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Virus Therapy

ANK-101 for Cancer (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

Must not have

Prior organ transplantation

Active autoimmune disease or medical conditions requiring chronic steroid or other immunosuppressive therapy within 28 days prior to the start of treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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

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I am 18 years old or older.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had an organ transplant.

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I haven't taken steroids or immunosuppressants in the last 28 days.

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I am allergic to IL-12, aluminum hydroxide, or polysorbate-20.

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I have previously been treated with IL-12.

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My tumor is pressing on major airways or blood vessels.

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I have a condition that weakens my immune system, like leukemia or lymphoma.

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I am HIV-positive and have had Kaposi sarcoma or Multicentric Castleman Disease.

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I have active cancer spread to my brain or spinal cord.

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I do not have serious heart conditions like heart failure or unstable angina.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine the safety and tolerability of ANK-101 in combination with cemiplimab

Incidence and characteristics of DLTs and TEAEs

RDE of ANK-101

Secondary study objectives

DCR by RECIST v1.1

DOR by RECIST v1.1

Levels of ADA in serum

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: ANK-101 IT Injection in Visceral LesionsExperimental Treatment1 Intervention

IT injections of ANK-101 once every 3 weeks into visceral lesions

Group II: ANK-101 IT Injection in Superficial LesionsExperimental Treatment1 Intervention

IT injections of ANK-101 once every 3 weeks into superficial lesions

Group III: ANK-101 IT Injection in Combination with CemiplimabExperimental Treatment2 Interventions

IT injections of ANK-101 once every 3 weeks in combination with Cemiplimab into patients with high-risk locally advanced or metastatic CSCC that have superficial lesions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cemiplimab

2015

Completed Phase 3

~1470

0 / 12Eligibility criteria met