A Study to Evaluate INCB177054 in Participants With Select Advanced or Metastatic Solid Tumors

NCT06873789 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: INCB177054-101
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Solid Tumors; Advanced Solid Tumors; Metastatic Solid Tumors

Keywords

Solid Tumors; INCB177054

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Up to approximately 12 months and 45 days

Secondary Outcomes (3)

• Objective Response

  Up to approximately 12 months

• Duration of Response

  Up to approximately 12 months

• Disease Control

  Up to approximately 12 months

Study Arms (5)

Part 1a: Dose Escalation monotherapy

EXPERIMENTAL

INCB177054 at the protocol-defined dose strength based on cohort assignment.

Drug: INCB177054

Part 1b: Pharmacodynamic cohort

EXPERIMENTAL

INCB177054 at the protocol-defined dose strength based on cohort assignment.

Drug: INCB177054

Part 1c: Dose Expansion monotherapy

EXPERIMENTAL

INCB177054 at the protocol-defined dose strength based on cohort assignment.

Drug: INCB177054

Part 2a: Dose Escalation combination

EXPERIMENTAL

INCB177054 in combination with retifanlimab at the protocol-defined dose strength based on cohort assignment.

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.

Drug: INCB177054; Drug: Retifanlimab

Interventions

INCB177054 DRUG

INCB177054 will be administered at protocol defined dose.

Part 1a: Dose Escalation monotherapy; Part 1b: Pharmacodynamic cohort; Part 1c: Dose Expansion monotherapy; Part 2a: Dose Escalation combination; Part 2b: Dose Expansion combination

Retifanlimab DRUG

Retifanlimab will be administered at protocol defined dose.

Part 2a: Dose Escalation combination; Part 2b: Dose Expansion combination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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-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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (9)

The Angeles Clinic and Research Institute

Los Angeles, California, 90025, United States

Location

Valkyrie Clinical Trials

Panorama City, California, 91402, United States

Location

University of Florida Health Shands Hospital

Gainesville, Florida, 32610, United States

Location

Cancer and Hematology Centers of Western Michigan-Start Midwest

Grand Rapids, Michigan, 49546, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Carolina Bio Oncology

Huntersville, North Carolina, 28078, United States

Location

Providence Cancer Institute Franz Clinic

Portland, Oregon, 97213, United States

Location

Upmc Cancercenter

Pittsburgh, Pennsylvania, 15232, United States

Location

South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229, United States

Location

Related Links

• A study to evaluate INCB177054 in Participants With Select Advanced or Metastatic Solid Tumors

Study Officials

• Incyte Medical Monitor

  Incyte Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 13, 2025
• Study Start: June 30, 2025
• Primary Completion: May 8, 2026
• Study Completion: May 8, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)