RH324 for Advanced Lung Cancer

Overseen By Charles Packard

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: ReHeva Biosciences,Inc.

Must not be taking: Cytochrome P450 inhibitors

Disqualifiers: Cardiac risk, HIV, active infection, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called RH324 for individuals with advanced non-small cell lung cancer. The goal is to determine the optimal dose by administering varying amounts of the drug. It targets those who have not found success with standard treatments such as chemotherapy, targeted therapy, and immunotherapy. Participants must have a measurable lung tumor and be capable of performing daily activities independently. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it mentions a washout period (time without taking certain medications) for prior treatments. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that RH324 is likely to be safe for humans?

Research has shown that RH324 underwent safety testing in people with advanced non-small cell lung cancer. The study explored different doses to assess tolerance. Results indicated that participants managed the treatment without severe side effects at the doses tested. This suggests RH324 is generally safe for humans, but it's important to remember that this is still early research. The safety information is limited to the participants in that study, so consulting a healthcare provider before joining a trial is always advisable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

RH324 is unique because it targets advanced lung cancer in a novel way, potentially offering benefits over traditional treatments like chemotherapy and targeted therapies that often focus on broad cancer cell elimination or specific genetic mutations. RH324's innovative mechanism of action might provide a more precise attack on cancer cells, minimizing damage to healthy cells. Researchers are excited about this treatment because it could lead to fewer side effects and improved effectiveness, offering new hope for patients with advanced lung cancer who have limited options.

What evidence suggests that RH324 might be an effective treatment for advanced lung cancer?

Research shows that RH324 is undergoing testing for advanced non-small cell lung cancer (NSCLC). This treatment targets specific proteins on cancer cells, potentially slowing or stopping cancer growth. Early studies have identified safe dosage levels for RH324, and this trial will explore various doses to find the most effective and safe option. Although detailed efficacy data remains limited, the emphasis on targeted therapy is promising, as similar treatments have proven beneficial in other NSCLC cases. Thus, RH324 could potentially manage the disease by disrupting cancer growth signals. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

Adults over 18 with advanced non-small cell lung cancer who have tried all standard treatments without success. They must not be pregnant, agree to birth control, and abstain from alcohol and supplements. Participants need a life expectancy of more than 2 months, adequate organ function, no serious medical conditions or infections, and the ability to swallow capsules.

Inclusion Criteria

My thyroid function is normal.

You should not consume alcohol or dietary supplements.

Not pregnant, lactating and willing to use birth control throughout study

Exclusion Criteria

I need medication that strongly affects liver enzyme activity.

I have risk factors for heart disease.

I do not have any unstable health conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral RH324 in a dose-ranging study to assess safety and tolerability

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• RH324

Trial Overview

The trial is testing RH324, an oral medication for advanced non-small cell lung cancer. It's a phase 1 study which means it's early in testing and focuses on finding the right dose. Patients will take this drug to see how well it works and what doses are safe.

How Is the Trial Designed?

Group I: Dose Level 3 Experimental Treatment 1 Intervention

RH324

Group II: Dose Level 2 Experimental Treatment 1 Intervention

RH324

Group III: Dose Level 1 Experimental Treatment 1 Intervention

RH324

Who Is Running the Clinical Trial?

ReHeva Biosciences,Inc.

Lead Sponsor

Trials

1

Recruited

6+

Citations

1.

biospace.com

biospace.com/reheva-biosciences-successfully-completes-rh324-phase-i-clinical-trial-for-advanced-non-small-cell-lung-cancer

REHEVA BIOSCIENCES SUCCESSFULLY COMPLETES ...

It evaluated the safety and tolerability of escalating doses of RH324 in patients diagnosed with advanced non-small cell lung cancer (NSCLC) who ...

2.

prnewswire.com

prnewswire.com/news-releases/reheva-biosciences-successfully-completes-rh324-phase-i-clinical-trial-for-advanced-non-small-cell-lung-cancer-301967317.html

REHEVA BIOSCIENCES SUCCESSFULLY COMPLETES ...

It evaluated the safety and tolerability of escalating doses of RH324 in patients diagnosed with advanced non-small cell lung cancer (NSCLC) who ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3228100/

Outcomes of Patients with Advanced Non-Small Cell Lung ...

The outcomes of patients with advanced non-small cell lung cancer (NSCLC) treated in phase I clinical trials have not been systematically analyzed. Methods. We ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11937135/

Update 2025: Management of Non‑Small-Cell Lung Cancer

This review provides a comprehensive update on the evolving management strategies for NSCLC, with a focus on recent developments in screening, diagnostics, and ...

5.

cancerci.biomedcentral.com

cancerci.biomedcentral.com/articles/10.1186/s12935-023-02990-y

Recent advances in non-small cell lung cancer targeted therapy

This updated study aimed to discuss the tumor target antigens comprehensively and targeted therapy-related agents in NSCLC.

6.

withpower.com

withpower.com/trial/phase-1-safety-issues-5-2022-d4623

RH324 for Advanced Lung Cancer · Info for Participants

This Phase 1 medical study run by ReHeva Biosciences,Inc. needs participants to evaluate whether RH324 will have tolerable side effects & efficacy for ...

7.

cancer.gov

cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-09126

Phase 1 Study of Oral RH324 in Advanced Non-Small Cell ...

Phase 1 open label dose ranging study of RH324 in advanced non-small cell lung cancer. Eligibility Criteria, Locations & Contacts, Trial Objectives and Outline.

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05170204

NCT05170204 | A Study Evaluating the Efficacy and Safety ...

This study will evaluate the efficacy and safety of multiple therapies in participants with locally advanced, unresectable, Stage III NSCLC with eligible ...