Clinical Trials /

AO-176 in Multiple Solid Tumor Malignancies

NCT03834948

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: AO-176 in Multiple Solid Tumor Malignancies
  • 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

Clinical Trial IDs

  • ORG STUDY ID: 139454
  • NCT ID: NCT03834948

Conditions

  • Solid Tumor

Interventions

DrugSynonymsArms
AO-176AO-176 Dose Escalation

Purpose

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
AO-176 Dose EscalationExperimentalEach dose escalation cohort will recruit 3 patients to receive AO-176 in standard 3+3 design.
  • AO-176
AO-176 Dose ExpansionExperimentalOnce 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.
  • AO-176

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Safety Of AO-176 assessed by adverse events and laboratory abnormalities
Time Frame:Up to 12 months
Safety Issue:
Description:Evaluate the safety of AO-176 measured by the number adverse events, serious adverse events and lab abnormalities.

Secondary Outcome Measures

Measure:AO-176 Anti-Tumor Activity assessed by changes in response criteria
Time Frame:Up to 12 months
Safety Issue:
Description:Evaluate Objective response rate of AO-176 using RECIST and iRECIST.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Arch Oncology

Trial Keywords

  • CD47
  • AO-176
  • Immunotherapy

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