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Advanced Solid TumorsPhase 1/2NCT05949632

A Study of INCB099280 in Combination With Axitinib in Adults With Advanced Solid Tumors

A Phase 1/2 study testing INCB099280 and axitinib in people with Advanced Solid Tumors, run by Incyte Corporation at 6 sites in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study is being conducted to evaluate the safety and tolerability of INCB099280 in combination with axitinib and to assess the antitumor activity of INCB099280 in combination with axitinib. This study will only be open in the UK and EU. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Advanced Solid Tumors
What is being tested?
INCB099280 and axitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
6 sitesUnited Kingdom
Study dates
16 Apr 2024to 6 Jun 2025
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed advanced solid tumors (protocol-defined select solid tumors) with measurable lesions per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) that are considered non-amenable to surgery or other curative treatments or procedures.
  • Must have disease progression on or after treatment with at least one prior systemic chemotherapy.
  • Eastern Cooperative Oncology Group performance status score of 0 or 1.
  • Life expectancy > 12 weeks.
  • Willingness to avoid pregnancy.

Who cannot join

  • Known additional malignancy that is progressing or requires active treatment.
  • Central nervous system (CNS) metastases requiring treatment and/or leptomeningeal disease.
  • Toxicity from prior therapy that has not recovered to protocol-defined limits.
  • Prior receipt of an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent; treatment with an immune modulator (eg, CTLA-4, GITR, LAG3, TIM3, OX40, ICOS, IL-2, 4-1BB, CAR-T cell).
  • Prior therapy with antiangiogenic small-molecule TKIs targeting the VEGF pathway
  • Participation in another interventional clinical study while receiving INCB099280.
Show all 19Show fewer
  • Impaired cardiac function or clinically significant cardiac disease.
  • History or evidence of interstitial lung disease including noninfectious pneumonitis.
  • Presence of gastrointestinal conditions that may affect drug absorption.
  • Any autoimmune disease requiring systemic treatment in the past 5 years.
  • Diagnosis of primary immunodeficiency or receiving chronic systemic steroid therapy at a daily dose exceeding 10 mg of prednisone or equivalent.
  • Active infection requiring systemic therapy.
  • History of organ transplantation, including stem cell transplantation.
  • Receipt of systemic antibiotics within 28 days of first dose of study treatment.
  • Probiotic usage is prohibited during screening and throughout the study treatment period.
  • Received a live vaccine within 28 days of the planned start of study drug.
  • Laboratory values outside the Protocol-defined ranges.
  • Inadequate organ function.
  • Other protocol-defined Inclusion/Exclusion Criteria may apply.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United Kingdom6 sites

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ

  • Beatson West of Scotland Cancer Centrewester

    Glasgow, G12 0YN

  • St Bartholomew'S Hospital

    London, EC1A 7BE

  • Guys Hospital

    London, SE1 9RT

  • The Royal Marsden

    London, SW3 6JJ

  • The Royal Marsden Nhs Foundation Trust - Sutton

    Sutton, SM2 5PT

Other trials in United Kingdom

About this study

Official title: A Phase 1/2 Study of INCB099280 in Combination With Axitinib in Adults With Advanced Solid Tumors

This study is being conducted to evaluate the safety and tolerability of INCB099280 in combination with axitinib and to assess the antitumor activity of INCB099280 in combination with axitinib. This study will only be open in the UK and EU.

Being tested
INCB099280, axitinib
Keywords
gynecologic tract cancer, ovarian cancer, primary peritoneum cancer, fallopian tube cancer, uterine cancer, cervical cancer, vulvar cancer, vaginal cancer, clear cell histology, mucinous adenocarcinoma, carcinosarcoma, serous adenocarcinoma, neuroendocrine histology, small cell histology, small-molecule pdl1 inhibitor, tyrosine kinase inhibitor, combination therapy
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms, Uterine Neoplasms, Uterine Cervical Neoplasms, Vulvar Neoplasms, Vaginal Neoplasms, Adenocarcinoma, Mucinous, Carcinosarcoma

What participants receive

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

  • INCB099280Drug

    Administered as specified in the treatment arm description

  • axitinibDrug

    Administered as specified in the treatment arm description

Study groups in NCT05949632
Study groupRoleWhat they receive
Part 1: Dose EscalationExperimentalUp to 6 doses of INCB099280 administered twice daily (BID) in combination with axitinib BID will be evaluated to identify dose(s) for further evaluation in the dose expansion phase of the study.
Receives: Drug: INCB099280; Drug: axitinib
Part 2: Dose ExpansionExperimentalOn completion of Part 1, participants will be enrolled in 1 of 2 disease-specific cohorts: Cohort 1: Adults with clear-cell gynecological cancers with at least 50% clear-cell histology whose disease progressed on or following at least 1 prior line of systemic chemotherapy and are not candidates for curative surgery or (chemo)radiation. Cohort 2: Adults with rare histological subtype epithelial cancers of the gynecological tract whose disease progressed on or following at least 1 prior line of systemic chemotherapy and are not candidates for curative surgery or (chemo)radiation. One or two doses may be selected from Part 1 for each cohort in the Part 2 Expansion.
Receives: Drug: INCB099280; Drug: axitinib

What is being measured

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

  1. Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)

    Any adverse event that ws at least possibly related to study treatment and met protocol-specified criteria was classified as a DLT. For the purpose of dose finding, decisions on dose were based on DLTs observed during the first 21 days of treatment.

    Measured: up to 3 weeks

  2. Part 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)

    An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE therefore could have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE that was either reported for the first time or the worsening of a pre-existing event after the first dose of either study drug until 104 days after the last dose of study treatment or the start of new anticancer therapy.

    Measured: up to approximately 1 year

  3. Part 1: Number of Participants With TEAEs Leading to a Dosing Modification (Treatment Interruption, Dose Reduction, and Permanent Discontinuation of Either Study Drug)

    An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE therefore could have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE that was either reported for the first time or the worsening of a pre-existing event after the first dose of either study drug until 104 days after the last dose of study treatment or the start of new anticancer therapy.

    Measured: up to approximately 1 year

  4. Part 2: Objective Response

    Objective response was defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) by investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.

    Measured: up to 2 years

Secondary outcomes (17)

  1. Part 2: Number of Participants With Any TEAE

    An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE therefore could have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE that was either reported for the first time or the worsening of a pre-existing event after the first dose of either study drug until 104 days after the last dose of study treatment or the start of new anticancer therapy.

    Measured: up to 2 years

  2. Part 2: Number of Participants With TEAEs Leading to a Dosing Modification (Treatment Interruption, Dose Reduction, and Permanent Discontinuation of Either Study Drug)

    An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE therefore could have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE that was either reported for the first time or the worsening of a pre-existing event after the first dose of either study drug until 104 days after the last dose of study treatment or the start of new anticancer therapy.

    Measured: up to 2 years

  3. Part 1: Objective Response

    Objective response was defined as the percentage of participants with a BOR of CR or PR by investigator assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.

    Measured: up to 335 days

  4. Part 1: Disease Control

    Disease control was defined as the percentage of participants with a BOR of CR, PR, or stable disease (SD) by investigator assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.

    Measured: up to 335 days

  5. Part 1: Duration of Response (DOR)

    DOR was defined as the time from the first CR or PR until disease progression by investigator assessment per RECIST v1.1 or death from any cause, whichever occurred earlier. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.

    Measured: up to 335 days

  6. Part 1: INCB099280 and Axitinib Plasma Concentrations

    Blood samples were collected for the analysis of INCB099280 and axitinib concentrations. Per Protocol, PK samples for axitinib were only to be analyzed in case of a concern that axitinib was not as active as expected. Due to the early termination of the study before readout, these samples were not analyzed.

    Measured: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample

  7. Part 1: Cmax of INCB099280 When Administered With Axitinib

    Cmax was defined as the maximum observed concentration of INCB099280.

    Measured: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample

  8. Part 1: Tmax of INCB099280 When Administered With Axitinib

    tmax was defined as the time to the maximum concentration of INCB099280.

    Measured: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample

  9. Part 1: AUC0-4h of INCB099280 When Administered With Axitinib

    AUC0-4h was defined as area under the steady-state plasma or serum concentration-time curve from 0 to 4 hours.

    Measured: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample

  10. Part 1: Cmax,ss of INCB099280 When Administered With Axitinib

    Cmax,ss was defined as the maximum observed concentration at steady state.

    Measured: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample

  11. Part 1: Tmax,ss of INCB099280 When Administered With Axitinib

    tmax,ss was defined as the time to the maximum concentration of INCB099280 at steady state.

    Measured: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample

  12. Part 1: AUC0-12h of INCB099280 When Administered With Axitinib

    AUC0-12h was defined as the area under the steady-state plasma or serum concentration-time curve from 0 to 12 hours.

    Measured: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample

  13. Part 1: Cavg of INCB099280 When Administered With Axitinib

    Cavg was defined as the average concentration of INCB099280.

    Measured: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample

  14. Part 1: Ctau of INCB099280 When Administered With Axitinib

    Ctau was defined as the concentration of INCB099280 at the end of a dose interval.

    Measured: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample

  15. Part 1: t1/2 of INCB099280 When Administered With Axitinib

    t1/2 was defined as the apparent terminal-phase disposition half life of INCB099280.

    Measured: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample

  16. Part 1: CLss/F of INCB099280 When Administered With Axitinib

    CLss/F was defined as the apparent oral dose clearance of INCB099280 at steady state.

    Measured: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample

  17. Part 1: Vz/F of INCB099280 When Administered With Axitinib

    Vz/F was defined as the apparent oral dose volume of distribution of INCB099280.

    Measured: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample

Timeline

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

  1. First posted18 Jul 2023
  2. Study start16 Apr 2024
  3. Primary completion6 Jun 2025
  4. Study completion6 Jun 2025

Why it stopped: This was a strategic business decision. There were no safety concerns contributing to this decision.

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
The study consists of 2 parts. In the Part 1 dose-escalation, participants will be enrolled in up to 6 dose levels of INCB099280 administered in combination with axitinib. In the Part 2 dose expansion, participants will be enrolled into 1 of 2 disease-specific cohorts at the dose(s) identified in Part 1.
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05949632
Sponsor's protocol ID
INCB99280-201
Other IDs
2023-510281-27-00, 2022-003663-13, 2023
Status last verified
May 2026
First submitted
10 Jul 2023
Last updated
4 Jun 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing INCB099280 and axitinib in people with Advanced Solid Tumors, run by Incyte Corporation at 6 sites in United Kingdom.

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 5 inclusion and 19 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: stopped early, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United Kingdom. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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: Number of Participants With Dose-limiting Toxicities (DLTs) (time frame: up to 3 weeks). 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 NCT05949632.

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 4 Jun 2026.

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