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Virus Therapy

ANK-101 IT Injection for Soft Tissue Disease (ANCHOR Trial)

Phase 1

Recruiting

Research Sponsored by Ankyra Therapeutics, Inc

Eligibility Criteria Checklist

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

Must have

Histologically or cytologically confirmed diagnosis of cutaneous, subcutaneous, soft tissue, or nodal advanced solid tumor malignancy; metastatic disease eligible

≥ 18 years of age on day of signing informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

ANCHOR Trial Summary

This trial tests a new drug to see if it's safe and effective for treating advanced solid tumors.

Who is the study for?

This trial is for individuals with advanced solid tumors, including skin cancer and metastatic tumors. Participants must be able to receive injections directly into their tumor.Check my eligibility

What is being tested?

The study is testing ANK-101, a new treatment given as an injection directly into the tumor (intratumoral). It's in Phase 1 to see how safe it is and what dose might be best.See study design

What are the potential side effects?

Since this is a Phase I trial primarily focused on safety, specific side effects of ANK-101 are not yet fully known but may include pain at the injection site, swelling, and potential immune reactions.

ANCHOR Trial Eligibility Criteria

Inclusion Criteria

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

Select...

My cancer originates from skin, under the skin, soft tissue, or lymph nodes and has spread.

Select...

I am 18 years old or older.

Select...

I am fully active and can carry on all my pre-disease activities without restriction.

ANCHOR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Incidence and characteristics of DLTs and TEAEs

RDE of ANK-101

Secondary outcome measures

DCR by RECIST v1.1

DOR by RECIST v1.1

Levels of ADA in serum

+7 more

ANCHOR Trial Design

1Treatment groups

Experimental Treatment

Group I: ANK-101 IT InjectionExperimental Treatment1 Intervention

IT injections of ANK-101 once every 3 weeks

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ankyra Therapeutics, IncLead Sponsor

Joseph Elassal, MD, MBAStudy DirectorAnkyra Therapeutics, Inc

Frequently Asked Questions

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

Has the FDA sanctioned ANK-101 IT Injection?

"Due to the limited data on both safety and efficacy, ANK-101 IT Injection received a score of 1."

Answered by AI

Are there any opportunities for interested individuals to participate in this trial?

"The clinical trial page on clinicialtrials.gov reveals that this particular study is not currently recruiting participants, having been initially posted on December 1st 2023 and last edited 6 days later. Although this medical research is closed to new patients, 3015 alternative studies are actively seeking volunteers at the moment."

Answered by AI

What is the endgame of this experiment?

"Over the course of a year, this clinical trial will evaluate incidences and characteristics of DLTs (drug-induced adverse events) and TEAEs (treatment emergent adverse effects). Moreover, information related to pharmacokinetics and efficacy such as apparent volume distribution at steady state, best overall response according to RECIST v1.1 criteria, and progression free survival based on RECIST v1.1 will be collected for secondary outcomes."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase I Study of ANK-101 in Advanced Tumors

2024. "Phase I Study of ANK-101 in Advanced Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06171750.

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