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CancerPhase 1/2NCT04205227

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

A Phase 1/2 study testing ENB003 and Pembrolizumab in people with Cancer and Melanoma, run by ENB Therapeutics, Inc at 5 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Cancer, Melanoma, Ovary Cancer
What is being tested?
ENB003 and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
137 participants
Where
5 sitesin 2 countries
Study dates
18 Feb 2020to 31 Mar 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Malignant Melanoma
  • Histopathologically confirmed diagnosis of advanced, unresectable or metastatic malignant melanoma.
  • Subjects may have received no more than 3 previous lines of systemic anti-cancer therapy for advanced disease.
  • Subjects must have progressed on treatment with an anti-PD1/Ligand 1 (L1) monoclonal antibody (mAb) administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies. PD-1 treatment progression as defined by meeting all of the following criteria:
  • Has at least six weeks of anti PD-1/L1 exposure with an approved anti-PD-1/L1 mAb.
  • Has a best objective response (according to RECIST) of PD or SD < 6 months. If RECIST not performed, must be determined to have clinical progression within 6 months of initial treatment with anti-PD1 / PD-L1.
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  • Ovarian Cancer
  • Histologically proven diagnosis of high grade serous, high grade endometroid or clear cell ovarian cancer, fallopian tube or primary peritoneal carcinoma.
  • Platinum refractory disease, defined as PD during the administration period of first-line platinum-based chemotherapy. Platinum resistant disease defined as PD within 6 months (182 days) after last receipt of first-line platinum-based chemotherapy.
  • Subjects may have received up to 3 previous lines of systemic anti-cancer therapy for advanced disease.
  • Ovarian cancer patients must be tested for the MSI phenotype. If subjects have high microsatellite instability (MSI-H) or mismatch-repair deficiency (dMMR) phenotype they must have been previously treated with anti-PD1 and demonstrated either PD or disease stabilization, for less than 6 months as best response.
  • Pancreatic Cancer
  • Histologically confirmed (previously obtained biopsied) metastatic or locally advanced unresectable pancreatic adenocarcinoma or pancreatic adenocarcinoma that is recurrent after resection, including with intraductal papillary mucinous neoplasm.
  • Subjects must have previously received and progressed on FOLFIRINOX or a gemcitabine-based regimen for their pancreatic cancer.
  • Subjects may have received no more than 2 previous lines of therapy for advanced/metastatic disease.
  • Pancreatic cancer patients must be tested for the MSI phenotype. If subjects have high microsatellite instability (MSI-H) or mismatch-repair deficiency (dMMR) phenotype they must have been previously treated with anti-PD1 and demonstrated either PD or disease stabilization for less than 6 months as best response.
  • Basket Study:
  • The first 10 subjects for each indication must be ETBR+.
  • Subjects must have progressed on at least one standard of care therapy and must not have received more than 3 prior systemic therapies.
  • SCC of the Head and Neck
  • Histologically confirmed metastatic SCC of the head and neck.
  • Subjects must have progressed on treatment with an anti-PD1/Ligand 1 (L1) monoclonal antibody (mAb) administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies. PD-1 treatment progression as defined by meeting all of the following criteria:
  • Has at least six weeks of anti PD-1/L1 exposure with an approved anti-PD-1/L1 mAb.
  • Has a best objective response (according to RECIST) of PD or SD < 6 months
  • If RECIST not performed, must be determined to have clinical progression within 6 months of initial treatment with anti-PD1 / PD-L1.
  • Triple Negative Breast Cancer
  • Histologically proven diagnosis of metastatic TNBC
  • TNBC subjects must be tested for PD-L1 expression. For CPS >10, Subjects must have progressed on treatment with an anti-PD1/Ligand 1 (L1) monoclonal antibody (mAb) administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies. PD-1 treatment progression as defined by meeting all of the following criteria:
  • Has at least six weeks of anti PD-1/L1 exposure with an approved anti-PD-1/L1 mAb.
  • Has a best objective response (according to RECIST) of PD or SD < 6 months. If RECIST not performed, must be determined to have clinical progression within 6 months of initial treatment with anti-PD1 / PD-L1.
  • All Subjects:
  • Be willing and able to provide written informed consent for the trial.
  • Be ≥18 years of age on day of signing informed consent.
  • Has a life expectancy of >3 months.
  • Must have confirmed slides or a tumor block available prior to dosing.
  • Fresh biopsies for ETBR and biomarker analysis are preferred for all subjects, especially those that have superficial (cutaneous or subcutaneous e.g. lymph nodes) primary or metastatic lesions. If obtaining a fresh biopsy is not possible, subjects must have archival tumor tissue obtained within 24 months of Screening and that is suitable for performing IHC and biomarker analyses.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
  • Not a woman of childbearing potential (WOCBP), where a WOCBP is defined as:
  • Not surgically sterile i.e. bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy, or
  • Not post-menopausal, defined as amenorrhea for ≥ 2 years without an alternative medical cause.
  • Note: Women with amenorrhea for < 2 years and who are not surgically sterile i.e. tubal ligation, bilateral oophorectomy, or complete hysterectomy will only be considered not to be of reproductive potential if they have a documented follicle stimulating hormone (FSH) value in the postmenopausal range.
  • A WOCBP who agrees to follow contraceptive guidance from the date of informed consent and for at least 150 days after the last dose of study treatment.
  • A male subject must agree to use contraception from the date of informed consent and for at least 120 days after the last dose of study treatment AND must refrain from donating sperm during this period.
  • Has measurable disease per RECIST Version 1.1, defined as at least one lesion that can be accurately measured by CT scan or MRI. Minimum measurement must be ≥10 mm as assessed by the Investigator. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
  • Has adequate organ function, as defined in table below. Specimens must be collected within 3 days prior to the start of study treatment.
  • System Laboratory Value Hematological
  • Absolute neutrophil count (ANC) ≥1500/µL or ≥1500/mm3
  • Platelets ≥100 000/µL or ≥100 000/mm3 Hemoglobin ≥90.0 g/L or ≥5.6 mmol/L1 Renal
  • Creatinine OR
  • Measured or calculated2 creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 ×ULN OR ≥60 mL/min for subject with creatinine levels >1.5 × institutional ULN
  • Hepatic
  • Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for subjects with total bilirubin levels >1.5 × ULN
  • AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for subjects with liver metastases)
  • Coagulation
  • International normalized ratio (INR) OR prothrombin time (PT)
  • Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless subject is receiving anticoagulant therapy provided PT or aPTT is within therapeutic range of intended use of anticoagulants
  • ALT (SGPT) = alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT) = aspartate aminotransferase (serum glutamic oxaloacetic transaminase);
  • GFR = glomerular filtration rate; ULN = upper limit of normal.
  • Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks.
  • Creatinine clearance (CrCl) will be calculated using the Cockcroft-Gault equation.
  • Capable of understanding and complying with protocol requirements.

Who cannot join

  • Subjects will be excluded if they fulfill any of the following exclusion criteria:
  • Pregnancy Exclusion
  • A WOCBP who has a positive urine pregnancy test (e.g. within 72 hours) prior to treatment. If the urine test is positive or cannot be confirmed as negative, a negative serum pregnancy test will be required.
  • Is breastfeeding or expecting to conceive or father children within the projected duration of the study, from the day date of informed consent through to 150 days after the last dose of study treatment for females, and 120 days after the last dose of study treatment for males.
  • Prior/Concomitant Therapy
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137) and was discontinued from that treatment due to a Grade 3 or higher immune-related adverse event (irAE).
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  • Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks or 5 half-lives, whichever is shorter, prior to treatment.
  • Note: Subjects must have recovered from all AEs due to previous therapies to ≤Grade 1 severity or baseline. Subjects with ≤Grade 2 neuropathy may be eligible at Investigator's discretion. Subjects with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible.
  • Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the surgery prior to starting study treatment, as determined by the Investigator.
  • Has received prior radiotherapy within 2 weeks of start of study treatment or have had a history of radiation pneumonitis. Note: Subjects must have recovered from all radiation-related toxicities, and not require corticosteroids. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease.
  • Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
  • Prior/Concurrent Clinical Study Experience
  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
  • Note: Subjects who have entered the follow-up phase of an investigational study may participate provided it has been 4 weeks after the last dose of the previous investigational agent.
  • Diagnostic Assessments
  • Average Fridericia-corrected QT interval (QTcF) >460 msec for males and QTcF >480 msec for females as measured by electrocardiogram (ECG) at Screening.
  • A family history of congenital long QT syndrome, Brugada syndrome or unexplained sudden cardiac death.
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug.
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
  • Note: Subjects with basal cell carcinoma of the skin, SCC of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded.
  • Has known active CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
  • Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients.
  • Has severe hypersensitivity (≥ Grade 3) to ENB-003 and/or any of its excipients
  • Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
  • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
  • Has an active infection requiring systemic therapy.
  • Subjects with known human immunodeficiency virus (HIV), active HBV or active HCV infections. Subjects who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to starting treatment (Note: Subjects should remain on HBV antiviral therapy throughout the study and follow local guidelines for HBV anti-viral therapy post completion of the study intervention).
  • Subjects with a history of HCV infection are eligible if HCV viral load is undetectable at screening (Note: must have completed curative anti-viral therapy at least 4 weeks prior to starting treatment).
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate, in the opinion of the treating Investigator.
  • Has a known psychiatric or substance abuse disorder that would interfere with the subject's ability to cooperate with the requirements of the study.
  • History of myocardial infarction ≤ 6 months prior to Screening, or uncontrolled congestive heart failure or uncontrolled atrial fibrillation or uncontrolled ventricular arrythmia.
  • Has a history of Pulmonary Arterial Hypertension or Renovascular Hypertension
  • Blood pressure ≥ (greater than or equal to)150/90 mm Hg.
  • Other Exclusions
  • Has had an allogenic tissue/solid organ transplant.
  • Has previously participated in this protocol [ENB-003-101 (MK3475-951)] i.e. a subject previously enrolled in Part A cannot participate in Part B.

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

Australia3 sites

  • Border Medical Oncology

    Albury, New South Wales, 2640

  • Blacktown Oncology

    Blacktown, New South Wales, 2148

  • Kinghorn-St Vincent's Hospital

    Darlinghurst, New South Wales, 2010

Other trials in Australia

United States2 sites

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Cedars Sinai-The Angeles Clinic

    Los Angeles, California, 90025

Other trials in United States

About this study

Official title: A Phase 1/2A Trial of ENB 003 in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors

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.

Read the detailed description

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.

Being tested
ENB003, Pembrolizumab
Keywords
solid tumors
Medical subject headings
Neoplasms, Melanoma, Ovarian Neoplasms, Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ENB003Drug

    ENB003 is selective Endothelin B Receptor Antagonist

  • PembrolizumabDrug

    Also called KEYTRUDA®, MK-3475

    anti-PD1

Study groups in NCT04205227
Study groupRoleWhat they receive
ENB003 150 ug + PembrolizumabExperimental150 ug ENB003 will be administered in combination with a fixed dose of pembrolizumab (200mg)
Receives: Drug: ENB003; Drug: Pembrolizumab
ENB003 300 ug + PembrolizumabExperimental300 ug ENB003 will be administered in combination with a fixed dose of pembrolizumab (200mg)
Receives: Drug: ENB003; Drug: Pembrolizumab
ENB003 500 ug + PembrolizumabExperimental500 ug ENB003 will be administered in combination with a fixed dose of pembrolizumab (200mg)
Receives: Drug: ENB003; Drug: Pembrolizumab
ENB003 750 ug + PembrolizumabExperimental750 ug ENB003 will be administered in combination with a fixed dose of pembrolizumab (200mg)
Receives: Drug: ENB003; Drug: Pembrolizumab
ENB003 1000 ug + PembrolizumabExperimental1000 ug ENB003 will be administered in combination with a fixed dose of pembrolizumab (200mg)
Receives: Drug: ENB003; Drug: Pembrolizumab
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
Receives: Drug: ENB003; Drug: Pembrolizumab
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)
Receives: Drug: ENB003; Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Incidence of Treatment-Emergent Adverse Events of ENB003 in combination with pembrolizumab, as assessed by NCI CTCAE Version 5

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

    Measured: assessed on every visit while subjects are in the study up to 2 years

  2. Part B: Efficacy of ENB003 in combination with pembrolizumab

    Melanoma and Ovarian Cancer:

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

    Measured: up to 2 years while subjects remain in the study

  3. Part B: Efficacy of ENB003 in combination with pembrolizumab

    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

    Measured: up to 2 years while subjects remain in the study

Secondary outcomes (12)

  1. Part B Efficacy Progression-free survival (PFS),

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

    Measured: up to 2 years

  2. Part B Efficacy: Duration of response

    based on RECIST

    Measured: up to 2 years

  3. Part B Efficacy: Time to progression

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

    Measured: up to 2 years

  4. Part B Efficacy: Overall survival

    defined as time from first dosing to date of death

    Measured: up to 2 years

  5. pharmacokinetic (PK) of ENB-003-AUC

    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

    Measured: at 05,10,15, 20, 30 45, 60 and 90 minutes, 2 hours, 3 hours, 5 hours, and 8 hours after administration of the ENB003, on Days -7 and -5 during dose escalation and days 1 and 5 during dose expansion

  6. pharmacokinetic (PK) of ENB-003-Cmax

    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

    Measured: at 05,10,15, 20, 30 45, 60 and 90 minutes, 2 hours, 3 hours, 5 hours, and 8 hours after administration of the ENB003, on Days -7 and -5 during dose escalation and days 1 and 5 during dose expansion

  7. pharmacokinetic (PK) of ENB-003-Tmax

    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

    Measured: at 05,10,15, 20, 30 45, 60 and 90 minutes, 2 hours, 3 hours, 5 hours, and 8 hours after administration of the ENB003, on Days -7 and -5 during dose escalation and days 1 and 5 during dose expansion

  8. pharmacokinetic (PK) of ENB-003-T1/2

    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

    Measured: at 05,10,15, 20, 30 45, 60 and 90 minutes, 2 hours, 3 hours, 5 hours, and 8 hours after administration of the ENB003, on Days -7 and -5 during dose escalation and days 1 and 5 during dose expansion

  9. pharmacokinetic (PK) of ENB-003-Vss

    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

    Measured: at 05,10,15, 20, 30 45, 60 and 90 minutes, 2 hours, 3 hours, 5 hours, and 8 hours after administration of the ENB003, on Days -7 and -5 during dose escalation and days 1 and 5 during dose expansion

  10. pharmacokinetic (PK) of ENB-003-CL

    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

    Measured: at 05,10,15, 20, 30 45, 60 and 90 minutes, 2 hours, 3 hours, 5 hours, and 8 hours after administration of the ENB003, on Days -7 and -5 during dose escalation and days 1 and 5 during dose expansion

  11. Exploratory: IHC assessment of ETBR

    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).

    Measured: single sample taken between day 5-8

  12. Exploratory: IHC assessment of PD-L1

    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).

    Measured: single sample taken between day 5-8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2019
  2. Study start18 Feb 2020
  3. Primary completion1 Jan 2026 (estimated)
  4. Study completion31 Mar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Model description
3+3 Dose Escalation and Open Label Expansion
Masking
None (open label)
Enrolment
137 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04205227
Sponsor's protocol ID
ENB-003-101 (MK3475-951)
Status last verified
Sep 2024
First submitted
12 Dec 2019
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ENB003 and Pembrolizumab in people with Cancer and Melanoma, run by ENB Therapeutics, Inc at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 62 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Australia, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Incidence of Treatment-Emergent Adverse Events of ENB003 in combination with pembrolizumab, as assessed by NCI CTCAE Version 5 (time frame: assessed on every visit while subjects are in the study up to 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04205227.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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