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Virus Therapy

Intratumoral PH-762 for Skin Cancer

Q: What implications exist with regard to sequential escalating doses of PH-762?

<p>Our appraisal of the safety of Sequential escalating doses of PH-762 on a scale from 1 to 3 is low, as this Phase 1 trial only has scant evidence indicating its efficacy and security.</p>

Q: Are there any opportunities for participation in this trial currently available?

<p>According to clinicaltrials.gov, the recruitment period for this medical study has closed; although it was initially posted on September 1st 2023 and last updated August 25th 2023, no new patients can be admitted. Nevertheless, there are still 3296 other trials actively recruiting participants.</p>

Phase 1

Recruiting

Research Sponsored by Phio Pharmaceuticals Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed cutaneous squamous cell carcinoma (cSCC), melanoma, or Merkel cell carcinoma meeting specific criteria

Presence of a minimum of one accessible tumor of ≥ 1.0 cm and < 3.0 cm in longest dimension for intratumoral injection, biopsy, and surgical excision

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3.5 weeks

Awards & highlights

Study Summary

This trial will study a drug injected into skin cancer tumors to see if it's safe & how the body responds, with surgery two weeks later.

Who is the study for?

This trial is for adults with certain skin cancers: squamous cell carcinoma, melanoma, or Merkel cell carcinoma. They must have at least one tumor between 1 and 3 cm that can be injected and removed surgically. People with other recent cancers, current cancer treatments, serious medical conditions like auto-immune diseases, or who are pregnant/breastfeeding cannot join.Check my eligibility

What is being tested?

The trial tests PH-762's safety by giving participants four weekly injections directly into a single tumor on the skin. After these injections, the treated tumor will be surgically removed to study how it responded to PH-762 and what happens to the drug in the body.See study design

What are the potential side effects?

Potential side effects of PH-762 may include reactions at the injection site such as pain or swelling, general discomfort or flu-like symptoms due to immune response activation. The full range of side effects will be studied during this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with a specific type of skin cancer.

Select...

I have a tumor between 1.0 cm and 3.0 cm that can be reached for treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3.5 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3.5 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3.5 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse Events

Secondary outcome measures

Pathologic response

Pharmacokinetics: area under the curve to last quantifiable plasma concentration (AUClast)

Pharmacokinetics: maximum plasma concentration (Cmax)

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Sequential escalating doses of PH-762.Experimental Treatment1 Intervention

Escalating doses of PH-762 are to be tested, with an observation period between doses.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Phio Pharmaceuticals Inc.Lead Sponsor

1 Previous Clinical Trials

18 Total Patients Enrolled

L MahoneyStudy DirectorPhio Pharmaceuticals Inc.

Linda MahoneyStudy DirectorPhio Pharmaceuticals Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What implications exist with regard to sequential escalating doses of PH-762?

"Our appraisal of the safety of Sequential escalating doses of PH-762 on a scale from 1 to 3 is low, as this Phase 1 trial only has scant evidence indicating its efficacy and security."

Answered by AI

Are there any opportunities for participation in this trial currently available?

"According to clinicaltrials.gov, the recruitment period for this medical study has closed; although it was initially posted on September 1st 2023 and last updated August 25th 2023, no new patients can be admitted. Nevertheless, there are still 3296 other trials actively recruiting participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intratumoral PH-762 for Cutaneous Carcinoma

2023. "Intratumoral PH-762 for Cutaneous Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06014086.

All > Merkel Cell Carcinoma