To Assess the Safety and Tolerability of Tafasitamab Alone or in Combination With Other Drugs in Japanese Participants With Non-Hodgkins Lymphoma (NHL)

Sponsor
Incyte Biosciences Japan GK
Study ID
NCT04661007
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • tafasitamab — DRUG
    tafasitamab will be administered at protocol defined timepoints based on the groups participants are assigned.
  • lenalidomide — DRUG
    lenalidomide will be administered orally at protocol defined timepoints based on the groups participants are assigned.
  • parsaclisib — DRUG
    parsaclisib will be administered at protocol defined timepoints based on the groups participants are assigned.
  • R-CHOP — DRUG
    R-CHOP is a combination regimen consisting of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone. R-CHOP will be administered at protocol defined timepoints based on the groups participants are assigned.

Study Details

This is an open-label, multicenter study to evaluate safety and tolerability, determine the RP2Ds of tafasitamab alone in Japanese participants with R/R NHL, or to evaluate efficacy and safety of tafasitamab in combination with lenalidomide in Japanese participants with R/R DLBCL, or tafasitimab in combination with lenalidomide plus R-CHOP in Japanese participants with previously untreated DLBC, or tafasitimab in combination with lenalidomide in Japanese participants with previously R/R DLBC.

Key Dates

First listed
Dec 9, 2020
Start date
Dec 15, 2020
Status verified
May 2026
Primary completion
Jul 1, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
72 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 : tafasitimab monotherapy
    Dose-finding to evaluate the safety and tolerability and to determine the RP2Ds of single-agent tafasitamab in Japanese participants with NHL. Part 1 consists of 1 group (Group 1) to evaluate weight-based doses of tafasitamab.
  • Experimental: Part 2 : tafasitamab combination therapy
    tafasitamab will be combined with lenalidomide (Group 3) or parsaclisib (Group 4a) in R/R DLBCL participants or lenalidomide plus R-CHOP (Group 5) in previously untreated DLBCL participants. Modified tafasitamab dosing when combined with lenalidomide (Group 2) in participants with R/R DLBCL will be evaluated to determine the recommended clinical dose. The dose of tafasitamab will be based on the weight-based RP2D that is deemed safe and tolerable in Part 1.
  • Experimental: Part 3 : Dose Expansion of tafasitamab +parsaclisib
    tafasitamab in combination with parsaclisib will be further evaluated in Group 4b at RP2D determined in Part 2
  • Experimental: Part 4: tafasitamab combination therapy
    tafasitamiab in combination with lenalidomide will be further evaluated in Group 6 at RP2D determined in Part 2.

Primary Outcome Measure

Part 1,2 and 3 : Treatment Emergent Adverse Events (TEAE'S) [ Time Frame: Approximately 2 years ]

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