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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

Description

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, 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.

Phase

N/A

Inclusion and Exclusion Criteria

  • Key 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 Key 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

Sites

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