MK-1088 for Solid Tumors, Advanced Solid Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0201), Toronto, Canada
Solid Tumors, Advanced Solid Tumors+1 More
MK-1088 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The study will evaluate the safety, tolerability, and pharmacokinetics (PK) of MK-1088 in monotherapy and in combination with pembrolizumab in participants with advanced solid tumors who have not responded to conventional therapy. The effect of MK-1088 on tumor size will also be examined.

Eligible Conditions

  • Solid Tumors, Advanced Solid Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Solid Tumors, Advanced Solid Tumors

Study Objectives

3 Primary · 4 Secondary · Reporting Duration: Up to ~3 years

Month 27
Area under the plasma concentration-time curve (AUC) of MK-1088
Maximum plasma concentration (Cmax) of MK-1088
Up to 21 days
Number of participants experiencing a dose-limiting toxicity (DLT)
Up to ~24 months
Number of participants discontinuing study treatment due to an AE
Up to ~27 months
Number of participants experiencing an adverse event (AE)
Up to ~3 years
ORR per Prostate Cancer Working Group (PCWG)-modified RECIST 1.1 as assessed by investigator
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) as assessed by investigator

Trial Safety

Safety Progress

1 of 3

Other trials for Solid Tumors, Advanced Solid Tumors

Trial Design

2 Treatment Groups

MK-1088
1 of 2
MK-1088 + Pembrolizumab
1 of 2
Experimental Treatment

80 Total Participants · 2 Treatment Groups

Primary Treatment: MK-1088 · No Placebo Group · Phase 1 & 2

MK-1088
Drug
Experimental Group · 1 Intervention: MK-1088 · Intervention Types: Drug
MK-1088 + PembrolizumabExperimental Group · 2 Interventions: MK-1088, Pembrolizumab · Intervention Types: Drug, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2670

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to ~3 years
Closest Location: Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0201) · Toronto, Canada
Photo of Toronto 1Photo of Toronto 2Photo of Toronto 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Solid Tumors, Advanced Solid Tumors
0 CompletedClinical Trials

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,626 Previous Clinical Trials
4,948,348 Total Patients Enrolled
30 Trials studying Solid Tumors, Advanced Solid Tumors
8,823 Patients Enrolled for Solid Tumors, Advanced Solid Tumors
Medical DirectorStudy DirectorMerck Sharpe & Dohme LLC
2,597 Previous Clinical Trials
8,931,265 Total Patients Enrolled
20 Trials studying Solid Tumors, Advanced Solid Tumors
3,948 Patients Enrolled for Solid Tumors, Advanced Solid Tumors

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.