NCT03454451

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

Completed Phase 1 Last updated 21 December 2023

What this trial tests

Phase 1 trial testing CPI-006 in Non-Small Cell Lung Cancer in 117 participants. Completed in 19 February 2023.

Timeline

25 April 2018

Primary endpoint
28 December 2022

19 February 2023

Quick facts

Lead sponsor	Corvus Pharmaceuticals, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	117
Start date	25 April 2018
Primary completion	28 December 2022
Estimated completion	19 February 2023
Sites	27 locations across United States, Australia

Drugs / interventions tested

• CPI-006 — full drug profile →
• CPI-006 + ciforadenant — full drug profile →
• CPI-006 + pembrolizumab — full drug profile →
• CPI-006 — full drug profile →
• CPI-006 + ciforadenant — full drug profile →
• CPI-006 + pembrolizumab — full drug profile →

Conditions studied

• Non-Small Cell Lung Cancer — all drugs for Non-Small Cell Lung Cancer →
• Renal Cell Cancer — all drugs for Renal Cell Cancer →
• Colorectal Cancer — all drugs for Colorectal Cancer →
• Triple Negative Breast Cancer — all drugs for Triple Negative Breast Cancer →

Sponsor

Corvus Pharmaceuticals, Inc. — full company profile →

Who can join

18 and older, any sex, with Non-Small Cell Lung Cancer or Renal Cell Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The tumour microenvironment in pancreatic cancer - clinical challenges and opportunities.
   Ho WJ, Jaffee EM, Zheng L. · · 2020 · cited 963× · PMID 32398706 · DOI 10.1038/s41571-020-0363-5
2. Myeloid-derived suppressor cells as immunosuppressive regulators and therapeutic targets in cancer.
   Li K, Shi H, Zhang B, Ou X, et al · · 2021 · cited 687× · PMID 34620838 · DOI 10.1038/s41392-021-00670-9
3. Natural killer cells in antitumour adoptive cell immunotherapy.
   Laskowski TJ, Biederstädt A, Rezvani K. · · 2022 · cited 547× · PMID 35879429 · DOI 10.1038/s41568-022-00491-0
4. Next generation of immune checkpoint inhibitors and beyond.
   Marin-Acevedo JA, Kimbrough EO, Lou Y. · · 2021 · cited 401× · PMID 33741032 · DOI 10.1186/s13045-021-01056-8
5. Advancements in clinical aspects of targeted therapy and immunotherapy in breast cancer.
   Ye F, Dewanjee S, Li Y, Jha NK, et al · · 2023 · cited 361× · PMID 37415164 · DOI 10.1186/s12943-023-01805-y
6. Emerging therapies for glioblastoma: current state and future directions.
   Rong L, Li N, Zhang Z. · · 2022 · cited 351× · PMID 35428347 · DOI 10.1186/s13046-022-02349-7
7. Targeting Adenosine in Cancer Immunotherapy to Enhance T-Cell Function.
   Vigano S, Alatzoglou D, Irving M, Ménétrier-Caux C, et al · · 2019 · cited 326× · PMID 31244820 · DOI 10.3389/fimmu.2019.00925
8. Cervical Cancer Immunotherapy: Facts and Hopes.
   Ferrall L, Lin KY, Roden RBS, Hung CF, et al · · 2021 · cited 255× · PMID 33888488 · DOI 10.1158/1078-0432.ccr-20-2833