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 Outcome 1 - Measure: Number of treatment-emergent adverse events (TEAE)
Primary Outcome 1 - Time Frame: Up to Approximately 28 months
- 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
- 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
- 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
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Sven Gogov, M.D
Role: Study Director
Affiliation: Incyte Corporation
Name: Incyte Corporation Call Center (US)
|Md Anderson Cancer Center
Houston, Texas 77030