A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Select Advanced Solid Tumors

INTRODUCTION

  • Org Study ID: INCB 99318-122
  • Secondary ID: N/A
  • NTC ID: NCT04272034
  • Sponsor: Incyte Corporation

BRIEF SUMMARY

The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of INCB099318 in select solid tumors.

  • Overall Status
    Recruiting
  • Start Date
    March 26, 2021
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Number of treatment-emergent adverse events

Primary Outcome 1 - Timeframe: Up to approximatley 25 months

CONDITION

  • Advanced Solid Tumors
  • MSI-H/dMMR Tumors
  • Cutaneous Squamous Cell Carcinoma
  • Urothelial Carcinoma
  • HCC
  • Cervical Cancer
  • Esophageal Squamous Cell Carcinoma
  • Merkel Cell Carcinoma
  • Small-cell Lung Cancer
  • Mesothelioma
  • PD-L1 Amplified Tumor (9p24.1)
  • Nasopharyngeal Carcinoma
  • Cyclin-dependent Kinase 12 Mutated Tumors
  • Basal Cell Carcinoma (Unresectable or Metastatic)
  • Sarcomatoid Renal Cell Carcinoma
  • Clear Cell Ovarian or Endometrial Carcinoma
  • Anal Carcinoma
  • Squamous Cell Penile Carcinoma
  • DNA Polymerase Epsilon Mutated Tumors (P286R and V411L)

ELIGIBILITY

Inclusion Criteria:
Must have disease progression after treatment with available therapies that are known to confer clinical benefit or must be intolerant to or ineligible for standard treatment.

- Histologically confirmed advanced solid tumors (protocol-defined select solid tumors) with measurable lesions per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) that are considered nonamenable to surgery or other curative treatments or procedures.

- ECOG performance status score of 0 or 1.

- Life expectancy > 12 weeks.

- Willingness to avoid pregnancy or fathering children.
Exclusion Criteria:
Exclusion Criteria:
Laboratory values outside the Protocol-defined ranges.

- Clinically significant cardiac disease.

- History or presence of an ECG that, in the investigator's opinion, is clinically meaningful.

- Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases that have progressed (eg, evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain or CNS metastases).

- Known additional malignancy that is progressing or requires active treatment.

- Has not recovered to ≤ Grade 1 or baseline from toxic effects of prior therapy (including prior IO) and/or complications from prior surgical intervention before starting study treatment.

- Prior receipt of an anti-PD-L1 therapy.

- Treatment with anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.

- A 28-day washout for systemic antibiotics is required.

- Probiotic usage while on study and during screening is prohibited.

- Active infection requiring systemic therapy.

- Known history of HIV

- Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Louis Viviers, MD

Role: Study Director

Affiliation: Incyte Corporation

Overall Contact

Name: Louis Viviers, MD

Phone: 1.855.463.3463, +800 00027423

Email: medinfo@incyte.com, globalmedinfo@incyte.com

LOCATION

Facility Status Contact
Facility: Hackensack University Medical Center
Hackensack, New Jersey 07601
United States
Status: Recruiting Contact: N/A
Facility: Prisma Health Cancer Institute Faris
Greenville, South Carolina 29605
United States
Status: Recruiting Contact: N/A
Facility: The Royal Marsden Hospital Nhs Trust London
London, SM2 5PT
United Kingdom
Status: Recruiting Contact: N/A