A Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants With Advanced Malignancies

  • STATUS
    Not Recruiting
  • End date
    Sep 30, 2021
  • participants needed
    44
  • sponsor
    Arcus Biosciences, Inc.
Updated on 17 February 2021
cancer
combinations
measurable disease
carcinoma
breast cancer
squamous cell carcinoma
lung cancer
ovarian cancer
breast carcinoma
bladder cancer
taxane
sipuleucel-t
core needle biopsy
colorectal neoplasm
endometrial carcinoma
cancer of the ovary
cytotoxic t-lymphocyte antigen 4
ab122
squamous cell cancers

Summary

This is a Phase 1, open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and clinical activity of AB928 in combination with AB122 (an anti-PD-1 antibody) in participants with advanced malignancies.

Description

In the dose-escalation phase, escalating doses of AB928 in combination with AB122 will be assessed in participants with advanced malignancies. Eligible participants will receive oral administration of AB928 as well as IV infusion of AB122. The recommended dose for expansion (RDE) of AB928 will be determined upon completion of the dose-escalation phase.

In the dose-expansion phase, AB928 at RDE in combination with AB122 may be assessed in participants with advanced clear-cell renal cell carcinoma (RCC) or metastatic castrate-resistant adenocarcinoma of the prostate (mCRPC).

Overall duration of treatment will depend on how well the treatment is tolerated. Treatment may continue until unacceptable toxicity or progressive disease or other reasons specified in the protocol.

Details
Condition Non-Small Cell Lung Cancer, Adenocarcinoma, urinary tract neoplasm, Ovarian disorder, Colorectal Cancer, Endometrial Carcinoma, Malignant neoplasm of kidney, Rectal disorder, Neuroendocrine carcinoma, Uterine Cancer, bladder cancer, bladder disorder, Breast Cancer, Ovarian Cancer, melanoma, Renal Cell Carcinoma, skin cancer, Merkel cell carcinoma, Metastatic Melanoma, Colon Cancer Screening, Rectal Disorders, Colon cancer; rectal cancer, Ovarian Function, Squamous Cell Carcinoma of the Head and Neck, Urothelial Cancer, Gastroesophageal Cancer, Recurrent Ovarian Cancer, Castration Resistant Prostate Cancer, Kidney Cancer, Endometrial Cancer, Malignant Melanoma, Malignant Adenoma, Bladder Disorders, Renal Cell Cancer, Renal Cancer, Bladder Carcinoma, Urologic Cancer
Treatment AB928, AB122
Clinical Study IdentifierNCT03629756
SponsorArcus Biosciences, Inc.
Last Modified on17 February 2021

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