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NCT Number: NCT07195916

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

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

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Key information

Conditions

Solid Tumors Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hematologic Malignancies Hematologic Neoplasms Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Kidney Diseases Kidney Neoplasms Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoma, T-Cell, Peripheral Lymphoproliferative Disorders Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Macquarie University Hospital, Sydney, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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/Exclusion Criteria may apply.

Treatment and study plan

INCA036873

Drug

Intravenously (IV)

Primary outcomes

  1. Part 1A : Occurrence of Dose Limiting Toxicities (DLTs)

    Time frame: 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.

  2. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Time frame: 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 outcomes

  1. Pharmacokinetics Parameter: Cmax of INCA036873

    Time frame: Up to approximately 2 years and 90 days

    Defined as maximum observed plasma concentration of INCA036873.

  2. Pharmacokinetics Parameter: Tmax of INCA036873

    Time frame: Up to approximately 2 years and 90 days

    Defined as the time to reach the maximum plasma concentration of INCA036873.

  3. Pharmacokinetics Parameter: Cmin of INCA036873

    Time frame: Up to approximately 2 years and 90 days

    Defined as the minimum observed plasma concentration of INCA036873.

  4. Pharmacokinetics Parameter: AUC(0-t) of INCA036873

    Time frame: 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.

  5. Pharmacokinetics Parameter: AUC 0-∞ of INCA036873

    Time frame: Up to approximately 2 years and 90 days

    Defined as the area under the concentration-time curve from 0 to infinity of INCA036873.

  6. Pharmacokinetics Parameter: CL of INCA036873

    Time frame: Up to approximately 2 years and 90 days

    Defined as the apparent oral dose clearance of INCA036873.

  7. Pharmacokinetics Parameter: Vz of INCA036873

    Time frame: Up to approximately 2 years and 90 days

    Defined as the apparent oral dose volume of distribution of INCA036873.

  8. Pharmacokinetics Parameter: t1/2 of INCA036873

    Time frame: Up to approximately 2 years and 90 days

    Defined as the apparent terminal phase disposition half-life of INCA036873.

  9. Objective response

    Time frame: 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.

  10. Disease control

    Time frame: Up to approximately 2 years

    Defined as a BOR of CR, PR, or Stable Disease (SD), as assessed by the investigator.

  11. Duration of Response (DOR)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Incyte Corporation Call Center (US)

CONTACT

[email protected]

1.855.463.3463

Incyte Corporation Call Center (ex-US)

CONTACT

[email protected]

+800 00027423

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 29, 2025
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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