Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
study ends around

Description

Summary

A study to evaluate the safety and tolerability of INCA036873 in participants with advanced solid tumors and hematological malignancies.

Official Title

A Phase 1, Open-Label, Multicenter Study of INCA036873 in Participants With Advanced Solid Tumors and Hematological Malignancies

Keywords

Solid Tumors, Hematologic Malignancies, 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, Hematologic Neoplasms, Renal Cell Carcinoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, T-Cell, Peripheral, Lymphoma, T-Cell, Cutaneous, Non-Hodgkin Lymphoma, INCA036873

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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/Exclusion Criteria may apply.

Locations

  • University of California San Diego Medical Center, Moores Cancer Center not yet accepting patients
    La Jolla California 92037 United States
  • City of Hope Medical Center not yet accepting patients
    Duarte California 91010 United States
  • Scri Oncology Partners accepting new patients
    Nashville Tennessee 37203 United States
  • Vanderbilt Medical Center not yet accepting patients
    Nashville Tennessee 37232 United States
  • Macquarie University Hospital accepting new patients
    Sydney New South Wales 02109 Australia
  • Princess Alexandra Hospital Australia not yet accepting patients
    Woolloongabba Queensland 04102 Australia
  • Cancer Research Sa not yet accepting patients
    Adelaide South Australia 05000 Australia
  • Peter Maccallum Cancer Centre-Royal Melbourne Hospital accepting new patients
    Melbourne Victoria 03000 Australia

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Incyte Corporation
Links
A Study to Evaluate INCA036873 in Participants With Advanced Solid Tumors and Hematological Malignancies
ID
NCT07195916
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 280 study participants
Last Updated