ENB003 Plus Pembrolizumab Phase 1b/2a in Solid Tumors

StatusUnknown
PhasePhase 1/2
Started

Record status This record was last updated September 19, 2024 (before its estimated January 1, 2026 completion). Its status may not reflect the trial's current state.

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Active, Not Recruiting
  2. Re-verified, no change to tracked fieldsv4
  3. Primary completion date: Apr 30, 2024 to Jan 1, 2026v3 Show 9 more changesShow less
    • Primary endpoints: 2 to 3
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: 130 to 137
    • Study sites: 4 to 5
    • Study completion date: Oct 31, 2024 to Mar 31, 2026
    • Eligibility criteria expanded, about 230 words
    • Secondary endpoints: 8 to 12
    • Study description expanded, about 18 words
    • Study arms: 6 to 7
  4. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Sep 30, 2023 to Apr 30, 2024
    • Study sites: 0 to 4
    • Study completion date: Nov 30, 2023 to Oct 31, 2024
    • Start date changed from estimate of Jan 18, 2020 to Feb 18, 2020
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
First-in Human study evaluating the safety, tolerability and efficacy of ENB003 in combination with Pembrolizumab in solid tumors. The study is separated into two parts. Part A is a 3+3 dose escalation to define the recommended RP2D; this part will include metastatic melanoma, platinum resistant ovarian cancer, and pancreatic cancer patients subjects, but other solid tumors will be allowed. Once the RP2D is selected, the study will be expanded into metastatic melanoma, platinum resistant ovarian cancer, and pancreatic cancer subjects. A small number of sarcoma subjects will be included, as exploratory.
Trial Details
NCT Number NCT04205227
Lead Sponsor ENB Therapeutics, Inc
Collaborators: Merck Sharp & Dohme LLC
Conditions
(from sponsor)		 Cancer, Melanoma, Ovary Cancer, Pancreatic Cancer, Solid Tumor
Related terms Melanoma, Neoplasms, Ovarian Neoplasms, Pancreatic Neoplasms
Enrollment 137 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov