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ENB003

Phase 1

Cancer | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Sep 19, 2024

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment137

FDA Designations

No designations recorded

Clinical trial landscape

ENB003 · 1 trial · 5 indications

Phase 1 1
NCT04205227ENB003 Plus Pembrolizumab Phase 1b/2a in Solid TumorsCancer
ACTIVE NOT_RECRUITING137 Analytics
PHASE1ACTIVE NOT_RECRUITING
ENB003 Plus Pembrolizumab Phase 1b/2a in Solid Tumors
CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Part A: Incidence of Treatment-Emergent Adverse Events of ENB003 in combination with pembrolizumab, as assessed by NCI CTCAE Version 5
assessed on every visit while subjects are in the study up to 2 years

Based on observed or reported AEs. AEs will be evaluated and classified according to NCI CTCAE Version 5.0

Part B: Efficacy of ENB003 in combination with pembrolizumab
up to 2 years while subjects remain in the study

Melanoma and Ovarian Cancer: • ORR, based on RECIST (evaluated in the context of ETBR expression)

Secondary Endpoints

Part B Efficacy Progression-free survival (PFS),
up to 2 years
Part B Efficacy: Duration of response
up to 2 years
Part B Efficacy: Time to progression
up to 2 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ENB003 150 ug + PembrolizumabEXPERIMENTAL150 ug ENB003 will be administered in combination with a fixed dose of pembrolizumab (200mg)
ENB003 300 ug + PembrolizumabEXPERIMENTAL300 ug ENB003 will be administered in combination with a fixed dose of pembrolizumab (200mg)
ENB003 500 ug + PembrolizumabEXPERIMENTAL500 ug ENB003 will be administered in combination with a fixed dose of pembrolizumab (200mg)
ENB003 750 ug + PembrolizumabEXPERIMENTAL750 ug ENB003 will be administered in combination with a fixed dose of pembrolizumab (200mg)
ENB003 1000 ug + PembrolizumabEXPERIMENTAL1000 ug ENB003 will be administered in combination with a fixed dose of pembrolizumab (200mg)
ENB003 2000 ug + PembrolizumabEXPERIMENTAL2000 ug ENB003 will be administered in combination with a fixed dose of pembrolizumab (200mg). In this treatment arm, ENB003 will be administered during each 21 day cycle, as opposed to every other cycle in early arms
ENB003 RP2D from dose escalation + PembrolizumabEXPERIMENTALThe recommended phase 2 dose (RP2D) of ENB003 will be selected from the dose escalation portion of the study and administered in combination with a fixed dose of pembrolizumab (200mg)

Interventions

NameTypeDescription
ENB003DRUGENB003 is selective Endothelin B Receptor Antagonist
PembrolizumabDRUGanti-PD1
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites5

Subjects must fulfill all the following inclusion criteria relevant to their tumor type to be eligible for participation in the study: Inclusion Criteria Malignant Melanoma * Histopathologically confirmed diagnosis of advanced, unresectable or metastatic malignant melanoma. * Subjects may have re...

Countries:United StatesAustralia
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Frequently asked questions about ENB003

What is ENB003 used for?

ENB003 is an investigational small molecule being developed for the treatment of cancer, including melanoma, ovary cancer, pancreatic cancer, and solid tumors. It is currently in Phase 1 clinical development and has not been approved by the FDA.

Who makes ENB003?

ENB003 is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK on the New York Stock Exchange.

What phase is ENB003 in?

ENB003 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. It is being studied in a Phase 1b/2a trial in solid tumors.

What clinical trials is ENB003 in?

ENB003 is being studied in clinical trial NCT04205227, titled 'ENB003 Plus Pembrolizumab Phase 1b/2a in Solid Tumors'. This trial is active but not recruiting, with an enrollment of 137 participants, and is being conducted in the United States and Australia.

Is ENB003 being studied in combination with other drugs?

Yes, ENB003 is being studied in combination with pembrolizumab in a Phase 1b/2a clinical trial for solid tumors. The trial is controlled and biomarker-selected, but it is not randomized or double-blind.