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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-08

Study Completion Date

2028-08-18

Brief Summary

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

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Detailed Description

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Conditions

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Solid Tumors Hematologic Malignancies

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1a Dose Escalation

INCA036873 will be administered at the protocol defined dose.

Group Type EXPERIMENTAL

INCA036873

Intervention Type DRUG

Intravenously (IV)

Part 1b Dose Expansion

INCA036873 will be administered at the protocol defined dose.

Group Type EXPERIMENTAL

INCA036873

Intervention Type DRUG

Intravenously (IV)

Part 1c Pharmacodynamic Cohort

INCA036873 will be administered at the protocol defined dose.

Group Type EXPERIMENTAL

INCA036873

Intervention Type DRUG

Intravenously (IV)

Interventions

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INCA036873

Intravenously (IV)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Incyte Study Monitor

Role: STUDY_DIRECTOR

Incyte Corporation

Locations

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