Aglatimagene Besadenovec + Valacyclovir for Prostate Cancer

Recruiting at 1 trial location

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Candel Therapeutics, Inc.

Must not be taking: Corticosteroids, Immunosuppressants

Disqualifiers: Active liver disease, HIV, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately 6-8 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for men with localized, favorable intermediate-risk prostate cancer who plan to receive external beam radiation therapy (EBRT). The study tests a combination of a gene therapy drug, aglatimagene besadenovec, with the antiviral medication valacyclovir to evaluate how the treatment spreads in the body and affects cancer markers. Men diagnosed with prostate cancer and able to undergo radiation therapy might be suitable candidates for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in prostate cancer therapy.

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

Research has shown that combining aglatimagene besadenovec with valacyclovir delivered promising results in earlier studies. Participants who received this treatment remained cancer-free longer, indicating its effectiveness and general tolerability.

Regarding safety, these studies have not identified any major side effects, which is encouraging for those considering joining the trial. This treatment has been tested in patients with prostate cancer and showed positive results without significant adverse effects. This safety record offers reassurance for potential participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for prostate cancer, which often include hormone therapy, radiation, or surgery, aglatimagene besadenovec is a gene therapy that uses a modified virus to target and destroy cancer cells. Researchers are excited about this treatment because it introduces a novel mechanism of action by directly attacking the cancer cells' genetic material, potentially leading to more precise and effective treatment. Additionally, when used in combination with valacyclovir, an antiviral medication, this approach may enhance the therapy's effectiveness, offering hope for improved outcomes.

What evidence suggests that aglatimagene besadenovec plus valacyclovir might be an effective treatment for prostate cancer?

Research shows that aglatimagene besadenovec, also called CAN-2409, may help treat prostate cancer. Studies found that patients who received this treatment had a 38% improvement in remaining cancer-free for a longer time. In this trial, participants will receive aglatimagene besadenovec alongside valacyclovir and radiation therapy. Previous studies suggest that this combination greatly reduced the chances of cancer recurrence or death. This indicates the treatment could effectively manage prostate cancer, especially in men with intermediate risk. The evidence supports its potential to improve outcomes for men planning to receive external beam radiation therapy (EBRT). ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

Men with localized, favorable intermediate-risk prostate cancer who are over 18 and fit enough for radiation therapy can join. They must have normal organ function tests, no severe illnesses that could affect the trial, no prior prostate cancer treatments (except TURP), and not be on high-dose steroids or immunosuppressants.

Inclusion Criteria

Participants must give study-specific informed consent prior to enrollment

Participants meeting National Comprehensive Cancer Network (NCCN) favorable, intermediate-risk criteria

My prostate cancer is confirmed by tissue analysis.

Exclusion Criteria

I do not have any serious illnesses that would stop me from receiving treatment.

I have had prostate cancer treatment, but TURP is the only procedure I've undergone.

Known sensitivity or allergic reactions to acyclovir or valacyclovir

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 3 courses of injections of aglatimagene besadenovec followed by valacyclovir, with EBRT starting after the second injection

Approximately 6-8 weeks

Multiple visits for injections and EBRT

Follow-up

Participants are monitored for safety and effectiveness, including biomarker and biodistribution assessments

Up to 3 months post last injection

What Are the Treatments Tested in This Trial?

Interventions

• Aglatimagene Besadenovec

Trial Overview

The study is testing aglatimagene besadenovec plus valacyclovir in men planning to receive external beam radiation therapy. It's a Phase 2a trial to see how these drugs affect certain biomarkers and their distribution within the body.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Patients receiving the experimental drug

Who Is Running the Clinical Trial?

Candel Therapeutics, Inc.

Lead Sponsor

Trials

12

Recruited

1,300+

Citations

1.

ir.candeltx.com

ir.candeltx.com/news-releases/news-release-details/candel-therapeutics-presents-positive-phase-3-can-2409-results

Candel Therapeutics Presents Positive Phase 3 CAN-2409 ...

The Company's phase 3 clinical trial met its primary endpoint and secondary endpoints and demonstrated statistically significant improvement in DFS.

2.

ir.candeltx.com

ir.candeltx.com/news-releases/news-release-details/candel-therapeutics-presents-phase-3-clinical-trial-can-2409

Candel Therapeutics Presents Phase 3 Clinical Trial of ...

The trial achieved its primary endpoint with a 30% improvement in disease-free survival (HR 0.7, p=0.0155) and demonstrated a 38% improvement in ...

3.

renalandurologynews.com

renalandurologynews.com/news/urology/prostate-cancer/prostate-cancer-can-2409-immunotherapy-efficacy-treatment-risk/

CAN-2409 Immunotherapy Shows Efficacy for Intermediate ...

Patients who received CAN-2409 had a significant 38% prolonged prostate cancer-specific DFS (HR, 0.62; 95% CI, 0.44-0.87; P =.0046). A higher ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02768363

NCT02768363 | Randomized Controlled Trial of CAN-2409 ...

The purpose of this study is to evaluate the effectiveness of CAN-2409 immunotherapy in patients undergoing active surveillance for localized prostate cancer.

5.

onclive.com

onclive.com/view/can-2409-improves-dfs-in-intermediate-high-risk-localized-prostate-cancer

CAN-2409 Improves DFS in Intermediate/High-Risk ...

CAN-2409 combined with valacyclovir and radiation therapy significantly improved DFS in prostate cancer patients, reducing recurrence or death ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07332000

A Biomarker Study in Men With Localized Prostate Cancer ...

Approximately 30 patients with favorable risk prostate cancer and will receive 3 courses of injections of aglatimigene besadenovec followed by ...

7.

clin.larvol.com

clin.larvol.com/trial-detail/NCT01436968

Phase 3 Study of ProstAtak® Immunotherapy With ...

"CAN-2409 significantly improved prostate cancer-specific outcomes (HR 0.62; p=0.0046).