A Study to Evaluate INCB177054 in Participants With Select Advanced or Metastatic Solid Tumors (NCT06873789) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A Study to Evaluate INCB177054 in Participants With Select Advanced or Metastatic Solid Tumors
United States9 participantsStarted 2025-06-30
Plain-language summary
This study will be conducted to evaluate INCB177054 given as monotherapy or in combination with retifanlimab in participants with select advanced or metastatic solid Tumors.
Who can participate
Age range
18 Years
Sex
ALL
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:
* Anticipated life expectancy greater than 12 weeks.
* ECOG performance status score of 0 or 1.
* Measurable disease per RECIST v1.1 on CT or MRI.
* Part 1a and 2a (dose escalation) and Part 1c (dose expansion): participants who have a confirmed tissue diagnosis of a solid malignant tumor that is progressing and not amenable to curative surgery or other curative treatment modalities.
* Part 1a (monotherapy): Participants must have had disease progression on/after prior treatment and have been considered for all standard available therapies (have disease progression on all available standard treatment options or are intolerant or ineligible to them or has refused available options approved in the region).
* Part 2a (combination): participants with advanced malignant tumors for whom immunotherapy is an appropriate treatment option.
* Part 1b incurable locally recurrent or metastatic HNSCC:
* Tissue diagnosis of HNSCC.
* Locally recurrent disease must not be amenable to therapy (surgery and/or radiation therapy with or without chemotherapy) with curative intent. Participants who refuse curative salvage surgery for locally recurrent disease are ineligible.
* Eligible primary tumor locations include oral cavity, oropharynx, hypopharynx, or larynx. Primary tumors of the nasopharynx, sinonasal cavity, or salivary gland are excluded.
* Part 2b combination dose-expansion cohorts in locally advanced or metastatic SCAC (Group 1), metastatic PD-L1-positiv…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
1
Number of participants with Dose Limiting Toxicities (DLTs)
Timeframe: Up to 28 days
2
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Timeframe: Up to approximately 12 months and 45 days
3
Number of participants with TEAEs leading to study drug modifications
Timeframe: Up to approximately 12 months and 45 days