Neoplasms

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Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

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Carcinoma, Non-Small-Cell Lung

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Antibodies

Antibodies, Monoclonal

Immunoglobulins

Immunoglobulin G

Immunoglobulins, Intravenous

Initial cohort dose of INCAGN01949 monotherapy at the protocol-defined starting dose, with subsequent cohort escalations based on protocol-specific criteria. The recommended dose will be taken forward into expansion cohorts.

INCAGN01949

John E. Janik, MD

The purpose of this study is to determine the safety and tolerability and assess preliminary efficacy of INCAGN01949 in subjects with advanced or metastatic solid tumors.

A Phase 1/2, Open-Label, Dose-Escalation, Safety Study of INCAGN01949 in Subjects With Advanced or Metastatic Solid Tumors

A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN01949 in Subjects With Advanced or Metastatic Solid Tumors

Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment

To evaluate the Cmax of INCAGN01949 in subjects with advanced or metastatic solid tumors.

To evaluate the AUC0-t of INCAGN01949 in subjects with advanced or metastatic solid tumors

ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.

To evaluate the Tmax of INCAGN01949 in subjects with advanced or metastatic solid tumors.

To evaluate the Cmin of INCAGN01949 in subjects with advanced or metastatic solid tumors. Cmin is the minimum observed concentration of INCAGN1949

Incyte Biosciences International Sàrl

INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors

PART 1 Dose 1 (7 mg)

INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors

PART 1 Dose 2 (20 mg)

INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors

PART 1 Dose 3 (70 mg)

INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors

PART 1 Dose 4 (200 mg)

INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors

PART 1 Dose 5 (350 mg)

INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors

PART 1 Dose 6 (700 mg)

INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors

PART 1 Dose 7 (1400 mg)

Total

Age, Continuous

Sex: Female, Male

White/Caucasian

Asian

Other

Black/African American

Race/Ethnicity, Customized

Hispanic or Latino

Not Hispanic or Latino

Not Reported

The PK evaluable population will include all subjects who received at least 1 dose of INCAGN01949 and provided at least 1 post dose sample (1 PK measurement).

Maximum Observed Concentration (Cmax) of INCAGN01949 in Plasma

cycle 1

cycle 6

Area Under the Single-dose Concentration-time Curve (AUC0-t) of INCAGN01949

The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCAGN01949.

Objective Response Rate Per RECIST and Modified RECIST

The Full Analysis Set population included all subjects enrolled in the study who received at least 1 dose of INCAGN01949. Median was not estimable due to insufficient number of participants with response

Duration of Response Per RECIST and Modified RECIST

Progression-free Survival Per RECIST and Modified RECIST

The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCAGN01949. Median was not estimable due to insufficient number of participants with CR, PR, and SD

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Phase 1/2, Open-Label, Dose-Escalation, Safety Study of INCAGN01949 in Subjects With Advanced or Metastatic Solid Tumors	NCT02923349	Advanced Malign... Metastatic Canc...	INCAGN01949	18 Years -	Incyte Corporation
A Phase 1/2, Open-Label, Dose-Escalation, Safety Study of INCAGN01949 in Subjects With Advanced or Metastatic Solid Tumors	NCT02923349	Advanced Malign... Metastatic Canc...	INCAGN01949	18 Years -	Incyte Corporation

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