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Virus Therapy

AO-176 for Solid Tumors

Phase 1 & 2

Waitlist Available

Research Sponsored by Arch Oncology

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

Study Summary

This trial is testing a new drug, AO-176, to see if it is safe and effective in treating patients with advanced solid tumors.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Safety of AO-176 and paclitaxel assessed by adverse events and laboratory abnormalities

Safety of AO-176 and pembrolizumab assessed by adverse events and laboratory abnormalities

Safety of AO-176 assessed by adverse events and laboratory abnormalities

Secondary outcome measures

AO-176 + paclitaxel anti-tumor activity assessed by changes in response criteria

AO-176 + pembrolizumab anti-tumor activity assessed by changes in response criteria

AO-176 anti-tumor activity assessed by changes in response criteria

Trial Design

6Treatment groups

Experimental Treatment

Group I: AO-176 Dose ExpansionExperimental Treatment1 Intervention

Once the MTD/RP2D has been established, tumor-specific dose expansion cohorts will be recruited to further assess safety and evaluate preliminary efficacy of AO-176.

Group II: AO-176 Dose EscalationExperimental Treatment1 Intervention

Each dose escalation cohort will initially recruit 3 patients to receive AO-176 in a standard 3+3 design; cohorts will be expanded in the event of a DLT.

Group III: AO-176 + Pembrolizumab Dose ExpansionExperimental Treatment1 Intervention

Once the MTD/RP2D has been established, tumor-speciﬁc dose expansion cohorts will be recruited to further assess safety and evaluate preliminary efﬁcacy of AO-176 + pembrolizumab.

Group IV: AO-176 + Pembrolizumab Dose EscalationExperimental Treatment1 Intervention

Each dose escalation cohort will initially recruit 3 patients to receive AO-176 and pembrolizumab in a standard 3+3 design; cohorts will be expanded in the event of a DLT.

Group V: AO-176 + Paclitaxel Dose ExpansionExperimental Treatment1 Intervention

Once the MTD/RP2D has been established, tumor-speciﬁc dose expansion cohorts will be recruited to further assess safety and evaluate preliminary efﬁcacy of AO-176 + paclitaxel.

Group VI: AO-176 + Paclitaxel Dose EscalationExperimental Treatment1 Intervention

Each dose escalation cohort will initially recruit 3 patients to receive AO-176 and paclitaxel in a standard 3+3 design; cohorts will be expanded in the event of a DLT.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AO-176

2019

Completed Phase 2

~70

AO-176 + Pembrolizumab

2019

Completed Phase 2

~60

AO-176 + Paclitaxel

2019

Completed Phase 2

~60

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Arch OncologyLead Sponsor

1 Previous Clinical Trials

10 Total Patients Enrolled

Merck Sharp & Dohme LLCIndustry Sponsor

3,887 Previous Clinical Trials

5,054,557 Total Patients Enrolled

Benajmin Oshrine, MDStudy DirectorArch Oncology

Frequently Asked Questions

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

Has AO-176 been the subject of any other investigations?

"The first trial of AO-176 was conducted at City of Hope Comprehensive Cancer Center in 1997, with 1370 studies having been completed since then. At present, 1697 clinical trials are being carried out across the country, particularly in San Francisco and Tennessee."

Answered by AI

What is the sample size of this clinical research endeavor?

"This clinical trial is no longer recruiting, having been first posted on February 4th 2019 and most recently modified on August 3rd 2022. Prospective participants can find 450 trials concerning tumors and 1697 studies regarding AO-176 that are currently accepting patients."

Answered by AI

In what ways is AO-176 commonly employed?

"AO-176 is frequently prescribed to patients with unresectable melanoma, but also for those that have a higher risk of recurrence due to microsatellite instability high."

Answered by AI

Is enrollment for this research study still open?

"According to clinicaltrials.gov, this medical trial is not actively accepting participants as it was last updated on August 3rd 2022. However, there are an abundance of other trials currently recruiting patients - totalling 2147 in number."

Answered by AI

Is the research initiative being conducted across multiple locations in America?

"Currently, 9 clinical trial sites are accepting patient enrolment. These locations can be found in San Francisco, Nashville and Boston along with other cities across the country. To reduce travel costs, it is recommended to select a site close by when signing up for the study."

Answered by AI

Recent research and studies

The Journal of ImmunologyJournal

Novel Sirpα Antibodies That Induce Single-agent Phagocytosis of Tumor Cells While Preserving T Cells

Andrejeva, Gabriela, Benjamin J. Capoccia, Ronald R. Hiebsch, Michael J. Donio, Isra M. Darwech, Robyn J. Puro, and Daniel S. Pereira. 2021. “Novel Sirpα Antibodies That Induce Single-agent Phagocytosis of Tumor Cells While Preserving T Cells”. The Journal of Immunology. The American Association of Immunologists. doi:10.4049/jimmunol.2001019.

clinicaltrials.govStudy

AO-176 in Multiple Solid Tumor Malignancies

2019. "AO-176 in Multiple Solid Tumor Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03834948.