ClinicalTrials.gg
RecruitingNCT07195916Updated Oct 9, 2026

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

A Phase 1 interventional study of INCA036873 in Solid Tumors and Hematologic Malignancies, sponsored by Incyte Corporation. Recruiting at 22 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.

Sponsored by Incyte Corporation · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2026; still recruiting 10 months later.
Updated Oct 9, 2026Site recruiting status changed1 site added+1 moreGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
280
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 821 studies in Hematologic Neoplasms with a site in United States — 181 open to participants now, 276 under way, 12 of them phase 3. Hematologic Neoplasms · United States.

Planned enrollment
59th of 658
280 · median 40
Started
2026
with 37 others
Phase 1
195 of 821
35 open now
Primary completion
2028-08
later than 190 of 273 live
Registered
793rd of 821
by date

Among the 821 studies in Hematologic Neoplasms with a site in United States, this one is the 59th largest by planned enrollment of the 658 interventional ones that give a count, is one of 38 that started in 2026, is one of 195 in phase 1, reaches primary completion later than 190 of the 273 other live ones, and was the 793rd registered.

Hematologic Neoplasms

1,444 studies on the registry are indexed under Hematologic Neoplasms; 420 are open to participants now.

Browse Hematologic Neoplasms studies →

Open to participants now

181 of the 821 studies in Hematologic Neoplasms with a site in United States are open now. Recruiting first, the newest first:

176 more — sign in →

All 181 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 313 Hematologic Neoplasms studies recruiting now, 208 (66%) set no upper age limit and 78 (25%) stop at 75 or younger; 80 take children under 18; 34 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study summary

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

03

Conditions studied

  • Solid Tumors
  • Hematologic Malignancies

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
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥18 years.
  • performance status of 0 or 1.
  • 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 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.
  • by v1.1 (ccRCC), Lugano 2014 (lymphomas), or ISCL/USCLC/EORTC (CTCL).
  • Tumor tissue available for central testing.

Exclusion criteria

Exclusion Criteria:

  • Untreated or progressive CNS disease unless previously treated and stable.
  • Other active invasive within 2 years (except certain low-risk cancers).
  • Prior CD70-targeting therapy, including CAR T.
  • 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 disease requiring .
  • Active , , , or other chronic infections requiring systemic therapy.
  • Pregnancy, breastfeeding, or unwillingness to use effective .

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Terms in these criteria, in plain language(13)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
280 participants (estimated)

Study arms

  • Experimental
    Part 1a Dose Escalation

    INCA036873 will be administered at the protocol defined dose.

    Drug: INCA036873

  • Experimental
    Part 1b Dose Expansion

    INCA036873 will be administered at the protocol defined dose.

    Drug: INCA036873

  • Experimental
    Part 1c Pharmacodynamic Cohort

    INCA036873 will be administered at the protocol defined dose.

    Drug: INCA036873

Interventions

  • DrugINCA036873

    Intravenously (IV)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to Day 28

  2. 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.

    Time frame: Up to approximately 2 years and 90 days

Secondary outcomes

  1. Pharmacokinetics Parameter: Cmax of INCA036873

    Defined as maximum observed plasma concentration of INCA036873.

    Time frame: Up to approximately 2 years and 90 days

  2. Pharmacokinetics Parameter: Tmax of INCA036873

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

    Time frame: Up to approximately 2 years and 90 days

  3. Pharmacokinetics Parameter: Cmin of INCA036873

    Defined as the minimum observed plasma concentration of INCA036873.

    Time frame: Up to approximately 2 years and 90 days

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

    Defined as the area under the concentration-time curve up to the last measurable concentration of INCA036873.

    Time frame: Up to approximately 2 years and 90 days

  5. Pharmacokinetics Parameter: AUC 0-∞ of INCA036873

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

    Time frame: Up to approximately 2 years and 90 days

  6. Pharmacokinetics Parameter: CL of INCA036873

    Defined as the apparent oral dose clearance of INCA036873.

    Time frame: Up to approximately 2 years and 90 days

  7. Pharmacokinetics Parameter: Vz of INCA036873

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

    Time frame: Up to approximately 2 years and 90 days

  8. Pharmacokinetics Parameter: t1/2 of INCA036873

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

    Time frame: Up to approximately 2 years and 90 days

  9. Objective response

    Defined as a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR), as assessed by the investigator.

    Time frame: Up to approximately 2 years

  10. Disease control

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

    Time frame: Up to approximately 2 years

  11. 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.

    Time frame: Up to approximately 2 years

07

Study locations

19 of 22 sites recruiting
08

References and documents

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2026 (actual). Primary completion is estimated for Aug 2028, 31 months after the start.

Of 95 industry-sponsored phase 1 interventional studies under Hematologic Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 78. This study's planned 31 months is below that.

Counting every sponsor, half of 159 studies reached it within 51 months; a quarter within 28 and three quarters within 78.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 19, 2025
First posted
Sep 29, 2025
StartActual
Jan 8, 2026
Primary completionEst.
Aug 18, 2028
CompletionEst.
Aug 18, 2028
Last update
Oct 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
1 site added, 1 site removed. 2 sites changed recruiting status (2 now recruiting)
Show 2 sites
  • Vanderbilt Medical Center · Nashville, United StatesNot yet recruiting→Recruiting
  • Centro Ricerche Cliniche Di Verona · Verona, ItalyNot yet recruiting→Recruiting
Show site
  • Department of Hematology'S Research Unit and Laboratories At Aarhus University Hospital · Aarhus, Denmark
Show 1 removed
  • Aarhus University Hospital · Aarhus, Denmark
Oct 9, 2026
Show all 1 update
  1. Oct 9, 2026
    1 site added, 1 site removed. 2 sites changed recruiting status (2 now recruiting)
    Show 2 sites
    • Vanderbilt Medical Center · Nashville, United StatesNot yet recruiting→Recruiting
    • Centro Ricerche Cliniche Di Verona · Verona, ItalyNot yet recruiting→Recruiting
    Show site
    • Department of Hematology'S Research Unit and Laboratories At Aarhus University Hospital · Aarhus, Denmark
    Show 1 removed
    • Aarhus University Hospital · Aarhus, Denmark
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07195916
Lead sponsor
Incyte Corporation
Responsible party
Sponsor
First posted
Sep 29, 2025
Start date
Jan 8, 2026
Primary completion
Aug 18, 2028 (estimated)
Completion
Aug 18, 2028 (estimated)
Last update
Oct 9, 2026

Study contacts

Incyte Corporation Call Center (US)
Contact
medinfo@incyte.com
1.855.463.3463
Incyte Corporation Call Center (ex-US)
Contact
eumedinfo@incyte.com
+800 00027423
Incyte Study Monitor
study director · Incyte Corporation

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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