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NCT05949632 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1, PHASE2
Status at capture
TERMINATED
Registry last update
2026-06-04

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

Part 2: Objective Response

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outcome · POSTED

Part 2: Number of Participants With Any TEAE

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outcome · POSTED

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

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outcome · POSTED

Part 1: Objective Response

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outcome · POSTED

Part 1: Disease Control

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outcome · POSTED

Part 1: Duration of Response (DOR)

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outcome · POSTED

Part 1: INCB099280 and Axitinib Plasma Concentrations

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outcome · POSTED

Part 1: Cmax of INCB099280 When Administered With Axitinib

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outcome · POSTED

Part 1: Tmax of INCB099280 When Administered With Axitinib

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

Part 1: Cavg of INCB099280 When Administered With Axitinib

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outcome · POSTED

Part 1: Ctau of INCB099280 When Administered With Axitinib

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.
healthy Volunteers
false
minimum Age
18 Years
sex
FEMALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Up 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.
    intervention Names
    1. Drug: INCB099280
    2. Drug: axitinib
    label
    Part 1: Dose Escalation
    type
    EXPERIMENTAL
  2. description
    On 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.
    intervention Names
    1. Drug: INCB099280
    2. Drug: axitinib
    label
    Part 2: Dose Expansion
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Part 1: Dose Escalation
    2. Part 2: Dose Expansion
    description
    Administered as specified in the treatment arm description
    name
    INCB099280
    type
    DRUG
  2. arm Group Labels
    1. Part 1: Dose Escalation
    2. Part 2: Dose Expansion
    description
    Administered as specified in the treatment arm description
    name
    axitinib
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
intervention 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 Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
5
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)
    time Frame
    up to 3 weeks
  2. description
    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.
    measure
    Part 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
    time Frame
    up to approximately 1 year
  3. description
    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.
    measure
    Part 1: Number of Participants With TEAEs Leading to a Dosing Modification (Treatment Interruption, Dose Reduction, and Permanent Discontinuation of Either Study Drug)
    time Frame
    up to approximately 1 year
  4. description
    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.
    measure
    Part 2: Objective Response
    time Frame
    up to 2 years
secondary Outcomes
  1. description
    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.
    measure
    Part 2: Number of Participants With Any TEAE
    time Frame
    up to 2 years
  2. description
    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.
    measure
    Part 2: Number of Participants With TEAEs Leading to a Dosing Modification (Treatment Interruption, Dose Reduction, and Permanent Discontinuation of Either Study Drug)
    time Frame
    up to 2 years
  3. description
    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.
    measure
    Part 1: Objective Response
    time Frame
    up to 335 days
  4. description
    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.
    measure
    Part 1: Disease Control
    time Frame
    up to 335 days
  5. description
    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.
    measure
    Part 1: Duration of Response (DOR)
    time Frame
    up to 335 days
  6. description
    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.
    measure
    Part 1: INCB099280 and Axitinib Plasma Concentrations
    time Frame
    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. description
    Cmax was defined as the maximum observed concentration of INCB099280.
    measure
    Part 1: Cmax of INCB099280 When Administered With Axitinib
    time Frame
    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. description
    tmax was defined as the time to the maximum concentration of INCB099280.
    measure
    Part 1: Tmax of INCB099280 When Administered With Axitinib
    time Frame
    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. description
    AUC0-4h was defined as area under the steady-state plasma or serum concentration-time curve from 0 to 4 hours.
    measure
    Part 1: AUC0-4h of INCB099280 When Administered With Axitinib
    time Frame
    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. description
    Cmax,ss was defined as the maximum observed concentration at steady state.
    measure
    Part 1: Cmax,ss of INCB099280 When Administered With Axitinib
    time Frame
    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. description
    tmax,ss was defined as the time to the maximum concentration of INCB099280 at steady state.
    measure
    Part 1: Tmax,ss of INCB099280 When Administered With Axitinib
    time Frame
    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. description
    AUC0-12h was defined as the area under the steady-state plasma or serum concentration-time curve from 0 to 12 hours.
    measure
    Part 1: AUC0-12h of INCB099280 When Administered With Axitinib
    time Frame
    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
Full study description
brief 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.
Source references
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice