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Other

ENB003 + Pembrolizumab for Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by ENB Therapeutics, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pancreatic Cancer: Subjects must have previously received and progressed on FOLFIRINOX or a gemcitabine-based regimen for their pancreatic cancer
SCC of the Head and Neck: Subjects must have progressed on treatment with an anti-PD1/Ligand 1 (L1) monoclonal antibody (mAb)
Must not have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial is testing a new cancer drug, ENB003, to see if it is safe and effective. The study will first test the drug on a small group of people to see what doses are safe. Then the study will be expanded to include more people with different types of cancer.

Who is the study for?
This trial is for adults with certain solid tumors, including metastatic melanoma, platinum-resistant ovarian cancer, and pancreatic cancer. Participants must have tried some standard treatments without success and can't have had more than three prior systemic therapies. Pregnant women or those who've had severe reactions to similar drugs are excluded.
What is being tested?
The study tests ENB003 combined with Pembrolizumab on patients with solid tumors. It has two parts: Part A finds the safest dose (RP2D) through a '3+3' method; Part B expands the trial using this dose on specific cancers, including an exploratory group of sarcoma patients.
What are the potential side effects?
Possible side effects include immune-related issues due to both drugs being immunotherapies which may cause inflammation in various organs, infusion reactions related to the drug administration process, fatigue from treatment burden, digestive problems like nausea or diarrhea, blood disorders such as anemia or clotting issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My pancreatic cancer has worsened despite treatment with FOLFIRINOX or a gemcitabine-based regimen.
Select...
My head or neck cancer worsened despite treatment with an anti-PD1/L1 drug.
Select...
My breast cancer is triple negative and has spread.
Select...
My melanoma cannot be removed by surgery and has spread.
Select...
My breast cancer is triple negative and has been tested for PD-L1.
Select...
My pancreatic cancer is advanced, cannot be surgically removed, or has come back after surgery.
Select...
My cancer is a type of skin cancer that has spread from my head or neck.
Select...
My ovarian cancer did not respond to initial platinum-based chemotherapy.
Select...
I have a confirmed diagnosis of advanced ovarian, fallopian tube, or peritoneal cancer.
Select...
My melanoma got worse despite treatment with an anti-PD1/L1 drug.
Select...
I have had 3 or fewer treatments for advanced melanoma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I stopped a cancer immunotherapy due to a severe side effect.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part A: Incidence of Treatment-Emergent Adverse Events of ENB003 in combination with pembrolizumab, as assessed by NCI CTCAE Version 5
Part B: Efficacy of ENB003 in combination with pembrolizumab
Secondary study objectives
Exploratory: IHC assessment of ETBR
Exploratory: IHC assessment of PD-L1
Part B Efficacy Progression-free survival (PFS)
+9 more

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999
64%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Clostridium difficile colitis
1%
Systemic infection
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + CRT Followed by Placebo
Pembrolizumab + CRT Followed by Pembrolizumab

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

7Treatment groups
Experimental Treatment
Group I: ENB003 RP2D from dose escalation + PembrolizumabExperimental Treatment2 Interventions
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)
Group II: ENB003 750 ug + PembrolizumabExperimental Treatment2 Interventions
750 ug ENB003 will be administered in combination with a fixed dose of pembrolizumab (200mg)
Group III: ENB003 500 ug + PembrolizumabExperimental Treatment2 Interventions
500 ug ENB003 will be administered in combination with a fixed dose of pembrolizumab (200mg)
Group IV: ENB003 300 ug + PembrolizumabExperimental Treatment2 Interventions
300 ug ENB003 will be administered in combination with a fixed dose of pembrolizumab (200mg)
Group V: ENB003 2000 ug + PembrolizumabExperimental Treatment2 Interventions
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
Group VI: ENB003 150 ug + PembrolizumabExperimental Treatment2 Interventions
150 ug ENB003 will be administered in combination with a fixed dose of pembrolizumab (200mg)
Group VII: ENB003 1000 ug + PembrolizumabExperimental Treatment2 Interventions
1000 ug ENB003 will be administered in combination with a fixed dose of pembrolizumab (200mg)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Find a Location

Who is running the clinical trial?

ENB Therapeutics, IncLead Sponsor
Merck Sharp & Dohme LLCIndustry Sponsor
4,007 Previous Clinical Trials
5,184,963 Total Patients Enrolled

Media Library

ENB003 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04205227 — Phase 1 & 2
Cancer Research Study Groups: ENB003 150 ug + Pembrolizumab, ENB003 300 ug + Pembrolizumab, ENB003 500 ug + Pembrolizumab, ENB003 750 ug + Pembrolizumab, ENB003 1000 ug + Pembrolizumab, ENB003 2000 ug + Pembrolizumab, ENB003 RP2D from dose escalation + Pembrolizumab
Cancer Clinical Trial 2023: ENB003 Highlights & Side Effects. Trial Name: NCT04205227 — Phase 1 & 2
ENB003 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04205227 — Phase 1 & 2
~25 spots leftby Jan 2026
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