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Brief Title: INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors

A Phase 1, Open-Label, Multicenter Study of INCB106385 as Monotherapy or in Combination With Immunotherapy in Participants With Advanced Solid Tumors


  • Org Study ID: INCB 106385-102
  • Secondary ID: N/A
  • NTC ID: NCT04580485
  • Sponsor: Incyte Corporation


This is a multicenter, open-label, dose-escalation/dose-expansion Phase 1 clinical study to investigate the safety, tolerability, PK profile, pharmacodynamics, and preliminary clinical efficacy of INCB106385 when given as monotherapy or in combination with INCMGA00012 in participants with selected CD8 T-cell-positive advanced solid tumors including SCCHN, NSCLC, ovarian cancer, CRPC, TNBC, bladder cancer, and specified GI malignancies (defined as CRC, gastric/GEJ cancer, HCC, PDAC, or SCAC)

  • Overall Status
  • Start Date
    February 3, 2021
  • Phase
    Phase 1
  • Study Type


Primary Outcome 1 - Measure: Number of treatment-emergent adverse events (TEAE)

Primary Outcome 1 - Timeframe: Up to Approximately 28 months


  • Ovarian Cancer
  • Bladder Cancer
  • Non Small Cell Lung Cancer
  • Squamous Cell Carcinoma of Head and Neck
  • Triple Negative Breast Cancer
  • Castration Resistant Prostate Cancer
  • Colorectal Cancer
  • Gastric/ Gastroesophageal Junction
  • Hepatocellular Carcinoma
  • Pancreatic Ductal Adenocarcinoma
  • Squamous Carcinoma of the Anal Canal


Inclusion Criteria:
Ability to comprehend and willingness to sign an ICF.

- Willing and able to conform to and comply with all Protocol requirements.

- Histologically or cytologically confirmed advanced/metastatic SCCHN, NSCLC, ovarian cancer, TNBC, CRPC, bladder cancer, and specified GI malignancies (defined as CRC, gastric/GEJ cancer, HCC, PDAC, or SCAC) that progressed after treatment with available therapies (including anti PD-(L)1 therapy (if applicable).

- Willingness to undergo pre- and on-treatment tumor biopsy.

- Have CD8 T-cell-positive tumors.

- Presence of measurable disease according to RECIST v1.1.

- ECOG performance status 0 to 1.

- Life expectancy > 12 weeks.

- Willingness to avoid pregnancy or fathering children based.

- Acceptable laboratory parameters
Exclusion Criteria:
Clinically significant cardiac disease.

- Known or active CNS metastases and/or carcinomatous meningitis.

- Active or inactive autoimmune disease or syndrome that required systemic treatment in the past 2 years or receiving systemic therapy for an autoimmune or inflammatory disease..

- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (doses > 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study treatment.

- Known additional malignancy that is progressing or requires active treatment,or history of other malignancy within 2 years of the first dose of study treatment.

- Has not recovered to ≤ Grade 1 from toxic effects of prior therapy and/or complications from prior surgical intervention before starting study treatment.

- Evidence of interstitial lung disease, history of interstitial lung disease, or active, noninfectious pneumonitis.

- Immune-related toxicity during prior immune therapy for which permanent discontinuation of therapy is recommended, or any immune-related toxicity requiring intensive or prolonged immunosuppression to manage.

- Any prior chemotherapy, biological therapy, or targeted therapy to treat the participant's disease within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.

- Any prior radiation therapy within 28 days before the first dose of study treatment.

- Undergoing treatment with another investigational medication or having been treated with an investigational medication within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.

- Concomitant treatment with strong CYP3A4 inhibitors or inducers.

- Receipt of a live vaccine within 30 days of the first dose of study treatment.

- Infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week of the first dose of study treatment.

- Evidence of HBV or HCV infection or risk of reactivation.

- Known history of HIV (HIV 1/2 antibodies).

- History of organ transplant, including allogeneic stem-cell transplantation.

- Known hypersensitivity or severe reaction to any component of study drug(s) or formulation components.

- Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications.

- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study.

- Any condition that would, in the investigator's judgment, interfere with full participation in the study,pose a significant risk to the participant; or interfere with interpretation of study data

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No


Name: Ilona Rybicka, M.D

Role: Study Director

Affiliation: Incyte Corporation

Overall Contact

Name: Ilona Rybicka, M.D

Phone: 1.855.463.3463, +800 00027423

Email: medinfo@incyte.com, eumedinfo@incyte.com


Facility Status Contact