Orellanine for Renal Cell Carcinoma

Recruiting at 1 trial location

Overseen By Börje Haraldsson, M.D., Ph.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Theradex

Must be taking: Chronic hemodialysis

Must not be taking: Immuno-oncology therapy

Disqualifiers: Other malignancy, Radiotherapy, Pregnant, others

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

Compensation: Varies

Number of Visits: Unknown

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called orellanine for individuals with advanced kidney cancer, specifically clear-cell or papillary renal carcinoma. Researchers aim to determine if orellanine is safe and effective in controlling the cancer. The trial seeks participants who have been on regular hemodialysis for the past three months, have advanced kidney cancer, and lack other treatment options. 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.

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

Research shows that orellanine, a substance found in certain mushrooms, is under investigation for its safety in treating kidney cancers like clear-cell and papillary renal cell carcinoma. Earlier studies demonstrated that orellanine can specifically target kidney cancer cells, potentially reducing side effects on healthy cells.

While orellanine affects cell function, research has primarily focused on its impact on cancer cells rather than healthy ones. The treatment has been tested in both animals and humans, providing some initial safety information. Ongoing research aims to better understand patient tolerance to orellanine and its potential side effects.

As this trial is in the early stages, its main goal is to ensure the treatment's safety for people. Although unknowns remain, the study is designed to carefully monitor for any negative effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for renal cell carcinoma, which often involve surgery, targeted therapies, or immunotherapy, Orellanine offers a unique approach. Orellanine is administered intravenously and is derived from a compound found in certain mushrooms, targeting kidney cancer cells specifically. Researchers are excited because it has a novel mechanism of action, potentially offering new hope for patients who have not responded well to traditional therapies. This specificity could mean fewer side effects and a more efficient attack on cancer cells, making it a promising candidate in the fight against kidney cancer.

What evidence suggests that orellanine might be an effective treatment for renal carcinoma?

Research shows that orellanine, a compound originally found in toxic mushrooms, may help fight kidney cancer. Lab studies have shown that orellanine significantly slows the growth of kidney cancer cells. It reduces these cells' ability to survive, suggesting it might help shrink tumors. These early results are promising, especially for people with advanced clear-cell or papillary kidney cancer, as they suggest a possible new treatment option. Participants in this trial will receive orellanine intravenously to further evaluate its effectiveness and safety. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for adults with advanced clear-cell or papillary renal cell carcinoma (kidney cancer) who can't be helped by standard treatments or choose not to use them. They must have a life expectancy of at least 3 months, stable blood counts, and be on consistent hemodialysis for kidney failure.

Inclusion Criteria

Has acceptable haematologic laboratory values

For females of child-bearing potential, a negative serum pregnancy test at screening

My liver function tests are within normal ranges.

Exclusion Criteria

I haven't had any cancer treatments in the last 2 weeks.

I have not had immunotherapy in the last 6 months.

I haven't had any cancer except for certain skin cancers, superficial melanoma, or early-stage breast, cervical, or prostate cancer in the last 2 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment - Part A: Intra-patient Dose Escalation

Participants undergo intra-patient dose escalation to determine the maximum tolerated dose of orellanine

4-6 weeks

Treatment - Part B: Dose Exposure

Participants receive a consistent dose of orellanine to evaluate safety and tolerability

4-8 weeks

Treatment - Part C: Dose Expansion

Participants receive the determined dose of orellanine to further assess anti-tumor efficacy

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Orellanine

Trial Overview

The study is testing the safety and initial effectiveness of a drug called Orellanine in patients with metastatic kidney cancer. It's an early-stage trial (phase I/II), which means it's partly about finding the right dose and seeing if there are any positive effects.

How Is the Trial Designed?

Group I: Orellanine Experimental Treatment 1 Intervention

Orellanine administered intravenously

Who Is Running the Clinical Trial?

Theradex

Lead Sponsor

Trials

34

Recruited

1,600+

Oncorena AB

Lead Sponsor

Trials

1

Recruited

50+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5710908/

Orellanine specifically targets renal clear cell carcinoma - PMC

Orellanine efficiently reduced the viability of numerous renal cancer cell lines and primary renal cancers obtained from patients undergoing partial or total ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05287945

NCT05287945 | Study of Orellanine in Metastatic Clear- ...

This is an open, non-controlled, phase I/II study evaluating the safety, tolerability, and anti-tumor efficacy of orellanine treatment in patients with ...

3.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2024.42.4_suppl.TPS486

A phase I/II, open label, single arm study on safety ...

The primary objectives of this study are to evaluate the safety and tolerability and to determine the maximum tolerable dose (MTD) of orellanine in patients ...

4.

urologytimes.com

urologytimes.com/view/study-launches-exploring-onc175-in-metastatic-kidney-cancer

Study launches exploring ONC175 in metastatic kidney ...

The phase 1/2 Oncorella-1 trial is expected to enroll up to 40 patients with advanced kidney cancer who are on dialysis due to renal failure.

5.

pubs.acs.org

pubs.acs.org/doi/10.1021/acs.jnatprod.2c01068

Orellanine: From Fungal Origin to a Potential Future Cancer ...

This review will focus on orellanine, a toxic mushroom metabolite that has shown promise as a potential treatment for clear cell renal cell ...

6.

urologytimes.com

urologytimes.com/view/fda-greenlights-trial-of-orellanine-in-metastatic-renal-cell-carcinoma

FDA greenlights trial of orellanine in metastatic renal cell ...

The study will evaluate the investigational drug product ONC175 (orellanine) in patients with metastatic clear cell or papillary renal cell carcinoma (RCC)