TerminatedPhase 1/2

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

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

United Kingdom5 participantsStarted 2024-04-16

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial was terminated before completing — do you know why it was stopped early, and does that affect whether the INCB099280 plus axitinib combination is still being considered a viable treatment approach for my type of cancer?
2Since this was a Phase 1/2 study focused on measuring side effects and safe dosing, what does the early termination mean for how much we actually know about whether this drug combination is safe or effective?
3Are there any other active trials or standard treatment options involving axitinib or similar checkpoint-related approaches that might be worth considering instead, given that this study is no longer enrolling?
4Given that one of the main things this trial was tracking was how often participants had to stop or reduce their doses due to side effects, what does that tell us about the tolerability profile of combining these two drugs?
5Could the data collected before this trial was terminated give my care team any useful information about how INCB099280 combined with axitinib might perform, or is there too little data to draw any conclusions?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: up to 3 weeks

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

Timeframe: up to approximately 1 year

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

Timeframe: up to approximately 1 year

Part 2: Objective Response

Timeframe: up to 2 years

Trial details

NCT IDNCT05949632

SponsorIncyte Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-06

Results submitted2026-04-07

View on ClinicalTrials.gov More Advanced Solid Tumors trials

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: up to 3 weeks

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

Timeframe: up to approximately 1 year

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

Timeframe: up to approximately 1 year

Part 2: Objective Response

Timeframe: up to 2 years