Rhenium Re 188 P2045 for Lung Cancer

Not currently recruiting at 1 trial location

Overseen By For trial location information Andarix

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Andarix Pharmaceuticals

Disqualifiers: Diabetes, Hypertension, Bipolar, 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 aims to determine the highest safe dose of the new drug Rhenium Re 188 P2045 for lung cancer treatment. The researchers will gradually increase the drug dose to ensure it does not cause harmful side effects. Suitable candidates have lung cancer that has progressed after chemotherapy or have opted out of standard chemotherapy. They must have a tumor measurable by a CT scan that has not recently received radiation unless it has grown significantly. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that Rhenium Re 188 P2045 is likely to be safe for humans?

Research has shown that Rhenium Re 188 P2045 was well tolerated in earlier studies. In one study, patients managed the treatment without major problems. Researchers identified which patients might benefit most from this treatment by carefully monitoring for side effects and adjusting doses to ensure safety. While this study aims to find the safest dose, previous testing indicates that the treatment appears safe for use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Rhenium Re 188 P2045 is unique because it uses a radioactive isotope, Rhenium-188, to target lung cancer cells directly. Unlike traditional chemotherapy, which affects both healthy and cancerous cells, this treatment aims to deliver radiation precisely to the tumor, minimizing damage to surrounding tissues. Researchers are excited about this approach because it could potentially lead to fewer side effects and more effective tumor shrinkage, offering a targeted treatment option that current therapies like chemotherapy and radiation often struggle to achieve.

What evidence suggests that Rhenium Re 188 P2045 might be an effective treatment for lung cancer?

Research has shown that Rhenium Re 188 P2045, the treatment under study in this trial, may help treat lung cancer. This treatment is a targeted radiopeptide, using a radioactive element combined with a molecule that locates specific cancer cells. Studies have found that it targets cells with a protein called SSTR2, often present in lung cancers. Early results suggest it is well-tolerated by patients, meaning it doesn't cause severe side effects at lower doses. Imaging studies have also demonstrated its ability to effectively locate cancer cells, aiding doctors in focusing the treatment. While more research is needed, these early findings are promising for its potential effectiveness. ^{1 2 4 5 6}

Who Is on the Research Team?

Andarix Study Director

Principal Investigator

Andarix Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for adults with advanced or recurrent lung cancer (NSCLC or SCLC) who have seen their disease progress after chemotherapy, or those who refused standard chemo. They must have a measurable tumor that hasn't been treated with radiation, or one that has grown significantly if previously irradiated.

Inclusion Criteria

My lung cancer is advanced, recurrent, or has spread.

My cancer has worsened after chemotherapy or I chose not to undergo standard chemotherapy.

My tumor is at least 1 cm big in a non-radiated area or has grown 50% in a radiated area.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive escalating doses of Rhenium Re 188 P2045 to determine the maximum tolerated dose

4 weeks

Multiple visits for dose administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Regular visits for safety assessments and tumor progression analysis

What Are the Treatments Tested in This Trial?

Interventions

• Rhenium Re 188 P2045

Trial Overview The study is testing the safety of different doses of an experimental drug called Rhenium Re 188 P2045 in lung cancer patients. The goal is to find the highest dose patients can take without serious side effects by starting low and gradually increasing.

How Is the Trial Designed?

Group I: Arm 1 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Andarix Pharmaceuticals

Lead Sponsor

Trials

1

Recruited

60+

Published Research Related to This Trial

Current standard treatment for advanced non-small-cell lung cancer involves doublet chemotherapy, which has shown 1-year survival rates of approximately 35% and 2-year survival rates of about 15%.

Preliminary studies indicate that triplet therapy may enhance survival rates compared to double therapy, with toxicity rates being low enough to support the development of these three-drug combinations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Triplet combination chemotherapy and targeted therapy regimens. Bunn, PA.[2005]

Cisplatin-based chemotherapy is preferred for treating advanced nonsmall cell lung cancer, with carboplatin as an alternative for patients with contraindications; nonplatinum regimens are also available for those who cannot tolerate platinum-based treatments.

There is no evidence that higher doses of cisplatin improve survival compared to standard doses, and a minimum of four to six cycles of chemotherapy is recommended for patients who respond well.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First- and second-line therapy for advanced nonsmall cell lung cancer. Sculier, JP., Moro-Sibilot, D.[2018]

In a phase II study involving 39 patients with completely resected stage II or III non-small cell lung cancer, 92.3% completed four cycles of adjuvant chemotherapy with nedaplatin and irinotecan, indicating high tolerability of this regimen.

The treatment resulted in a median disease-free survival of 49.4 months and a 5-year overall survival rate of 69.8%, suggesting that nedaplatin and irinotecan are effective options for improving outcomes in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II study of nedaplatin and irinotecan as adjuvant chemotherapy for completely resected non-small cell lung cancer. Murakami, S., Saito, H., Kondo, T., et al.[2019]

Irinotecan, a topoisomerase I inhibitor, showed a promising 32% response rate in a phase II study for non-small-cell lung cancer, and when combined with cisplatin, the response rate increased to 54% in a phase I trial.

In stage IV non-small-cell lung cancer patients, the combination of irinotecan and cisplatin provided a significant survival advantage, with a median survival time of 50 weeks compared to 36.4 weeks for vindesine/cisplatin, indicating potential benefits of this combination therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Establishment of the standard regimen for non-small-cell lung cancer in Japan. Masuda, N.[2018]

Cisplatin-based chemotherapy has shown a modest survival benefit in patients with locally advanced, inoperable non-small cell lung cancer when combined with radiation therapy, potentially doubling or tripling long-term survival rates despite only a modest improvement in median survival.

While there is some evidence supporting the use of cisplatin-based chemotherapy as an adjuvant treatment after surgery for operable lung cancer, results are mixed, and further studies are needed to clarify its effectiveness compared to other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The treatment of non-small cell lung cancer: current perspectives and controversies, future directions. Bunn, PA.[2007]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT00100256

Study Details | NCT00100256 | Rhenium Re 188 P2045 in ... The purpose of this study is to determine the maximum dose that is safely tolerated of the experimental drug Rhenium Re 188 P2045.

2. jto.org jto.org/article/S1556-0864(15)31282-X/fulltext

Phase I Trial of Rhenium Re188 P2045, a Somatostatin ... Patients were required to have stage IIIb or IV or recurrent non-small cell lung cancer or extensive stage or recurrent small cell lung cancer, performance ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2017.35.15_suppl.e20016

Targeted radiopeptide therapy Re188-P2045 to treat ... This study was conducted to determine the ability of Rhenium Re 188 P2045, a radiolabeled somatostatin analog specific for SSTR2 to both image ( ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/19884860/

phase I trial of rhenium Re188 P2045, a somatostatin analog This trial demonstrated that Re-188 P2045 was well tolerated. Tc-99m P2045 imaging allows identification of patients who may benefit from this treatment.

5. sciencedirect.com sciencedirect.com/science/article/pii/S155608641531282X

Phase I Trial of Rhenium Re188 P2045, a Somatostatin ... Patients were required to have stage IIIb or IV or recurrent non-small cell lung cancer or extensive stage or recurrent small cell lung cancer, performance ...

6. clinicaltrials.bayer.com clinicaltrials.bayer.com/study/91168

Lung Neoplasms || Carcinoma, Non-Small-Cell ... The purpose of this study is to determine the maximum dose that is safely tolerated of the experimental drug Rhenium Re 188 P2045. This will be done by first ...