ADG126 for Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
HonorHealth Research Institute, Scottsdale, AZ
Cancer+1 More
ADG126 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a Phase 1b/2, open-label, dose escalation study to evaluate the safety, tolerability, PK, and immunogenicity of an ADG126-pembrolizumab combination regimen in patients with advanced/metastatic solid tumors.

Eligible Conditions

  • Cancer
  • Advanced/Metastatic Solid Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 8 Secondary · Reporting Duration: 9 months

9 months
Dose-limiting toxicity (DLT) and RP2D for ADG126 in combination with pembrolizumab.
recommended Phase 2 dose (RP2D) of ADG126 in combination with pembrolizumab
the maximum tolerated dose (MTD) for ADG126 in combination with pembrolizumab.
the safety and tolerability of ADG126 in combination with pembrolizumab
Year 2
Incidence of ADAs
Maximum (peak) plasma concentration (Cmax)
Pharmacokinetic (PK) profile/parameters
Time to maximum (peak) concentration (Tmax)
To assess the disease control rate (DCR)
To assess the overall survival (OS)
To assess the progression free survival (PFS)
Trough concentration (Ctrough)

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

ADG126 in combination with Pembrolizumab
1 of 1
Experimental Treatment

102 Total Participants · 1 Treatment Group

Primary Treatment: ADG126 · No Placebo Group · Phase 1

ADG126 in combination with Pembrolizumab
Drug
Experimental Group · 1 Intervention: ADG126 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 9 months
Closest Location: HonorHealth Research Institute · Scottsdale, AZ
Photo of Scottsdale 1Photo of Scottsdale 2Photo of Scottsdale 3
2017First Recorded Clinical Trial
0 TrialsResearching Cancer
32 CompletedClinical Trials

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,626 Previous Clinical Trials
4,948,326 Total Patients Enrolled
Adagene IncLead Sponsor
8 Previous Clinical Trials
582 Total Patients Enrolled
Jiping zha, MDStudy ChairAdagene Inc

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Patients with serum bilirubin increases due to documented underlying Gilbert's Syndrome or familial benign unconjugated hyperbilirubinemia may be enrolled.
You have advanced or metastatic solid tumors, histologically or pathologically confirmed, who have progressed after all standard therapies, or for whom no further standard therapy exists.
Patients should have at least 1 measurable lesion at baseline according to the definition of RECIST v1.1
ANC ≥ 1.5 ×109/L, without the use of granulocyte colony stimulating factor such as filgrastim within 2 weeks prior to study treatment.

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.