NCT04930354

ECP-1014 Treatment for Patients With Solid Tumor Cancers

A Phase 1 Open-Label, Multiple Dose, Two Part Dose Escalation Study of ECP-1014 as a Treatment for Patients With Solid Tumor Cancers

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: Euclises Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the safety, tolerability, pharmacokinetics, and optimal recommended Phase 2 dose (RP2D) during a 28-day dosing period of ECP-1014 in patients with solid tumors and by evaluation of dose limiting toxicities.

Detailed description

This is a single arm, single-center, open-label, ascending dose study in which dose escalation will be determined based on safety and tolerability. Up to a total of 6 cohorts of patients will be enrolled unless additional intermediate doses are studied, not to exceed the maximal dose per protocol. There are 2 Parts to this study. * Part 1 involves enrolling sequential cohorts of patients into a dose-escalation design, in which doses are assessed for safety/tolerability. * Part 2 involves randomizing a cohort of patients to the highest and second-highest tolerated doses as identified in Part 1.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	ECP-1014	Patients will be selected who (1) have failed all standard of care therapy (relapsed/refractory) or (2) have relapsed and are not a candidate for an available standard of care therapy as assessed by the investigator (such as, but not limited to, colorectal cancer (CRC), Non-Small Cell Lung Cancer (NSCLC), head and neck, etc.) with COX-2 overexpression, ultimately resulting in elevated production of prostaglandin E2 (PGE2).

Timeline

• Start date: 2023-05-01
• Primary completion: 2023-09-01
• Completion: 2023-12-01
• First posted: 2021-06-18
• Last updated: 2023-02-16

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study