INCAGN01876 for Metastatic Cancers

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Dana Farber Cancer Institute, Boston, MA
Metastatic Cancers+7 More
INCAGN01876 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this study is to determine the safety, tolerability, efficacy, PK and pharmacodynamics of INCAGN01876 when given in combination with retifanlimab. The study will consist of 2 parts: a safety lead-in part (Part 1) followed by a dose expansion part (Part 2).

Eligible Conditions

  • Metastatic Cancers
  • Advanced Malignancies
  • Recurrent Cancer
  • Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Metastatic Cancers

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Screening through 90 days after end of treatment, up to 24 months

Month 24
Disease control rate (DCR) based on RECIST v1.1 and mRECIST
Duration of response (DOR) based on RECIST v1.1 and mRECIST
Progression-free survival (PFS) based on RECIST v1.1 and mRECIST
Month 24
Objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Month 24
Part 1: Participants With Treatment-Emergent Adverse Events (TEAEs)
Part 2: Participants With Treatment-Emergent Adverse Events (TEAEs)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Metastatic Cancers

Trial Design

4 Treatment Groups

Part 1: Cohort 1
1 of 4
Part 1: Cohort 2
1 of 4
Part 2 (Expansion): Treatment Group B
1 of 4
Part 2 (Expansion): Treatment Group A
1 of 4
Experimental Treatment

47 Total Participants · 4 Treatment Groups

Primary Treatment: INCAGN01876 · No Placebo Group · Phase 2

Part 1: Cohort 1Experimental Group · 2 Interventions: retifanlimab, INCAGN01876 · Intervention Types: Biological, Biological
Part 1: Cohort 2Experimental Group · 2 Interventions: retifanlimab, INCAGN01876 · Intervention Types: Biological, Biological
Part 2 (Expansion): Treatment Group BExperimental Group · 2 Interventions: retifanlimab, INCAGN01876 · Intervention Types: Biological, Biological
Part 2 (Expansion): Treatment Group AExperimental Group · 2 Interventions: retifanlimab, INCAGN01876 · Intervention Types: Biological, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
retifanlimab
2018
Completed Phase 1
~30
INCAGN01876
2016
Completed Phase 2
~250

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: screening through 90 days after end of treatment, up to 24 months
Closest Location: Dana Farber Cancer Institute · Boston, MA
Photo of dana farber cancer institute  1Photo of dana farber cancer institute  2Photo of dana farber cancer institute  3
2004First Recorded Clinical Trial
9 TrialsResearching Metastatic Cancers
539 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a tumor that is GITR-positive.

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.