Hematologic Malignancies, Solid Tumors
Conditions
Keywords
Advanced solid tumors, Metastatic solid tumors, Clear cell renal cell carcinoma (ccRCC), Diffuse large B-cell lymphoma (DLBCL), High-grade B-cell lymphoma (HGBCL), Peripheral T-cell lymphoma (PTCL, incl. ALCL), Cutaneous T-cell lymphoma (CTCL, incl. MF and SS), Non-Hodgkin lymphoma (NHL), CD70, Bispecific antibody, Immunotherapy, T-cell engager
Brief summary
A study to evaluate the safety and tolerability of INCA036873 in participants with advanced solid tumors and hematological malignancies.
Interventions
DRUGINCA036873
Intravenously (IV)
Sponsors
Incyte Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years. * ECOG performance status of 0 or 1. * Histologically confirmed: * Clear cell renal cell carcinoma (ccRCC). * Diffuse large B-cell lymphoma (DLBCL, NOS). * High-grade B-cell lymphoma (HGBCL). * Peripheral T-cell lymphoma (PTCL, incl. NOS and ALCL). * Cutaneous T-cell lymphoma (CTCL, incl. MF or SS ≥Stage IIB with B0/B1 blood involvement). * Disease progression, relapse, or refractory to prior therapy: * ccRCC: ≥1 prior line incl. ICI + TKI. * DLBCL/HGBCL: ≥2 prior lines incl. immunochemotherapy and salvage. * PTCL/CTCL: ≥1 prior systemic therapy. * Measurable disease by RECIST v1.1 (ccRCC), Lugano 2014 (lymphomas), or ISCL/USCLC/EORTC (CTCL). * Tumor tissue available for central testing.
Exclusion criteria
* Untreated or progressive CNS disease unless previously treated and stable. * Other active invasive malignancy within 2 years (except certain low-risk cancers). * Prior CD70-targeting therapy, including CAR T. * ASCT or CAR T ≤12 weeks before enrollment; prior organ or allogeneic transplant. * Unresolved ≥Grade 2 toxicity from prior therapy (with exceptions). * Primary immunodeficiency or active autoimmune disease requiring immunosuppression. * Active HBV, HCV, HIV, or other chronic infections requiring systemic therapy. * Pregnancy, breastfeeding, or unwillingness to use effective contraception. Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1A : Occurrence of Dose Limiting Toxicities (DLTs) | Up to Day 28 | Toxicities occurring during the first study drug infusion and continues through 28 days as defined in the protocol. DLTs will be assessed for severity by the investigator using CTCAE v5.0 criteria. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Up to approximately 2 years and 90 days | TEAE is any Adverse Event (AE) either reported for the first time or worsening of a pre-existing event after first dose of study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics Parameter: Cmax of INCA036873 | Up to approximately 2 years and 90 days | Defined as maximum observed plasma concentration of INCA036873. |
| Pharmacokinetics Parameter: Tmax of INCA036873 | Up to approximately 2 years and 90 days | Defined as the time to reach the maximum plasma concentration of INCA036873. |
| Pharmacokinetics Parameter: Cmin of INCA036873 | Up to approximately 2 years and 90 days | Defined as the minimum observed plasma concentration of INCA036873. |
| Pharmacokinetics Parameter: AUC(0-t) of INCA036873 | Up to approximately 2 years and 90 days | Defined as the area under the concentration-time curve up to the last measurable concentration of INCA036873. |
| Pharmacokinetics Parameter: AUC 0-∞ of INCA036873 | Up to approximately 2 years and 90 days | Defined as the area under the concentration-time curve from 0 to infinity of INCA036873. |
| Pharmacokinetics Parameter: CL of INCA036873 | Up to approximately 2 years and 90 days | Defined as the apparent oral dose clearance of INCA036873. |
| Pharmacokinetics Parameter: Vz of INCA036873 | Up to approximately 2 years and 90 days | Defined as the apparent oral dose volume of distribution of INCA036873. |
| Pharmacokinetics Parameter: t1/2 of INCA036873 | Up to approximately 2 years and 90 days | Defined as the apparent terminal phase disposition half-life of INCA036873. |
| Objective response | Up to approximately 2 years | Defined as a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR), as assessed by the investigator. |
| Disease control | Up to approximately 2 years | Defined as a BOR of CR, PR, or Stable Disease (SD), as assessed by the investigator. |
| Duration of Response (DOR) | Up to approximately 2 years | Defined as the time from the earliest date of a documented objective response (CR or PR) to the earliest date of disease progression (per investigator assessment using the appropriate criteria) or death from any cause, whichever occurs first. |
Countries
Australia, Belgium, Denmark, Italy, United States
Contacts
CONTACTIncyte Corporation Call Center (US)
CONTACTIncyte Corporation Call Center (ex-US)
STUDY_DIRECTORIncyte Study Monitor
Incyte Corporation
Outcome results
None listed