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AO-176 in Multiple Solid Tumor Malignancies

Trial Status: Active

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.

Inclusion Criteria

  • Select advanced solid tumor for which standard therapy proven to provide clinical benefit does not exist, or is no longer effective Part A:
  • Epithelial ovarian carcinoma (EOC)
  • Endometrial carcinoma
  • Castration resistant prostate cancer
  • Non-small cell lung adenocarcinoma
  • Papillary thyroid carcinoma
  • Malignant mesothelioma (pleural or peritoneal)
  • Gastroesophageal adenocarcinoma
  • Squamous cell carcinoma of the head and neck Part B:
  • Platinum-resistant EOC (including fallopian tube or primary peritoneal cancer)
  • Endometrial carcinoma
  • Gastric adenocarcinoma/gastroesophageal adenocarcinoma
  • Measurable disease
  • ECOG status 0-1
  • Resolution of prior-therapy-related adverse effects
  • Minimum of 3 weeks or 5 half-lives since last dose of cancer therapy

Exclusion Criteria

  • Previous hypersensitivity reaction to treatment with another monoclonal antibody
  • Unresolved hypersensitivity to paclitaxel or any of its excipients (Part B only). Patients who have been desensitized may participate.
  • Prior treatment with a checkpoint inhibitor (anti-PD-1, PD-L1, CTLA-4 etc.) within 4 weeks prior to the start of study drug
  • Prior treatment with a CD47-targeted therapy
  • Prior organ or stem cell transplant

California

Los Angeles
Los Angeles County-USC Medical Center
Status: ACTIVE
Contact: Xiomara Menendez
Phone: 323-865-0212
USC / Norris Comprehensive Cancer Center
Status: ACTIVE
Contact: Jessica Levano
Phone: 323-865-0593
Newport Beach
Hoag Memorial Hospital
Status: ACTIVE
Contact: Cristina de Leon
Phone: 949-764-5543
San Francisco
UCSF Medical Center-Mount Zion
Status: ACTIVE
Contact: UCSF Clinical Trials
Phone: 877-827-3222

Massachusetts

Boston
Brigham and Women's Hospital
Status: ACTIVE
Dana-Farber Cancer Institute
Status: ACTIVE
Massachusetts General Hospital Cancer Center
Status: ACTIVE

Oregon

Portland
OHSU Knight Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Jacqueline Vuky
Phone: 971-262-9600

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, including epithelial ovarian carcinoma (EOC), which will include primary peritoneal and fallopian tube carcinoma; squamous cell carcinoma of the 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. Part B of this study will examine escalating repeat doses of AO-176 in combination with paclitaxel in platinum-resistant EOC, including primary peritoneal and fallopian tube carcinoma; endometrial carcinoma; and gastric adenocarcinoma/gastroesophageal adenocarcinoma. The monotherapy and combination Dose Escalation portions of the study utilize 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 in dose escalation, tumor-specific dose expansion cohorts will be recruited to further assess safety and evaluate preliminary efficacy of AO-176 as monotherapy and in combination with paclitaxel.

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
Arch Oncology

  • Primary ID AO-176-101
  • Secondary IDs NCI-2019-02526, 139454
  • Clinicaltrials.gov ID NCT03834948