DOC1021 Immunotherapy for Melanoma

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Diakonos Oncology Corporation

Must be taking: Filgrastim, pIFN

Must not be taking: Immunosuppressants

Disqualifiers: Pregnancy, HIV, Hepatitis, others

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

Compensation: Varies

Number of Visits: 5

35 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new immunotherapy treatment, DOC1021, for individuals with melanoma unresponsive to other treatments. The treatment uses cells from a patient's own blood, combined with parts of their tumor, to help the immune system fight the cancer. Participants will receive a series of injections and attend regular clinic visits to monitor their health. The trial seeks individuals with melanoma that has spread or cannot be surgically removed and who have tried other treatments without success. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have generally shown that DOC1021 is well-tolerated. Research indicates that this treatment has been safely used alongside standard care in other trials, suggesting a positive safety profile. While specific safety data from the current melanoma study is not yet available, DOC1021 has received Fast Track designation from the FDA for other conditions, such as pancreatic cancer and a type of brain tumor called GBM. This designation suggests a favorable safety profile. Before this trial, no major safety issues were reported for DOC1021, indicating it is considered safe enough for continued testing in difficult-to-treat melanoma. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for melanoma?

Unlike the standard treatments for melanoma, such as surgery, chemotherapy, and targeted therapies, DOC1021 offers a novel approach by leveraging the body's immune system. This immunotherapy is administered through injections near the tumor's lymph nodes, which is intended to boost the local immune response directly at the cancer site. Researchers are particularly excited about DOC1021 because it uses a combination of the DOC1021 compound and pIFN to potentially enhance the body's ability to recognize and attack melanoma cells more effectively, offering hope for improved outcomes in melanoma treatment.

What evidence suggests that DOC1021 might be an effective treatment for melanoma?

Research has shown that DOC1021, a treatment utilizing the body's own immune cells, holds promise for treating melanoma, a type of skin cancer. One study found that 88% of patients remained alive 12 months after receiving DOC1021, compared to the typical 60% survival rate with standard treatments. Patients treated with DOC1021 also exhibited more active T-cells, crucial for fighting cancer. This treatment employs the patient's immune cells to combat cancer, potentially improving outcomes for those with hard-to-treat melanoma. These early findings suggest that DOC1021 could effectively help the immune system target cancer cells. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

Inclusion Criteria

I have signed and dated the consent form.

I am 18 years old or older.

I am willing and able to follow all study procedures for its duration.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants receive two doses of DOC1021 under image guidance 2 weeks apart and subcutaneous pIFN injections weekly for a total of 4 doses

4 weeks

4 visits (in-person)

Booster Treatment (Optional)

Participants may receive an optional image-guided perinodal DOC1021 booster injection approximately 6 months after the first DOC1021 dose, along with additional subcutaneous pIFN injections

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including regular clinic visits to assess quality of life, symptoms, medication use, imaging, and bloodwork

5 years

What Are the Treatments Tested in This Trial?

Interventions

• DOC1021

How Is the Trial Designed?

Group I: Experimental: DOC1021 + pIFN Experimental Treatment 3 Interventions

DOC1021 administered by injection near active tumor lesion lymph nodes + pIFN

Who Is Running the Clinical Trial?

Diakonos Oncology Corporation

Lead Sponsor

Trials

1

Recruited

140+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07288112

Study Details | NCT07288112 | DOC1021 Dendritic Cell ...

The goal of this clinical trial is to learn if DOC1021 + pIFN will be safe and will lead to tumor responses in patients with refractory melanoma.

2.

targetedonc.com

targetedonc.com/view/fda-grants-fast-track-designation-to-doc1021-for-cutaneous-melanoma

FDA Grants Fast Track Designation to DOC1021 for ...

FDA Grants Fast Track Designation to DOC1021 for Cutaneous Melanoma ... Recently presented clinical data from the other 2 trials was favorable.

3.

curetoday.com

curetoday.com/view/fda-grants-fast-track-to-doc1021-for-metastatic-and-unresectable-melanoma

FDA Grants Fast Track to DOC1021 for Metastatic and ...

Diakonos Oncology is currently advancing DOC1021 through multiple clinical studies to generate robust data and validate its platform. The ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41838361/

Real-World Outcomes for Patients with Clinically Node- ...

Consistent with clinical trial data, the findings in this study support PR as a strong predictor of survival in this patient population.

5.

dermatologytimes.com

dermatologytimes.com/view/fda-grants-fast-track-designation-to-doc1021-for-unresectable-or-metastatic-cutaneous-melanoma

FDA Grants Fast Track Designation to DOC1021 for ...

Key efficacy outcome: No clinical data reported to date. Key safety ... No clinical data from the refractory melanoma trial have been ...

6.

prnewswire.com

prnewswire.com/news-releases/diakonos-oncology-awarded-fast-track-designation-by-fda-for-doc1021-dubodencel-in-unresectable-or-metastatic-cutaneous-melanoma-302763752.html

Diakonos Oncology Awarded Fast Track Designation by ...

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to DOC1021 for the treatment of pancreatic cancer, GBM, and ...