Solid TumorsPhase 1NCT07195916
A Study to Evaluate INCA036873 in Participants With Advanced Solid Tumors and Hematological Malignancies
A Phase 1 study testing INCA036873 in people with Solid Tumors and Hematologic Malignancies, run by Incyte Corporation at 22 sites in 5 countries.
Trial summary
A study to evaluate the safety and tolerability of INCA036873 in participants with advanced solid tumors and hematological malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Hematologic Malignancies
- What is being tested?
- INCA036873
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 22 sitesin 5 countries
- Study dates
- 8 Jan 2026to 18 Aug 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
22 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
22 sites in 5 countries
United States8 sites, 8 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
- Recruiting
City of Hope Medical Center
Duarte, California, 91010
- Recruiting
Md Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
University of California San Diego Medical Center, Moores Cancer Center
La Jolla, California, 92037
- Recruiting
Scri Oncology Partners
Nashville, Tennessee, 37203
- Recruiting
Vanderbilt Medical Center
Nashville, Tennessee, 37232
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
- Recruiting
The University of Nebraska Medical Center
Omaha, Nebraska, 68198
Australia4 sites, 4 recruiting
- Recruiting
Cancer Research Sa
Adelaide, South Australia, 05000
- Recruiting
Peter Maccallum Cancer Centre-Royal Melbourne Hospital
Melbourne, Victoria, 03000
- Recruiting
Macquarie University Hospital
Sydney, New South Wales, 02109
- Recruiting
Princess Alexandra Hospital Australia
Woolloongabba, Queensland, 04102
Belgium4 sites, 4 recruiting
- Recruiting
Cliniques Universitaires Ucl Saint-Luc
Brussels, 01200
- Recruiting
Universitair Ziekenhuis Antwerpen
Edegem, 02650
- Recruiting
Universitair Ziekenhuis Gent (Uz Gent)
Ghent, 09000
- Recruiting
Universitair Ziekenhuis Leuven
Leuven, 03000
Italy4 sites, 4 recruiting
- Not yet recruiting
Aou Policlinico S. Orsola-Malpighi
Bologna, 40138
- Not yet recruiting
Fondazione Irccs Istituto Nazionale Dei Tumori
Milan, 20133
- Not yet recruiting
Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore
Rome, 00168
- Recruiting
Centro Ricerche Cliniche Di Verona
Verona, 37134
Denmark2 sites, 2 recruiting
- Recruiting
Department of Hematology'S Research Unit and Laboratories At Aarhus University Hospital
Aarhus, 08200
- Recruiting
Rigshospitalet Uni of Hospital of Copenhagen
Copenhagen, DK-2100
About this study
Official title: A Phase 1, Open-Label, Multicenter Study of 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.
- Conditions
- Solid Tumors, Hematologic Malignancies
- Being tested
- INCA036873
- Keywords
- 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
- Medical subject headings
- Hematologic Neoplasms, Carcinoma, Renal Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, T-Cell, Peripheral, Lymphoma, T-Cell, Cutaneous, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCA036873Drug
Intravenously (IV)
| Study group | Role | What they receive |
|---|---|---|
| Part 1a Dose Escalation | Experimental | INCA036873 will be administered at the protocol defined dose. Receives: Drug: INCA036873 |
| Part 1b Dose Expansion | Experimental | INCA036873 will be administered at the protocol defined dose. Receives: Drug: INCA036873 |
| Part 1c Pharmacodynamic Cohort | Experimental | INCA036873 will be administered at the protocol defined dose. Receives: Drug: INCA036873 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1A : Occurrence of Dose Limiting Toxicities (DLTs)
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.
Measured: Up to Day 28
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
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.
Measured: Up to approximately 2 years and 90 days
Secondary outcomes (11)
Pharmacokinetics Parameter: Cmax of INCA036873
Defined as maximum observed plasma concentration of INCA036873.
Measured: Up to approximately 2 years and 90 days
Pharmacokinetics Parameter: Tmax of INCA036873
Defined as the time to reach the maximum plasma concentration of INCA036873.
Measured: Up to approximately 2 years and 90 days
Pharmacokinetics Parameter: Cmin of INCA036873
Defined as the minimum observed plasma concentration of INCA036873.
Measured: Up to approximately 2 years and 90 days
Pharmacokinetics Parameter: AUC(0-t) of INCA036873
Defined as the area under the concentration-time curve up to the last measurable concentration of INCA036873.
Measured: Up to approximately 2 years and 90 days
Pharmacokinetics Parameter: AUC 0-∞ of INCA036873
Defined as the area under the concentration-time curve from 0 to infinity of INCA036873.
Measured: Up to approximately 2 years and 90 days
Pharmacokinetics Parameter: CL of INCA036873
Defined as the apparent oral dose clearance of INCA036873.
Measured: Up to approximately 2 years and 90 days
Pharmacokinetics Parameter: Vz of INCA036873
Defined as the apparent oral dose volume of distribution of INCA036873.
Measured: Up to approximately 2 years and 90 days
Pharmacokinetics Parameter: t1/2 of INCA036873
Defined as the apparent terminal phase disposition half-life of INCA036873.
Measured: Up to approximately 2 years and 90 days
Objective response
Defined as a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR), as assessed by the investigator.
Measured: Up to approximately 2 years
Disease control
Defined as a BOR of CR, PR, or Stable Disease (SD), as assessed by the investigator.
Measured: Up to approximately 2 years
Duration of Response (DOR)
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.
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start8 Jan 2026
- Primary completion18 Aug 2028 (estimated)
- Study completion18 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Incyte Study Monitor, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195916
- Sponsor's protocol ID
- INCA036873-101
- Other IDs
- 2025-523130-11-00, 2025
- Status last verified
- Oct 2026
- First submitted
- 19 Sep 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No