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AO-176 in Multiple Solid Tumor Malignancies

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ClinicalTrials.gov Identifier: NCT03834948
Recruitment Status : Recruiting
First Posted : February 8, 2019
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Arch Oncology

Brief Summary:
This is a first-in-human, Phase 1 multi-center, open-label, dose escalation and expansion study of AO-176 which will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and clinical effects of AO-176.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: AO-176 Phase 1

Detailed Description:

This study will examine AO-176 monotherapy in patients with select advanced solid tumors for which standard therapy proven to provide clinical benefit does not exist or is no longer effective.

The study utilizes a classic 3+3 design, with enrollment of 3 patients per cohort and expansion of the cohort in the event of a DLT. There will be up to 30 patients treated during dose escalation.

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

Each dose escalation cohort will recruit 3 patients to receive AO-176 in a standard 3+3 design.

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.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Multicenter, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of AO-176
Actual Study Start Date : February 4, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : July 2021

Arm Intervention/treatment
Experimental: AO-176 Dose Escalation
Each dose escalation cohort will recruit 3 patients to receive AO-176 in standard 3+3 design.
Drug: AO-176
Humanized mAb targeting CD47

Experimental: AO-176 Dose Expansion
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.
Drug: AO-176
Humanized mAb targeting CD47




Primary Outcome Measures :
  1. Safety Of AO-176 assessed by adverse events and laboratory abnormalities [ Time Frame: Up to 12 months ]
    Evaluate the safety of AO-176 measured by the number adverse events, serious adverse events and lab abnormalities.


Secondary Outcome Measures :
  1. AO-176 Anti-Tumor Activity assessed by changes in response criteria [ Time Frame: Up to 12 months ]
    Evaluate Objective response rate of AO-176 using RECIST and iRECIST.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Select advanced solid tumor for which standard therapy proven to provide clinical benefit does not exist, or is no longer effective.
  2. Measurable disease
  3. ECOG status 0-1
  4. Resolution of prior-therapy-related adverse effects
  5. Minimum of 2 weeks since last dose of cancer therapy

Exclusion Criteria:

  1. Previous hypersensitivity reaction to treatment with another monoclonal antibody.
  2. Prior treatment with a Check Point Inhibitor (anti-PD-1, PD-L1, CTLA-4 etc.) within 4 weeks.
  3. Prior treatment with a CD47 targeted therapy
  4. Prior organ or stem cell transplant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03834948


Contacts
Contact: Liz Wieland, MA 8052085232 ewieland@archoncology.com
Contact: Vernon Phan, PhD vphan@archoncology.com

Locations
United States, Tennessee
Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
Contact    615-339-4214    asksarah@sarahcannon.com   
Sponsors and Collaborators
Arch Oncology
Investigators
Study Director: Jackie Walling, MBChB, PhD Arch Oncology

Additional Information:
Responsible Party: Arch Oncology
ClinicalTrials.gov Identifier: NCT03834948     History of Changes
Other Study ID Numbers: 139454
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Arch Oncology:
CD47
AO-176
Immunotherapy