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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