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Advanced MalignanciesPhase 1NCT05577182

Study of INCA32459 a LAG-3 and PD-1 Bispecific Antibody in Participants With Select Advanced Malignancies

A Phase 1 study testing INCA32459-101 in people with Advanced Malignancies, run by Incyte Corporation at 13 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a multicenter, open-label, single-arm study to investigate the safety, tolerability, PK, pharmacodynamics and preliminary activity of INCA32459 in participants with selected advanced malignancies. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Malignancies
What is being tested?
INCA32459-101
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
13 sitesin 4 countries
Study dates
5 Jan 2023to 13 Oct 2025
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Histologically or cytologically confirmed advanced malignancies as follows:
  • Part 1 only: Participants with the select advanced malignancies as specified in the protocol.
  • Part 2 only:
  • Cohort 1 only: Participants with Stage III (unresectable) or Stage IV (metastatic) melanoma that is considered nonamenable to curative treatments or procedures.
  • Cohort 2 only: Participants with histologically or cytologically confirmed recurrent/metastatic SCCHN that is PD-L1 positive (CPS ≥ 1) which is not amenable to local therapy with curative intent.
  • Participants must have experienced disease progression after treatment with standard therapies, or are intolerant to or ineligible for standard treatment:
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  • Part 1: All available standard therapies, including anti-PD-(L)1 and platinum-based therapy, if applicable, that are known to confer clinical benefit. Prior anti-PD-(L)1 therapy should not have been discontinued because of intolerance.
  • Part 2: Available standard therapies, including anti-PD-(L)1 and platinum-based therapy, if applicable, that are known to confer clinical benefit. Prior anti-PD-(L)1 therapy should not have been discontinued because of intolerance. Part 2 participants may have received up to 2 prior systemic therapies in the a advanced/metastatic setting.
  • ECOG performance status of 0 or 1
  • Part 2 only: Measurable disease according to RECIST v1.1.
  • Part 2 only: Willingness to undergo a fresh tumor biopsy at screening (core or excisional).
  • Part 2 only: Willingness to undergo a fresh tumor biopsy at screening and on-treatment in selected participant.
  • Willingness to avoid pregnancy or fathering children

Who cannot join

  • Prior treatment with any LAG-3- or MHC Class II-directed therapy for current malignancy, or any prior malignancy.
  • Treatment with anticancer therapies or participation in another interventional clinical study within 28 days before the first administration of study treatment (this includes curative radiation to the thorax or systemic anticancer therapies).
  • Not recovered to ≤ Grade 1 or baseline from residual toxicities of prior therapy (with exceptions specified in the protocol).
  • Not recovered adequately from toxicities and/or complications from surgical intervention before starting study treatment.
  • Palliative radiation therapy administered within 1 week of first dose of study treatment or radiation therapy in the thoracic region that is > 30 Gy within 6 months of the first dose of study treatment.
  • Any known additional malignancy that is progressing or requires active treatment; history of other malignancy within 3 years of the first dose of study treatment (with exceptions specified in the protocol).
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  • Evidence of interstitial lung disease or history of interstitial lung disease, or active, noninfectious pneumonitis.
  • Active autoimmune disease requiring systemic immunosuppression with corticosteroids (> 10 mg/day of prednisone or equivalent) or immunosuppressive drugs within 2 years before the first dose of study treatment.
  • Untreated brain or CNS metastases or brain or CNS metastases that have progressed (eg, evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain or CNS metastases).
  • Chronic treatment with systemic steroids (> 10 mg/day of prednisone or equivalent).

Trial locations and contacts

13 sites in 4 countries.

13 sites in 4 countries

Belgium5 sites

  • Cliniques Universitaires Ucl Saint-Luc

    Brussels, 01200

  • Universitair Ziekenhuis Antwerpen (Uza)

    Edegem, 02650

  • Universitair Ziekenhuis Gent

    Ghent, 09000

  • Universitair Ziekenhuis Brussel

    Jette, 01090

  • Chu Ucl Namur University Hospital Mont-Godinne

    Yvoir, 05530

Other trials in Belgium

Spain5 sites

  • Hospital Quironsalud Barcelona

    Barcelona, 08023

  • Ico Institut Catala D Oncologia

    L'Hospitalet de Llobregat, 08906

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Centro Integral Oncologico Clara Campal

    Madrid, 28050

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón, 28223

Other trials in Spain

United States2 sites

  • University of Texas Md Anderson Cancer Center

    Houston, Texas, 77030

  • The Angeles Clinic and Research Institute

    Los Angeles, California, 90025

Other trials in United States

Italy1 site

  • Centro Ricerche Cliniche Di Verona (Crc)

    Verona, 37134

Other trials in Italy

About this study

Official title: A Phase 1, Open-Label, Multicenter Study of INCA32459 in Participants With Select Advanced Malignancies

This is a multicenter, open-label, single-arm study to investigate the safety, tolerability, PK, pharmacodynamics and preliminary activity of INCA32459 in participants with selected advanced malignancies. Part 1 (dose escalation) will determine the recommended dose of INCA 32459 for expansion (RDE) and the maximum tolerated dose (MTD). Part 2 (dose expansion) will further evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary antitumor activity of INCA 32459 at the recommended dose(s) for expansion in 2 tumor-specific cohorts.

Being tested
INCA32459-101
Keywords
LAG-3, bispecific antibody, melanoma, squamous cell carcinoma of the head and neck (SCCHN)
Medical subject headings
Melanoma, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INCA32459-101Drug

    solution for infusion

Study groups in NCT05577182
Study groupRoleWhat they receive
Part 1: Dose EscalationExperimentalINCA32459 will be administered at a protocol defined starting regimen intravenously. Subsequent dose regimens will be determined during study conduct.
Receives: Drug: INCA32459-101
Part 2: Dose Expansion Cohort Disease Group 1ExperimentalINCA32459 will be administered at the recommended dose or doses for expansion (RDE[s]) for unresectable or metastatic melanoma.
Receives: Drug: INCA32459-101
Part 2: Dose Expansion Cohort Disease Group 2ExperimentalINCA32459 will be administered at the recommended dose or doses for expansion (RDE[s]) for recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) that is PD-L1 positive.
Receives: Drug: INCA32459-101

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Toxicities occurring during Part 1 will define tolerability. DLTs will be assessed for severity by the investigator using CTCAE v5.0 criteria.

    Measured: Up to approximately 12 months

  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.

    Measured: Up to approximately 12 months

  3. Number of Participants with Dose Interruptions due to TEAE

    Dose interruptions will occur according to protocol guidelines.

    Measured: Up to approximately 12 months

  4. Number of Participants discontinue study due to TEAE

    TEAE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

    Measured: Up to approximately 12 months

Secondary outcomes (11)

  1. Objective Response Rate (ORR)

    Defined as having Complete Response (CR) or Partial Response (PR), as determined by the investigator by radiographic disease assessment according to RECIST v1.1 or Lugano criteria (B-cell lymphomas only).

    Measured: Up to 12 months

  2. Disease Control Response (DCR)

    Defined as having CR, PR, or Stable Disease (SD) as determined by the investigator by radiographic disease assessment according to RECIST v1.1. or Lugano criteria (B-cell lymphomas only).

    Measured: Up to 12 months

  3. Duration of Response (DOR)

    Defined as the time from earliest date of disease response (Completed Response or Partial Response) until earliest date of disease progression as determined by the investigator by radiographic disease assessment according to RECIST v1.1 or Lugano criteria (B-cell lymphomas only) or death due to any cause if occurring sooner than progression.

    Measured: Up to 12 months

  4. PK parameters: Cmax

    Defined as the maximum (peak) plasma drug concentration

    Measured: Up to 24 months

  5. PK parameters: tmax

    Defined as the time to reach maximum (peak) plasma concentration following drug administration

    Measured: Up to 24 months

  6. PK parameters: Cmin

    Defined as concentration at the end of the dosing interval

    Measured: Up to 24 months

  7. PK Parameters: AUC

    Defined as the area under the plasma concentration-time curve

    Measured: Up to 24 months

  8. PK Parameters: CL

    Defined as the apparent total body clearance of the drug from plasma

    Measured: Up to 24 months

  9. PK Parameters: Vz

    Defined as apparent volume of distribution during terminal phase

    Measured: Up to 24 months

  10. PK Parameters: t1/2

    Defined as Elimination half-life (to be used in one-or noncompartmental model)

    Measured: Up to 24 months

  11. Receptor Occupancy

    Defined as PD-1 receptor occupancy in peripheral blood samples.

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2022
  2. Study start5 Jan 2023
  3. Primary completion13 Oct 2025
  4. Study completion13 Oct 2025

Resources

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
Model description
Part 1 will be dose escalation using a statistical hybrid design to identify the RDE(s). Part 2 will be dose expansion portion which will administer the RDE(s) defined in Part 1 to participants in 2 tumor-specific cohorts.
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05577182
Sponsor's protocol ID
INCA 32459-101
Other IDs
2022-501505-13-00
Status last verified
Oct 2025
First submitted
7 Oct 2022
Last updated
3 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing INCA32459-101 in people with Advanced Malignancies, run by Incyte Corporation at 13 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Belgium, Spain, United States, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Occurrence of Dose Limiting Toxicities (DLTs) (time frame: Up to approximately 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05577182.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2025.

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