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ENB003 + Pembrolizumab for Cancer

Q: What are the main indications for Pembrolizumab?

<p>Pembrolizumab is a medication used to treat <a href="https://www.withpower.com/clinical-trials/cancer">cancer</a>. Some of the malignant neoplasms it can be used for include unresectable <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a>, microsatellite instability high, and disease progression after chemotherapy.</p>

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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My head or neck cancer worsened despite treatment with an anti-PD1/L1 drug.

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My breast cancer is triple negative and has spread.

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My melanoma cannot be removed by surgery and has spread.

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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...

I have ovarian cancer and have had up to 3 treatments for it.

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My cancer is a type of skin cancer that has spread from my head or neck.

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My ovarian cancer did not respond to initial platinum-based chemotherapy.

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I have a confirmed diagnosis of advanced ovarian, fallopian tube, or peritoneal cancer.

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I have had at most 2 treatments for my advanced pancreatic cancer.

Select...

My melanoma got worse despite treatment with an anti-PD1/L1 drug.

Select...

My condition worsened after treatment, and I've had 3 or fewer prior treatments.

Select...

I have had 3 or fewer treatments for advanced melanoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

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

0 / 14Eligibility criteria met

Find a Location

Who is running the clinical trial?

ENB Therapeutics, IncLead Sponsor

Merck Sharp & Dohme LLCIndustry Sponsor

3,886 Previous Clinical Trials

5,054,434 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the main goals of this medical study?

"The primary efficacy outcome of this study will be measured by ORR, and time frame for evaluation is up to 2 years. Secondary outcomes include the pharmacokinetic parameters Cmax, AUC, and Tmax which will be measured through blood samples over an 8 hour period."

Answered by AI

Might I be a candidate for this clinical research?

"This clinical trial is recruiting 130 participants, between the ages of 18 and 80 who have malignancies. It is important that participants also meet the following criteria: -Histopathologically confirmed diagnosis of advanced, unresectable or metastatic malignant melanoma., -Has demonstrated disease progression (PD) after PD-1/L1 as defined by RECIST Version 1.1. The initial evidence of PD is to be confirmed by a second assessment no less than four weeks from the date of the first documented PD, in the absence of rapid clinical progression.1, -If subjects have high micro"

Answered by AI

Are people currently signing up to participate in this research?

"The study is currently recruiting patients, according to the clinicaltrials.gov website. The trial was originally posted on February 18th, 2020 and last updated March 4th, 2021."

Answered by AI

What are the most similar previous medical studies to this one involving Pembrolizumab?

"Pembrolizumab is being trialed in 1000 ongoing studies, 122 of which are in Phase 3. The global clinical trial landscape for Pembrolizumab is largely located in Houston, Texas; however, there are 36030 locations running trials for this medication."

Answered by AI

If an individual is over 18 years old, do they qualify to participate in this particular medical study?

"According to the information available, this trial is only open to applicants between 18-80 years old. Out of the 4,126 similar studies found, 206 were for patients under 18 and 3,526 were for people over 65."

Answered by AI

What are the main indications for Pembrolizumab?

"Pembrolizumab is a medication used to treat cancer. Some of the malignant neoplasms it can be used for include unresectable melanoma, microsatellite instability high, and disease progression after chemotherapy."

Answered by AI

What is the total sample size for this research project?

"That is correct. The clinical trial, which was originally posted on February 18th 2020 and updated on March 4th 2021, is still recruiting patients. They have 1 site and are looking for 130 individuals in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "ENB003 Plus Pembrolizumab Phase 1b/2a in Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04205227.

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