Solid TumorsPhase 1/2NCT06873789
A Study to Evaluate INCB177054 in Participants With Select Advanced or Metastatic Solid Tumors
A Phase 1/2 study testing INCB177054 and Retifanlimab in people with Solid Tumors and Advanced Solid Tumors, run by Incyte Corporation at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Advanced Solid Tumors, Metastatic Solid Tumors
- What is being tested?
- INCB177054 and Retifanlimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 9 sitesUnited States
- Study dates
- 30 Jun 2025to 29 Jul 2026
- Phase
- Phase 1/2
- 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
- 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.
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- 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-positive (TPS ≥ 50%) NSCLC (Group 2), or locally recurrent or metastatic PD-L1-positive (CPS ≥ 1%) HNSCC (Group 3) (Primary tumors of the nasopharynx, sinonasal cavity, or salivary gland are excluded).
- Availability of a baseline archival tumor specimen or willingness to undergo a pretreatment biopsy to obtain.
- If HIV-positive, CD4+ count must be greater than or equal to 350 cells/μL, must have undetectable viral load per standard of care assay, and receiving antiretroviral therapy not containing a moderate or potent CYP3A4/CYP3A5 inhibitor or inducer for at least 4 weeks prior to study enrollment, and have not had any HIV-related opportunistic infection for at least 4 weeks prior to study enrollment.
- Willingness to avoid pregnancy or fathering children.
Who cannot join
- Known additional invasive malignancy within 1 year of the first dose of study drug.
- Known active CNS metastases and/or carcinomatous meningitis and/or leptomeningeal disease, or evidence of progression of previously treated CNS metastases.
- Prior treatment with a DGK inhibitor.
- Receipt of anticancer medications, investigational drugs, or other interventional clinical studies within 5 half-lives or 28 days before the first administration of study drug.
- History of organ transplant, including allogeneic stem cell transplantation.
- Radiation therapy administered within 28 days of the start of treatment.
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- Any residual toxic effects ≥ Grade 2 from prior therapy or surgery.
- Any immune-related toxicity during prior immune therapy for which permanent discontinuation or prolonged immunosuppression was recommended to manage.
- Laboratory values specified at screening.
- Significant concurrent, uncontrolled medical conditions, including but not limited to hepatic, gastrointestinal conditions, pulmonary, cardiovascular, and active autoimmune disease.
- Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment.
- Active HBV or HCV.
- Prohibited medication per protocol.
- Hypersensitivity to any component of study treatment or formulation components.
- Women who are pregnant or breastfeeding.
- Has received a live vaccine within 28 days of the planned start of study treatment.
- Any condition that would interfere with participation.
- Other protocol-defined Inclusion/Exclusion Criteria may apply.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Florida Health Shands Hospital
Gainesville, Florida, 32610
Cancer and Hematology Centers of Western Michigan-Start Midwest
Grand Rapids, Michigan, 49546
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Carolina Bio Oncology
Huntersville, North Carolina, 28078
The Angeles Clinic and Research Institute
Los Angeles, California, 90025
Valkyrie Clinical Trials
Panorama City, California, 91402
Upmc Cancercenter
Pittsburgh, Pennsylvania, 15232
Providence Cancer Institute Franz Clinic
Portland, Oregon, 97213
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
About this study
Official title: A Phase 1/2, Open-Label, Multicenter Study of INCB177054 in Participants With Select Advanced or Metastatic Solid Tumors
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.
- Conditions
- Solid Tumors, Advanced Solid Tumors, Metastatic Solid Tumors
- Being tested
- INCB177054, Retifanlimab
- Keywords
- Solid Tumors, INCB177054
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCB177054Drug
INCB177054 will be administered at protocol defined dose.
RetifanlimabDrug
Retifanlimab will be administered at protocol defined dose.
| Study group | Role | What they receive |
|---|---|---|
| Part 1a: Dose Escalation monotherapy | Experimental | INCB177054 at the protocol-defined dose strength based on cohort assignment. Receives: Drug: INCB177054 |
| Part 1b: Pharmacodynamic cohort | Experimental | INCB177054 at the protocol-defined dose strength based on cohort assignment. Receives: Drug: INCB177054 |
| Part 1c: Dose Expansion monotherapy | Experimental | INCB177054 at the protocol-defined dose strength based on cohort assignment. Receives: Drug: INCB177054 |
| Part 2a: Dose Escalation combination | Experimental | INCB177054 in combination with retifanlimab at the protocol-defined dose strength based on cohort assignment. Receives: Drug: INCB177054; Drug: Retifanlimab |
| Part 2b: Dose Expansion combination | Experimental | INCB177054 in combination with retifanlimab at the protocol-defined dose strength based on cohort assignment. Receives: Drug: INCB177054; Drug: Retifanlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Dose Limiting Toxicities (DLTs)
Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.
Measured: Up to 28 days
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Measured: Up to approximately 12 months and 45 days
Number of participants with TEAEs leading to study drug modifications
Number of participants with TEAEs leading to dose modification including interruptions, dose reductions, and discontinuation of study drug.
Measured: Up to approximately 12 months and 45 days
Secondary outcomes (3)
Objective Response
Defined as having a best overall response of Complete Response (CR) or Partial Response (PR) by investigator assessment (all participants) per RECIST v1.1.
Measured: Up to approximately 12 months
Duration of Response
Defined as the time from earliest date of disease response (CR or PR) until earliest date of disease progression as determined by the investigator by radiographic disease assessment per RECIST v1.1 or death due to any cause if occurring sooner than progression.
Measured: Up to approximately 12 months
Disease Control
Defined as having a best overall response of CR, PR, or Stable Disease (SD), by investigator assessment per RECIST v1.1.
Measured: Up to approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start30 Jun 2025
- Primary completion29 Jul 2026
- Study completion29 Jul 2026
Why it stopped: This was a strategic business decision. There were no safety concerns contributing to this decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Incyte Medical Monitor, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06873789
- Sponsor's protocol ID
- INCB177054-101
- Status last verified
- Aug 2026
- First submitted
- 11 Mar 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Open-Label, Multicenter Study of INCB177054 in Participants With Select Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06873789
- Acronym / sponsor ID
- INCB177054-101
- Conditions
- Solid Tumors, Advanced Solid Tumors, Metastatic Solid Tumors
- Keywords
- Solid Tumors, INCB177054
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This was a strategic business decision. There were no safety concerns contributing to this decision.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 29 Jul 2026 (actual)
- Study completion
- 29 Jul 2026 (actual)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1a: Dose Escalation monotherapy | Experimental | Drug: INCB177054INCB177054 at the protocol-defined dose strength based on cohort assignment. |
| Part 1b: Pharmacodynamic cohort | Experimental | Drug: INCB177054INCB177054 at the protocol-defined dose strength based on cohort assignment. |
| Part 1c: Dose Expansion monotherapy | Experimental | Drug: INCB177054INCB177054 at the protocol-defined dose strength based on cohort assignment. |
| Part 2a: Dose Escalation combination | Experimental | Drug: INCB177054, Drug: RetifanlimabINCB177054 in combination with retifanlimab at the protocol-defined dose strength based on cohort assignment. |
| Part 2b: Dose Expansion combination | Experimental | Drug: INCB177054, Drug: RetifanlimabINCB177054 in combination with retifanlimab at the protocol-defined dose strength based on cohort assignment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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 1b incurable locally recurrent or metastatic HNSCC:
Key exclusion criteria (18 listed)
- Known additional invasive malignancy within 1 year of the first dose of study drug.
- Known active CNS metastases and/or carcinomatous meningitis and/or leptomeningeal disease, or evidence of progression of previously treated CNS metastases.
- Prior treatment with a DGK inhibitor.
- Receipt of anticancer medications, investigational drugs, or other interventional clinical studies within 5 half-lives or 28 days before the first administration of study drug.
- History of organ transplant, including allogeneic stem cell transplantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INCB177054INCB177054 will be administered at protocol defined dose. | Drug | Part 1a: Dose Escalation monotherapy, Part 1b: Pharmacodynamic cohort, Part 1c: Dose Expansion monotherapy, Part 2a: Dose Escalation combination, Part 2b: Dose Expansion combination |
| RetifanlimabRetifanlimab will be administered at protocol defined dose. | Drug | Part 2a: Dose Escalation combination, Part 2b: Dose Expansion combination |
Primary outcome
Number of participants with Dose Limiting Toxicities (DLTs)
Time frame: Up to 28 days
Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to approximately 12 months and 45 days
Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Number of participants with TEAEs leading to study drug modifications
Time frame: Up to approximately 12 months and 45 days
Number of participants with TEAEs leading to dose modification including interruptions, dose reductions, and discontinuation of study drug.
3 secondary outcomes
Objective Response
Time frame: Up to approximately 12 months
Duration of Response
Time frame: Up to approximately 12 months
Disease Control
Time frame: Up to approximately 12 months
Results and safety
The study was stopped early (reason given: This was a strategic business decision. There were no safety concerns contributing to this decision.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- A study to evaluate INCB177054 in Participants With Select Advanced or Metastatic Solid TumorsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Incyte Medical Monitor study director
Incyte Corporation
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing INCB177054 and Retifanlimab in people with Solid Tumors and Advanced Solid Tumors, run by Incyte Corporation at 9 sites in United States.
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 14 inclusion and 18 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 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. 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?
The study was stopped early (reason given: This was a strategic business decision. There were no safety concerns contributing to this decision.). Results are not available in the source record.
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?
Number of participants with Dose Limiting Toxicities (DLTs) (time frame: Up to 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2026.