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

Conditions

• Bladder Cancer
• Cervical Cancer
• Colorectal Cancer
• Endometrial Cancer
• Metastatic Castration Resistant Prostate Cancer
• Non-Small Cell Lung Cancer
• Non-hodgkin Lymphoma
• Ovarian Cancer
• Pancreatic Cancer
• Renal Cell Cancer
• Sarcoma
• Squamous Cell Carcinoma of the Head and Neck
• Triple Negative Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• CPI-006 — DRUG
  Subjects will receive escalating doses of CPI-006 administered intravenously once every 21 days until MTD is reached or until disease progression.
• CPI-006 + ciforadenant — DRUG
  Subjects will receive escalating doses of CPI-006 administered intravenously once every 21 days in combination with CPI-444 orally twice daily until MTD is reached for CPI-006 or until disease progression.
• CPI-006 + pembrolizumab — DRUG
  Subjects will receive escalating doses of CPI-006 in combination with pembrolizumab administered intravenously once every 21 days until MTD is reached for CPI-006 or until disease progression.
• CPI-006 — DRUG
  Selected dose of CPI-006 administered intravenously once every 21 days until disease progression.
• CPI-006 + ciforadenant — DRUG
  Selected dose of CPI-006 administered intravenously once every 21 days, in combination with CPI-444 orally twice daily until disease progression.
• CPI-006 + pembrolizumab — DRUG
  Selected dose of CPI-006 in combination with pembrolizumab administered intravenously once every 21 days until disease progression.

Study Details

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.

Key Dates

First listed

Mar 6, 2018

Start date

Apr 25, 2018

Status verified

Dec 2023

Primary completion

Dec 28, 2022

Completion

Feb 19, 2023

Study Design

Enrollment

117 participants (actual)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1a
  CPI-006
• Experimental: Cohort1b
  CPI-006 + ciforadenant
• Experimental: Cohort 1c
  CPI-006 + pembrolizumab
• Experimental: Cohort 2a
  CPI-006
• Experimental: Cohort 2b
  CPI-006 + ciforadenant
• Experimental: Cohort 2c
  CPI-006 + pembrolizumab

Primary Outcome Measure

Incidence of dose-limiting toxicities (DLTs) of CPI-006 as a single agent and in combination with ciforadenant and with pembrolizumab. [ Time Frame: From start of treatment to end of treatment, up to 36 months ]

Locations (22)

Find similar trials in Tucson, AZ

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