Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors

Incyte

Status and phase: Terminated; Phase 1

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

Treatments: Drug: INCB099318

Study type: Interventional

Funder types: Industry

Identifiers

NCT04272034

INCB 99318-122

2019-004990-21 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 3 patient groups

Cohort 1

Experimental group

Description:

Participants with select solid tumors who are immunotherapy treatment-naive

Treatment:

Drug: INCB099318

Cohort 2

Experimental group

Description:

Participants with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR) tumors who are immunotherapy treatment-naïve.

Treatment:

Drug: INCB099318

Cohort 3

Experimental group

Description:

Participants with progression of any solid tumor treated with an approved anti-PD-1 monoclonal antibody therapy

Treatment:

Drug: INCB099318