NCT03525795

ORIOn-E: A Study Evaluating CPI-1205 in Patients With Advanced Solid Tumors

Completed Phase 1 Last updated 18 May 2022

What this trial tests

Phase 1 trial testing CPI-1205 in Advanced Solid Tumors in 24 participants. Completed in 12 June 2019.

Timeline

14 December 2017

Primary endpoint
12 June 2019

12 June 2019

Quick facts

Lead sponsor	Constellation Pharmaceuticals
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	14 December 2017
Primary completion	12 June 2019
Estimated completion	12 June 2019
Sites	3 locations across United States

Drugs / interventions tested

• CPI-1205 — full drug profile →
• ipilimumab — full drug profile →

Conditions studied

• Advanced Solid Tumors — all drugs for Advanced Solid Tumors →

Sponsor

Constellation Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Advanced Solid Tumors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase 1/2, multi-center, open-label study of CPI-1205 + ipilimumab in patients with histologically or cytologically confirmed advanced solid tumors. This study is designed to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of CPI-1205 + ipilimumab in patients with advanced solid tumors. Patients in Phase 2 will be treated at the RP2D of CPI-1205 + ipilimumab.

This study was stopped prior to proceeding to Phase 2; no patients were enrolled in Phase 2.

Publications & conference data

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

1. Targeting epigenetic regulators for cancer therapy: mechanisms and advances in clinical trials.
   Cheng Y, He C, Wang M, Ma X, et al · · 2019 · cited 760× · PMID 31871779 · DOI 10.1038/s41392-019-0095-0
2. EZH2: a novel target for cancer treatment.
   Duan R, Du W, Guo W. · · 2020 · cited 652× · PMID 32723346 · DOI 10.1186/s13045-020-00937-8
3. Tumor biomarkers for diagnosis, prognosis and targeted therapy.
   Zhou Y, Tao L, Qiu J, Xu J, et al · · 2024 · cited 379× · PMID 38763973 · DOI 10.1038/s41392-024-01823-2
4. Epigenetic regulation in the tumor microenvironment: molecular mechanisms and therapeutic targets.
   Yang J, Xu J, Wang W, Zhang B, et al · · 2023 · cited 251× · PMID 37217462 · DOI 10.1038/s41392-023-01480-x
5. Multi-omics analysis identifies therapeutic vulnerabilities in triple-negative breast cancer subtypes.
   Lehmann BD, Colaprico A, Silva TC, Chen J, et al · · 2021 · cited 197× · PMID 34725325 · DOI 10.1038/s41467-021-26502-6
6. EZH2-Targeted Therapies in Cancer: Hype or a Reality.
   Eich ML, Athar M, Ferguson JE, Varambally S. · · 2020 · cited 188× · PMID 32978169 · DOI 10.1158/0008-5472.can-20-2147
7. Epigenetics and beyond: targeting writers of protein lysine methylation to treat disease.
   Bhat KP, Ümit Kaniskan H, Jin J, Gozani O. · · 2021 · cited 181× · PMID 33469207 · DOI 10.1038/s41573-020-00108-x
8. N-Myc-mediated epigenetic reprogramming drives lineage plasticity in advanced prostate cancer.
   Berger A, Brady NJ, Bareja R, Robinson B, et al · · 2019 · cited 157× · PMID 31260412 · DOI 10.1172/jci127961