CPI-006 Alone and in Combination With Ciforadenant and With Pembrolizumab for Patients With Advanced Cancers

  • STATUS
    Recruiting
  • End date
    Dec 4, 2023
  • participants needed
    378
  • sponsor
    Corvus Pharmaceuticals, Inc.
Updated on 4 February 2021
cancer
monoclonal antibodies
measurable disease
breast cancer
lung cancer
pembrolizumab
solid tumour
triple negative breast cancer
bladder cancer
sarcoma
bladder tumor
colorectal neoplasm
lung carcinoma

Summary

This is a Phase 1/1b open-label, dose escalation and dose expansion study of CPI-006, a humanized monoclonal antibody (mAb) targeting the CD73 cell-surface ectonucleotidase in adult subjects with select advanced cancers. CPI-006 will be evaluated as a single agent, in combination with ciforadenant (an oral adenosine 2A receptor antagonist), in combination with pembrolizumab (an anti-PD1 antibody), and in combination with ciforadenant and pembrolizumab.

Details
Condition Pancreatic Cancer, Non-Small Cell Lung Cancer, Cervical Cancer, Adenocarcinoma, urinary tract neoplasm, Ovarian disorder, Colorectal Cancer, Disorders of cervix NOS, Connective and Soft Tissue Neoplasm, Endometrial Carcinoma, Malignant neoplasm of kidney, Rectal disorder, Uterine Cancer, Lymphoma, Pancreatic disorder, bladder cancer, bladder disorder, Breast Cancer, Ovarian Cancer, Renal Cell Carcinoma, Lymphoma, Neoplasm of unspecified nature of digestive system, Sarcoma, Diet and Nutrition, Chronic Diarrhea, Pancreatic Disorders, Skin Wounds, Chronic Shoulder Pain, Vaginal Atrophy, Non-Hodgkin's Lymphoma, Adverse Effects, Drugs, Injection Port, Breast Cancer - HER2 Positive, All Solid Tumors, Anal Dysplasia, Primary Immunodeficiency, Pediatric Health, Near-Sighted Corrective Surgery, Colon Cancer Screening, Rectal Disorders, Solid Tumors, Colon cancer; rectal cancer, Ovarian Function, Squamous Cell Carcinoma of the Head and Neck, Peripheral Arterial Occlusive Disease, Triple Negative Breast Cancer, Brain Function, Urothelial Cancer, Squamous Cell Carcinoma of Head and Neck, Recurrent Respiratory Papillomatosis, Recurrent Ovarian Cancer, Metastatic Castration Resistant Prostate Cancer, Razor Bumps (Pseudofolliculitis Barbae), Sarcoma (Pediatric), Islet Ce417ll Cancer, Metastatic Triple-Negative Breast Cancer, Kidney Cancer, Endometrial Cancer, Malignant Adenoma, Bladder Disorders, Renal Cell Cancer, Renal Cancer, Digestive System Neoplasms, Soft Tissue Sarcoma, Bladder Carcinoma, Urologic Cancer, cervical carcinoma, colorectal neoplasm, non-hodgkin's lymphoma (nhl), ovarian carcinomas, cancer, ovarian, cancer ovarian, cancer of the ovary, carcinoma of the bladder, sarcomas, soft tissue sarcomas, colorectal cancers, nsclc, cervical cancer, uterine, cancer of the pancreas, carcinoma of the cervix uteri, carcinoma of the cervix, cervix cancer, cancer of the cervix, carcinoma of cervix, ovarian tumors, cancer, renal, pancreatic cancers, cancer, pancreatic, cancer, colorectal, colorectal tumor, tumors, colorectal, bladder tumor
Treatment CPI-006, CPI-006 + CPI-444, CPI-006 + pembrolizumab, CPI-006 + ciforadenant
Clinical Study IdentifierNCT03454451
SponsorCorvus Pharmaceuticals, Inc.
Last Modified on4 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
Documented incurable cancer with one of the following histologies: nonsmall cell lung cancer, renal cell cancer, triple negative breast cancer, colorectal cancer with microsatellite instability(MSI), bladder cancer, cervical cancer, uterine cancer, sarcoma, endometrial cancer, and metastatic castration resistant prostate cancer
At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
For Escalation: At least 1 but not more than 5 prior systemic therapies for advanced/ recurrent or progressing disease. For Expansion: Subject must have progressed on, be refractory to, or intolerant to 1-3 prior systemic therapies
Willingness to provide tumor biopsies

Exclusion Criteria

History of severe hypersensitivity reaction to monoclonal antibodies
Subjects who have received prior therapy with regimens containing cytotoxicT-lymphocyte antigen-4 (CTLA-4), programmed cell death ligand 1 (PDL1), or PD1 antagonists are NOT permitted to enroll unless all adverse events (AEs) while receiving prior immunotherapy have resolved to Grade 1 or baseline prior to screening
History of (non-infectious) pneumonitis that required steroids or subject has current pneumonitis
The use of any investigational medication or device in the 30 days prior to screening and throughout the study is prohibited
Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
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