Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Pancreatic Neoplasms

Ovarian Neoplasms

Melanoma

Endocrine Gland Neoplasms

Endocrine System Diseases

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Gonadal Disorders

Pancreatic Cancer

Ovarian Cancer

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

150 ug ENB003 will be administered in combination with a fixed dose of pembrolizumab (200mg)

300 ug ENB003 will be administered in combination with a fixed dose of pembrolizumab (200mg)

500 ug ENB003 will be administered in combination with a fixed dose of pembrolizumab (200mg)

750 ug ENB003 will be administered in combination with a fixed dose of pembrolizumab (200mg)

1000 ug ENB003 will be administered in combination with a fixed dose of pembrolizumab (200mg)

2000 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

The 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)

ENB003 is selective Endothelin B Receptor Antagonist

ENB003

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.

Part A: Dose Escalation (with Run-in) A 7-day run-in period of ENB-003 monotherapy, will be administered to all Part A subjects on Days -7, -5 and -3, prior to initiating combination therapy with pembrolizumab at Day 1. ENB-003 will also be administered on Days 1, 3 and 5 in Cycle 1. In subsequent cycles, ENB-003 will be administered on Days 1, 3, 5, 8, 10, and 12 of alternate 21-day treatment cycles, starting with Cycle 3.

Dose escalation will follow a standard 3+3 design, with the following doses being administered during Part A:

* 150 µg ENB-003
* 300 µg ENB-003
* 500 µg ENB-003
* 750 µg ENB-003
* 1000 µg ENB-003 and 2000 µg ENB-003. For 2000 µg doses and above, ENB003 will be administered every 21 day cycle.

Pembrolizumab will be administered as 200 mg on Day 1 of each 21-day cycle in all Part A cohorts.

Part B: Dose Expansion Twelve (12) subjects with malignant melanoma, ovarian cancer, or pancreatic cancer will receive 1 x 21-day treatment cycle of ENB-003 at the recommended phase 2 dose (RP2D) selected in Part A + pembrolizumab. If dose limiting toxicities (DLT) occur in no more than 3 subjects , Part B will be expanded with an additional 27 subjects, plus 6 additional subjects with sarcoma. A review of efficacy will be conducted by a Data Safety Monitoring Board (DSMB) in Part B once 39 RP2D subjects (including 9 malignant melanoma subjects, 16 ovarian cancer subjects and 14 pancreatic cancer subjects) have completed their scheduled 12 week CT/MRI scans. Upon approval by the DSMB, a maximum of 64 further subjects will be treated at the RP2D.

3+3 Dose Escalation and Open Label Expansion

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

A Phase 1/2A Trial of ENB 003 in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

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

Melanoma and Ovarian Cancer:

• ORR, based on RECIST (evaluated in the context of ETBR expression)

Pancreatic Cancer:

• 6-months OS (evaluated in the context of ETBR expression) Note, these outcomes will be measured by tumor type and not in an aggregate as both the futility and final analysis are independently powered for each tumor type

defined as time from first dosing to date of first observed progression, based on RECIST, or death from any cause (whichever comes first).

defined as time from first dosing to date of first observed progression, based on RECIST

defined as time from first dosing to date of death

AUC, measured through blood samples from 0 up to 8 hrs, for all subjects in the dose escalation and the first 12 subjects in the dose expansion

Cmax, measured through blood samples from 0 up to 8 hrs, for all subjects in the dose escalation and the first 12 subjects in the dose expansion

Tmax, measured through blood samples from 0 up to 8 hrs, for all subjects in the dose escalation and the first 12 subjects in the dose expansion

t1/2, measured through blood samples from 0 up to 8 hrs, for all subjects in the dose escalation and the first 12 subjects in the dose expansion

Vss measured through blood samples from 0 up to 8 hrs, for all subjects in the dose escalation and the first 12 subjects in the dose expansion

CL measured through blood samples from 0 up to 8 hrs, for all subjects in the dose escalation and the first 12 subjects in the dose expansion

changes in immunohistochemistry (IHC) for Endothelin B Receptor (ETBR) based on tissue staining measured as a percent of the tissue sample stained, after administration of ENB-003 in combination with pembrolizumab (for subjects with accessible tumors, in whom biopsies can be safely performed).

changes in immunohistochemistry (IHC) for PDL-1 receptor based on tissue staining measured as a percent of the tissue sample stained, after administration of ENB-003 in combination with pembrolizumab (for subjects with accessible tumors, in whom biopsies can be safely performed).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
ENB003 Plus Pembrolizumab Phase 1b/2a in Solid Tumors	NCT04205227	Cancer Melanoma Ovary Cancer Pancreatic Canc... Solid Tumor	ENB003 Pembrolizumab	18 Years - 80 Years	ENB Therapeutics, Inc
ENB003 Plus Pembrolizumab Phase 1b/2a in Solid Tumors	NCT04205227	Cancer Melanoma Ovary Cancer Pancreatic Canc... Solid Tumor	ENB003 Pembrolizumab	18 Years - 80 Years	ENB Therapeutics, Inc

Spots Global Cancer Trial Database for enb003

Every month we try and update this database with for enb003 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for enb003

Every month we try and update this database with for enb003 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for enb003 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.