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Trial record 1 of 1 for:    NCT03834948
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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 : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
Arch Oncology

Tracking Information
First Submitted Date  ICMJE February 4, 2019
First Posted Date  ICMJE February 8, 2019
Last Update Posted Date June 23, 2020
Actual Study Start Date  ICMJE February 4, 2019
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2020)
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 v1.1 and iRECIST.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2019)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AO-176 in Multiple Solid Tumor Malignancies
Official Title  ICMJE A Phase 1/2 Multicenter, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AO-176
Brief Summary This is a first-in-human, Phase 1/2 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 in patients with advanced solid tumors.
Detailed Description

This is a first-in-human, Phase 1/2 multicenter, open-label, dose escalation and expansion study of AO-176 in patients with solid tumors. Part A of this study will examine escalating repeat doses of AO-176 monotherapy in patients with select advanced solid tumors (epithelial ovarian carcinoma, including primary peritoneal and fallopian tube carcinoma, squamous cell carcinoma of head and neck, endometrial carcinoma, castration resistant prostate cancer, non-small cell lung adenocarcinoma, papillary thyroid carcinoma, pleural or peritoneal malignant mesothelioma and gastroesophageal adenocarcinoma) 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 dose-limiting toxicity (DLT).

Once the maximum-tolerated dose (MTD)/recommended phase 2 dose (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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

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

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
Condition  ICMJE Solid Tumor
Intervention  ICMJE Drug: AO-176
Humanized monoclonal antibody (mAb) targeting CD47
Study Arms  ICMJE
  • Experimental: AO-176 Dose Escalation
    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.
    Intervention: Drug: AO-176
  • 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.
    Intervention: Drug: AO-176
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 6, 2019)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key 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 3 weeks or 5 half-lives since last dose of cancer therapy

Key Exclusion Criteria:

  1. Previous hypersensitivity reaction to treatment with another monoclonal antibody
  2. Prior treatment with a checkpoint 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kevin Romanko, DPM 4156714028 kromanko@archoncology.com
Contact: Amy Douglas adouglas@archoncology.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03834948
Other Study ID Numbers  ICMJE AO-176-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Arch Oncology
Study Sponsor  ICMJE Arch Oncology
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jackie Walling, MBChB, PhD Arch Oncology
PRS Account Arch Oncology
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP