A Study of INCAGN01876 in Participants With Advanced or Metastatic Solid Tumors

Incyte

Status and phase: Completed; Phase 2; Phase 1

Conditions: Metastatic Cancer; Advanced Malignancies

Treatments: Drug: INCAGN01876

Study type: Interventional

Funder types: Industry

Identifiers

NCT02697591

INCAGN 1876-101

Details and patient eligibility

About

This was an open-label, non-randomized Phase 1/2 safety study of INCAGN01876 in participants with advanced or metastatic solid tumors that was conducted in 2 parts. Part 1 is dose escalation and safety expansion which determines the optimal dose and maximum number of tolerated doses. Part 2 is dose expansion in which Part 1 recommended dose will be evaluated.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent.
• Part 1: Participants with advanced or metastatic solid tumors.
• Part 2: Participants with advanced or metastatic adenocarcinoma of endometrium, melanoma, non-small cell lung cancer, and renal cell carcinoma.
• Participants who have disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment, or participants who refuse standard treatment.
• Presence of measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.

Exclusion criteria

• Laboratory and medical history parameters not within the protocol-defined range.
• Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
• Has not recovered to ≤ Grade 1 from toxic effects of prior therapy and/or complications from prior surgical intervention before starting therapy.
• Receipt of a live vaccine within 30 days of planned start of study therapy.
• Active autoimmune disease.
• Prior treatment with any tumor necrosis factor super family agonist.
• Known active central nervous system metastases and/or carcinomatous meningitis.
• Evidence of active, non-infectious pneumonitis or history of interstitial lung disease.
• Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 10 patient groups

Phase 1: 20.0 Milligram Per Kilograms (mg/kg) Every 2 Weeks (Q2W)

Experimental group

Description:

Participants received IV infusion of study drug at a dose of 20.0 mg/kg every Q2W starting on Day 1 of each cycle for up to 15 months.

Treatment:

Drug: INCAGN01876

Phase 1: 0.03 mg/kg Q2W

Experimental group

Description:

Participants received intravenous (IV) infusion of study drug at a dose of 0.03 mg/kg every Q2W starting on Day 1 of each cycle for up to 15 months.

Treatment:

Drug: INCAGN01876

Phase 1: 0.1 mg/kg Q2W

Experimental group

Description:

Participants received IV infusion of study drug at a dose of 0.1 mg/kg every Q2W starting on Day 1 of each cycle for up to 15 months.

Treatment:

Drug: INCAGN01876

Phase 1: 0.3 mg/kg Q2W

Experimental group

Description:

Participants received IV infusion of study drug at a dose of 0.3 mg/kg every Q2W starting on Day 1 of each cycle for up to 15 months.

Treatment:

Drug: INCAGN01876

Phase 1: 1.0 mg/kg Q2W

Experimental group

Description:

Participants received IV infusion of study drug at a dose of 1.0 mg/kg every Q2W starting on Day 1 of each cycle for up to 15 months.

Treatment:

Drug: INCAGN01876

Phase 1: 3.0 mg/kg Q2W

Experimental group

Description:

Participants received IV infusion of study drug at a dose of 3.0 mg/kg every Q2W starting on Day 1 of each cycle for up to 15 months.

Treatment:

Drug: INCAGN01876

Phase 1: 5.0 mg/kg Q2W

Experimental group

Description:

Participants received IV infusion of study drug at a dose of 5.0 mg/kg every Q2W starting on Day 1 of each cycle for up to 15 months.

Treatment:

Drug: INCAGN01876

Phase 1: 10.0 mg/kg Q2W

Experimental group

Description:

Participants received IV infusion of study drug at a dose of 10.0 mg/kg every Q2W starting on Day 1 of each cycle for up to 15 months.

Treatment:

Drug: INCAGN01876

Phase 1: 400 mg/kg Every 4 Weeks (Q4W)

Experimental group

Description:

Participants received IV infusion of study drug at a dose of 400 mg/kg every Q2W starting on Day 1 of each cycle for up to 15 months.

Treatment:

Drug: INCAGN01876

Phase 2: 300 mg/kg Q2W

Experimental group

Description:

Participants received IV infusion of study drug at a dose of 300 mg/kg every Q2W starting on Day 1 of each cycle for up to 15 months.

Treatment:

Drug: INCAGN01876