Actively Recruiting

Phase 1
Age: 18Years +
All Genders
ID07195916

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

Led by Incyte Corporation · Updated on 2026-05-04

280

Participants Needed

22

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and tolerability of INCA036873 in adults with advanced solid tumors and blood cancers, including clear cell renal cell carcinoma and various types of lymphoma. This early phase 1 study is designed to assess how the drug behaves in the body and to monitor any side effects, helping to understand its potential for treating these difficult conditions. Participants will receive INCA036873 intravenously at doses defined by the study protocol. The study includes several parts: dose escalation to find the appropriate dose, dose expansion to further evaluate safety, and a pharmacodynamic cohort to study the drug's effects. The treatment is given according to these phases, and all participants receive the investigational drug without placebo comparison. Throughout the study, participants will undergo regular assessments including scans and blood tests to measure disease status and drug levels. Researchers will track dose limiting toxicities during the first 28 days and monitor treatment-emergent adverse events for up to about two years and 90 days. They will also measure how the drug is processed in the body and evaluate disease response over time, ensuring careful safety monitoring during and after treatment.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • ECOG performance status of 0 or 1
  • Histologically confirmed clear cell renal cell carcinoma, diffuse large B-cell lymphoma, high-grade B-cell lymphoma, peripheral T-cell lymphoma (including NOS and ALCL), or cutaneous T-cell lymphoma (including MF or SS stage IIB or higher with B0/B1 blood involvement)
  • Disease progression, relapse, or refractory to prior therapy (at least 1 prior line including ICI + TKI for ccRCC; at least 2 prior lines including immunochemotherapy and salvage for DLBCL/HGBCL; at least 1 prior systemic therapy for PTCL/CTCL)
  • Measurable disease by RECIST v1.1, Lugano 2014, or ISCL/USCLC/EORTC criteria
  • Tumor tissue available for central testing
Not Eligible

You will not qualify if you...

  • Untreated or progressive central nervous system 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-cell therapy
  • Autologous stem cell transplant or CAR T-cell therapy within 12 weeks before enrollment
  • Prior organ or allogeneic transplant
  • Unresolved grade 2 or higher toxicity from prior therapy with exceptions
  • Primary immunodeficiency or active autoimmune disease requiring immunosuppression
  • Active hepatitis B, hepatitis C, HIV, or other chronic infections requiring systemic therapy
  • Pregnancy, breastfeeding, or unwillingness to use effective contraception
  • Other protocol-defined criteria may apply

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to approximately 2 years and 90 days

Participants receive INCA036873 administered intravenously at the protocol defined dose.

Visits occur regularly during treatment as per protocol

Trial Site Locations

Total: 22 locations

1

City of Hope Medical Center

Duarte, California, United States, 91010

Actively Recruiting

2

University of California San Diego Medical Center, Moores Cancer Center

La Jolla, California, United States, 92037

Not Yet Recruiting

3

University of Michigan

Ann Arbor, Michigan, United States, 48109

Not Yet Recruiting

4

The University of Nebraska Medical Center

Omaha, Nebraska, United States, 68198

Not Yet Recruiting

5

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10021

Not Yet Recruiting

6

Scri Oncology Partners

Nashville, Tennessee, United States, 37203

Actively Recruiting

7

Vanderbilt Medical Center

Nashville, Tennessee, United States, 37232

Not Yet Recruiting

8

Md Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

9

Macquarie University Hospital

Sydney, New South Wales, Australia, 02109

Actively Recruiting

10

Princess Alexandra Hospital Australia

Woolloongabba, Queensland, Australia, 04102

Actively Recruiting

11

Cancer Research Sa

Adelaide, South Australia, Australia, 05000

Actively Recruiting

12

Peter Maccallum Cancer Centre-Royal Melbourne Hospital

Melbourne, Victoria, Australia, 03000

Actively Recruiting

13

Cliniques Universitaires Ucl Saint-Luc

Brussels, Belgium, 01200

Not Yet Recruiting

14

Universitair Ziekenhuis Antwerpen

Edegem, Belgium, 02650

Not Yet Recruiting

15

Universitair Ziekenhuis Gent (Uz Gent)

Ghent, Belgium, 09000

Not Yet Recruiting

16

Universitair Ziekenhuis Leuven

Leuven, Belgium, 03000

Not Yet Recruiting

17

Aarhus University Hospital

Aarhus, Denmark, 08200

Not Yet Recruiting

18

Rigshospitalet Uni of Hospital of Copenhagen

Copenhagen, Denmark, DK-2100

Not Yet Recruiting

19

Aou Policlinico S. Orsola-Malpighi

Bologna, Italy, 40138

Not Yet Recruiting

20

Fondazione Irccs Istituto Nazionale Dei Tumori

Milan, Italy, 20133

Not Yet Recruiting

21

Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore

Rome, Italy, 00168

Not Yet Recruiting

22

Centro Ricerche Cliniche Di Verona

Verona, Italy, 37134

Not Yet Recruiting

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Research Team

I

Incyte Corporation Call Center (US)

I

Incyte Corporation Call Center (ex-US)

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

3

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