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Recruiting Phase 1

A Study to Evaluate INCA036873 in Participants With Advanced Solid Tumors and Hematological Malignancies

About this study

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

Condition
Solid Tumors, Hematologic Malignancies
Tested
INCA036873
Sponsor
Incyte Corporation

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 16

  • Minimum age: 18 years
  • Study condition: Solid Tumors, Hematologic Malignancies
  • 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 9

  • 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.

Where

22 sites, 22 recruiting

Cancer Research Sa

Adelaide, South Australia, Australia

Recruiting

Peter Maccallum Cancer Centre-Royal Melbourne Hospital

Melbourne, Victoria, Australia

Recruiting

Macquarie University Hospital

Sydney, New South Wales, Australia

Recruiting

Princess Alexandra Hospital Australia

Woolloongabba, Queensland, Australia

Recruiting

Cliniques Universitaires Ucl Saint-Luc

Brussels, Belgium

Recruiting

Universitair Ziekenhuis Antwerpen

Edegem, Belgium

Recruiting

and 16 more sites on ClinicalTrials.gov

Contact

Potential match only. Final eligibility is determined by the study team.