AO-176 in Multiple Solid Tumor Malignancies
Status: | Recruiting |
---|---|
Conditions: | Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/30/2019 |
Start Date: | February 4, 2019 |
End Date: | July 2021 |
Contact: | Liz Wieland, MA |
Email: | ewieland@archoncology.com |
Phone: | 8052085232 |
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
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.
study of AO-176 which will evaluate the safety, tolerability, pharmacokinetics (PK),
pharmacodynamics, and clinical effects of AO-176.
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.
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.
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
We found this trial at
3
sites
8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
Fairfax, Virginia 22031
(703) 280-5390
Principal Investigator: Alex Spira, MD
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
Click here to add this to my saved trials
Los Angeles, California 90033
213) 740-2311
Principal Investigator: Anthony El-Khoueriy, MD
University of Southern California The University of Southern California is one of the world’s leading...
Click here to add this to my saved trials
250 25th Ave N, Ste 100
Nashville, Tennessee 37023
Nashville, Tennessee 37023
615-320-5090
Phone: 615-339-4214
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
Click here to add this to my saved trials