Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
estimated completion
Principal Investigator
by Pamela Munster, MD (ucsf)
Photo of Pamela Munster
Pamela Munster

Description

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.

Official Title

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

Details

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.

Keywords

Solid Tumor CD47 AO-176 Immunotherapy Paclitaxel AO-176 + Paclitaxel AO-176 Dose Escalation AO-176 Dose Expansion AO-176 + Paclitaxel Dose Escalation AO-176 + Paclitaxel Dose Expansion

Eligibility

You can join if…

Open to people ages 18 years and up

  1. 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

You CAN'T join if...

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

Locations

  • University of California San Francisco accepting new patients
    San Francisco California 94143 United States
  • University of Southern California accepting new patients
    Los Angeles California 90033 United States

Lead Scientist at UC Health

  • Pamela Munster, MD (ucsf)
    Professor, Medicine. Authored (or co-authored) 126 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Arch Oncology
Links
Arch Oncology website
ID
NCT03834948
Phase
Phase 1/2
Study Type
Interventional
Last Updated