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Arginase Inhibitor

INCB00158 was administered as monotherapy at 75mg twice daily for Mesothelioma

Phase 1 & 2
Waitlist Available
Research Sponsored by Incyte Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until disease progression/study discontinuation up to 24 months
Awards & highlights

Study Summary

This study is evaluating whether INCB001158 is safe and has activity in people with advanced/metastatic solid tumors.

Eligible Conditions
  • Mesothelioma
  • Cancer
  • Solid Tumors
  • Colorectal Cancer
  • Stomach Cancer
  • Head and Neck Cancers
  • Lung Cancer
  • Kidney Cancer
  • Bladder Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until disease progression/study discontinuation up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and until disease progression/study discontinuation up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determination of the Safety and Tolerability of INCB001158 as a Single Agent and in Combination With Pembrolizumab: Incidence of Adverse Events
Secondary outcome measures
AUC0-12 Plasma Pharmacokinetic (PK) Profile of INCB001158
AUCt Plasma Pharmacokinetic (PK) Profile of INCB001158
Combined Modality Therapy
+8 more

Trial Design

8Treatment groups
Experimental Treatment
Group I: INCB00158 was administered in combination with pembroluzimab at 75mg twice dailyExperimental Treatment2 Interventions
Combination Part 1b: INCB001158 and Pembrolizumab administered in patients with advanced/metastatic NSCLC, Melanoma, Urothelial Cell Cancer, MSI CRC, MSS CRC, Gastric or Gastroesophageal Junction (GEJ) Cancer, SCCHN and Mesothelioma. Multiple dose levels will be explored to determine the recommended phase 2 dose (RP2D).
Group II: INCB00158 was administered in combination with pembroluzimab at 50mg twice dailyExperimental Treatment1 Intervention
Monotherapy Part 2d: INCB001158 administered orally at the RP2D in patients with any tumor types in Parts 2a, 2b, or 2c.
Group III: INCB00158 was administered in combination with pembroluzimab at 100mg twice dailyExperimental Treatment2 Interventions
Part 3a: INCB001158 and Pembrolizumab the combination RP2D in patients with advanced/metastatic NSCLC (EGFR and ALK negative) with disease progression on anti-PD-1 therapy or prolonged stable disease on Pembrolizumab in the immediate prior line of therapy.
Group IV: INCB00158 was administered as monotherapy at 75mg twice dailyExperimental Treatment1 Intervention
Monotherapy Part 2a: INCB001158 administered orally at the RP2D in patients with advanced/metastatic NSCLC (EGFR and Anaplastic Lymphoma Kinase (ALK) negative) previously treated with Standard of Care (SOC).
Group V: INCB00158 was administered as monotherapy at 50mg twice dailyExperimental Treatment1 Intervention
Monotherapy Part 1a: INCB001158 administered orally in patients with advanced/metastatic solid tumors. Escalating doses will be explored to determine the recommended phase 2 dose (RP2D).
Group VI: INCB00158 was administered as monotherapy at 150mg twice dailyExperimental Treatment1 Intervention
Monotherapy Part 2c: INCB001158 administered orally at the RP2D in patients with Bladder Cancer, Gastric or Gastroesophageal Junction (GEJ) Cancer, Renal Cell Cancer (RCC), Squamous Cell Carcinoma of the Head and Neck (SCCHN), Urothelial Cell Cancer (UCC), or Melanoma, previously treated with SOC.
Group VII: INCB00158 was administered as monotherapy at 100mg twice dailyExperimental Treatment1 Intervention
Monotherapy Part 2b: INCB001158 administered orally at the RP2D in patients with advanced/metastatic CRC previously treated with SOC.
Group VIII: INCB001158 50 mg BID in combination with pembrolizumabExperimental Treatment2 Interventions
Part C: evaluated a reduced dose of INCB001158 50 mg BID in combination with pembrolizumab with patients with moderately impaired renal function.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
INCB001158
2019
Completed Phase 2
~430
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
364 Previous Clinical Trials
54,905 Total Patients Enrolled
4 Trials studying Mesothelioma
348 Patients Enrolled for Mesothelioma
Emil Kuriakose, MDStudy DirectorCalithera Biosciences, Inc
3 Previous Clinical Trials
113 Total Patients Enrolled
Sven Gogov, MDStudy DirectorIncyte Corporation
5 Previous Clinical Trials
318 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Arginase Inhibitor INCB001158 as a Single Agent and in Combination With Immune Checkpoint Therapy in Patients With Advanced/Metastatic Solid Tumors
2016. "Arginase Inhibitor INCB001158 as a Single Agent and in Combination With Immune Checkpoint Therapy in Patients With Advanced/Metastatic Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02903914.
~30 spots leftby Apr 2025
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