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Pembrolizumab for Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Cancer+4 MorePembrolizumab - Drug
Eligibility
18 - 80
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Solid Tumors
  • Cancer
  • Ovarian Cancer
  • Melanoma
  • Pancreatic Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
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1
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1
TJ033721

Study Objectives

2 Primary · 8 Secondary · Reporting Duration: up to 2 years while subjects remain in the study

Year 2
Incidence of Treatment-Emergent Adverse Events of ENB003 in combination with pembrolizumab, as assessed by NCI CTCAE Version 5
Day 1
pharmacokinetic (PK) of ENB-003-AUC
pharmacokinetic (PK) of ENB-003-CL
pharmacokinetic (PK) of ENB-003-Cmax
pharmacokinetic (PK) of ENB-003-T1/2
pharmacokinetic (PK) of ENB-003-Tmax
pharmacokinetic (PK) of ENB-003-Vss
Day 5
Exploratory: IHC assessment of ETBR
Exploratory: IHC assessment of PD-L1
Year 2
Efficacy of ENB003 in combination with pembrolizumab measured by tumor ORR

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Pembrolizumab
1
Dose Escalation (Phase 1)
1
TJ033721

Side Effects for

Pembrolizumab Second Course
100%Parkinsonism
100%Urinary tract infection
100%Inappropriate antidiuretic hormone secretion
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab Second Course ARM group. Side effects include: Parkinsonism with 100%, Urinary tract infection with 100%, Inappropriate antidiuretic hormone secretion with 100%.

Trial Design

6 Treatment Groups

ENB003 500 ug + Pembrolizumab
1 of 6
ENB003 750 ug + Pembrolizumab
1 of 6
ENB003 RP2D from dose eascalation + Pembrolizumab
1 of 6
ENB003 150 ug + Pembrolizumab
1 of 6
ENB003 300 ug + Pembrolizumab
1 of 6
ENB003 1000 ug + Pembrolizumab
1 of 6

Experimental Treatment

130 Total Participants · 6 Treatment Groups

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 1 & 2

ENB003 500 ug + PembrolizumabExperimental Group · 2 Interventions: ENB003, Pembrolizumab · Intervention Types: Drug, Drug
ENB003 750 ug + PembrolizumabExperimental Group · 2 Interventions: ENB003, Pembrolizumab · Intervention Types: Drug, Drug
ENB003 RP2D from dose eascalation + PembrolizumabExperimental Group · 2 Interventions: ENB003, Pembrolizumab · Intervention Types: Drug, Drug
ENB003 150 ug + PembrolizumabExperimental Group · 2 Interventions: ENB003, Pembrolizumab · Intervention Types: Drug, Drug
ENB003 300 ug + PembrolizumabExperimental Group · 2 Interventions: ENB003, Pembrolizumab · Intervention Types: Drug, Drug
ENB003 1000 ug + PembrolizumabExperimental Group · 2 Interventions: ENB003, Pembrolizumab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years while subjects remain in the study

Who is running the clinical trial?

ENB Therapeutics, IncLead Sponsor
Merck Sharp & Dohme LLCIndustry Sponsor
3,684 Previous Clinical Trials
4,957,998 Total Patients Enrolled

Eligibility Criteria

Age 18 - 80 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have advanced, unresectable or metastatic melanoma.
You have demonstrated disease progression (PD) after PD-1/L1 as defined by RECIST Version 1.1.
Subjects with MSI-H or dMMR phenotype must have been previously treated with anti-PD1 and demonstrated either PD or disease stabilization.
You have received at least 2 doses of an approved anti-PD-1/L1 mAb.
You have progressive disease within 12 weeks from the last dose of anti-PD-1/L1 mAb.1.
The date of PD documentation is considered the date of PD.
You have pancreatic cancer.
Subjects with one or more prior treatments for their pancreatic cancer.
References

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