RNK08954 for KRAS Mutation

(TRIAD1 Trial)

Recruiting at 6 trial locations

Overseen By Xin Wu

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Ranok Therapeutics (Hangzhou) Co., Ltd.

Must not be taking: Herbal medicines, CYP3A4 inhibitors

Disqualifiers: CNS metastases, Cardiovascular disease, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

152 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it does mention that you cannot use certain medications that might interact with the study drug, such as strong inhibitors or inducers of specific enzymes. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

What data supports the effectiveness of the drug RNK08954 for KRAS Mutation?

The research suggests that certain rare KRAS mutations, like A59T, may respond well to targeted therapies, including immunotherapy, due to their association with predictive biomarkers. This implies that RNK08954 might be effective for specific KRAS mutations if it targets similar pathways. ^{1 2 3 4 5}

Research Team

Iman El Hariry, MD

Principal Investigator

Chief Medical Officer

Eligibility Criteria

This trial is for adults with advanced solid tumors that have a specific genetic change called the KRAS G12D mutation. Participants should not have had previous treatments that didn't work or are no longer working, and they must be in good physical condition to handle the study procedures.

Inclusion Criteria

Must have adequate laboratory parameters at baseline.

Must be able to fast for a minimum of 10 hours.

Must be able to understand and comply with the protocol and have provided written informed consent.

Exclusion Criteria

Known hypersensitivity to any components of the study drug.

I have been diagnosed with hepatitis B or C.

Pregnancy, breast-feeding, or planning to breastfeed during the study or within 6 months after treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1a: Dose Escalation

Participants receive oral RNK08954 daily in dose escalation cohorts to determine the optimal dose

12-15 months

Phase 1b: Indication Expansion

Multiple indication cohorts open to evaluate the optimal dose in different cancer types

12-15 months

Phase 2: Dose Optimization

Participants receive two different doses of oral RNK08954 daily to compare and further characterize the optimal dose

12-15 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• RNK08954

Trial Overview The trial is testing RNK08954-01, a new drug for cancer. It's an early-stage study to find out how safe it is, what dose works best, and if it helps against these tumors. Patients will first help find the right dose and then more people will try it at that dose to see how well it works.

Participant Groups

Group I: RNK08954 Experimental Treatment 1 Intervention

Dose-escalation of RNK08954 oral dose therapy once daily.

Who Is Running the Clinical Trial?

Ranok Therapeutics (Hangzhou) Co., Ltd.

Lead Sponsor

Trials

2

Recruited

180+

References

1. China pubmed.ncbi.nlm.nih.gov

Targeted therapies for KRAS-mutant non-small cell lung cancer: from preclinical studies to clinical development-a narrative review. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Therapeutic Outcomes and Clinical Features of Advanced Non-Small Cell Lung Cancer Carrying KRAS Mutations: A Multicenter Real-life Retrospective Study. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Extended RAS analysis for anti-epidermal growth factor therapy in patients with metastatic colorectal cancer. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Expression of Immuno-Oncologic Biomarkers Is Enriched in Colorectal Cancers and Other Solid Tumors Harboring the A59T Variant of KRAS. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Clinical Features and Outcomes of Patients with Colorectal Cancers Harboring NRAS Mutations. [2022]