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BRIEF TITLE: INCB106385 as Monotherapy or in Combination With Immunotherapy in Participants With 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:
  • NCT ID: NCT04580485
  • NCT Alias:
  • Sponsor: Incyte Corporation - Industry
  • Source: Incyte Corporation

Brief Summary

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, or bladder cancer

Overal Status Start Date Phase Study Type
Recruiting February 10, 2021 Phase 1 Interventional

Primary Outcomes:

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

Primary Outcome 1 - Time Frame: 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


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 or bladder cancer 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

- 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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Sven Gogov, M.D

Role: Study Director

Affiliation: Incyte Corporation

Overall Contact

Name: Incyte Corporation Call Center (US)

Phone: 1.855.463.3463



Facility Status Contact
Md Anderson Cancer Center
Houston, Texas 77030
United States