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

Purpose

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.

Conditions

  • Advanced Malignancies
  • Metastatic Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Phase 1: 20.0 Milligram Per Kilograms (mg/kg) Every 2 Weeks (Q2W) 		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.
  • Drug: INCAGN01876
    Initial cohort dose of INCAGN01876 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.
Experimental
Phase 1: 0.03 mg/kg Q2W 		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.
  • Drug: INCAGN01876
    Initial cohort dose of INCAGN01876 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.
Experimental
Phase 1: 0.1 mg/kg Q2W 		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.
  • Drug: INCAGN01876
    Initial cohort dose of INCAGN01876 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.
Experimental
Phase 1: 0.3 mg/kg Q2W 		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.
  • Drug: INCAGN01876
    Initial cohort dose of INCAGN01876 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.
Experimental
Phase 1: 1.0 mg/kg Q2W 		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.
  • Drug: INCAGN01876
    Initial cohort dose of INCAGN01876 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.
Experimental
Phase 1: 3.0 mg/kg Q2W 		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.
  • Drug: INCAGN01876
    Initial cohort dose of INCAGN01876 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.
Experimental
Phase 1: 5.0 mg/kg Q2W 		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.
  • Drug: INCAGN01876
    Initial cohort dose of INCAGN01876 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.
Experimental
Phase 1: 10.0 mg/kg Q2W 		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.
  • Drug: INCAGN01876
    Initial cohort dose of INCAGN01876 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.
Experimental
Phase 1: 400 mg/kg Every 4 Weeks (Q4W) 		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.
  • Drug: INCAGN01876
    Initial cohort dose of INCAGN01876 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.
Experimental
Phase 2: 300 mg/kg Q2W 		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.
  • Drug: INCAGN01876
    Initial cohort dose of INCAGN01876 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.

More Details

Status
Completed
Sponsor
Incyte Biosciences International Sàrl

Study Contact

For general questions about clinical trials, contact Research Support Services at (615) 322-7343 or research.support.services@vumc.org