NCT02675946

A Phase 1 Open-label Dose Escalation Study of CGX1321 in Subjects With Advanced Solid Tumors With Expansion in Advanced Gastrointestinal Tumors and Phase 1b Study of CGX1321 in Combination With Pembrolizumab in Subjects With Advanced Colorectal Cancer or in Combination With Encorafenib + Cetuximab in Subjects With BRAFV600E Mutated Advanced Colorectal Cancer

Status unknown Phase 1 Last updated 11 January 2022

What this trial tests

Phase 1 trial testing CGX1321 in Solid Tumors in 72 participants. Status unknown.

Timeline

1 February 2016

Primary endpoint
1 March 2023

1 March 2023

Quick facts

Lead sponsor	Curegenix Inc.
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	72
Start date	1 February 2016
Primary completion	1 March 2023
Estimated completion	1 March 2023
Sites	26 locations across United States, Taiwan

Drugs / interventions tested

• CGX1321 — full drug profile →
• Pembrolizumab (pembrolizumab) — full drug profile →
• encorafenib (encorafenib) — full drug profile →
• cetuximab (cetuximab) — full drug profile →

Conditions studied

• Solid Tumors — all drugs for Solid Tumors →
• GI Cancer — all drugs for GI Cancer →

Sponsor

Curegenix Inc. — full company profile →

Who can join

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

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of participants with adverse events and/or abnormal laboratory values that are related to treatment
  Time frame: 55 months
  safety

Sponsor's own description

This is a multicenter, open-label study conducted in two phases: Phase 1 consisting of a CGX1321 Single Agent Dose Escalation Phase in solid tumors, CGX1321 Single Agent Dose Expansion Phase in GI tumors and Roll-over Cohort of CGX1321 and pembrolizumab in subjects who have progressed on single agent CGX1321 and Phase 1b consisting of CGX1321 in combination with pembrolizumab in colorectal tumors and CGX1321 in combination with encorafenib + cetuximab in BRAFV600E mutated colorectal tumors. Both phases are to evaluate safety, pharmacokinetics, and clinical activity.

Publications & conference data

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

1. Targeting the Wnt/β-catenin signaling pathway in cancer.
   Zhang Y, Wang X. · · 2020 · cited 1065× · PMID 33276800 · DOI 10.1186/s13045-020-00990-3
2. Wnt/β-catenin signaling in cancers and targeted therapies.
   Yu F, Yu C, Li F, Zuo Y, et al · · 2021 · cited 565× · PMID 34456337 · DOI 10.1038/s41392-021-00701-5
3. Wnt/beta-catenin pathway: modulating anticancer immune response.
   Pai SG, Carneiro BA, Mota JM, Costa R, et al · · 2017 · cited 511× · PMID 28476164 · DOI 10.1186/s13045-017-0471-6
4. Wnt signaling in breast cancer: biological mechanisms, challenges and opportunities.
   Xu X, Zhang M, Xu F, Jiang S. · · 2020 · cited 450× · PMID 33234169 · DOI 10.1186/s12943-020-01276-5
5. Wnt signaling in cancer: therapeutic targeting of Wnt signaling beyond β-catenin and the destruction complex.
   Jung YS, Park JI. · · 2020 · cited 335× · PMID 32037398 · DOI 10.1038/s12276-020-0380-6
6. Immune checkpoint inhibitors for the treatment of MSI-H/MMR-D colorectal cancer and a perspective on resistance mechanisms.
   Sahin IH, Akce M, Alese O, Shaib W, et al · · 2019 · cited 296× · PMID 31607751 · DOI 10.1038/s41416-019-0599-y
7. WNT/β-Catenin Signaling Pathway Regulating T Cell-Inflammation in the Tumor Microenvironment.
   Li X, Xiang Y, Li F, Yin C, et al · · 2019 · cited 209× · PMID 31616443 · DOI 10.3389/fimmu.2019.02293
8. WNT Signaling in Melanoma.
   Gajos-Michniewicz A, Czyz M. · · 2020 · cited 175× · PMID 32659938 · DOI 10.3390/ijms21144852