INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors

• Status: Recruiting
• Trial end date: 2023-07-29
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation

Criteria

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 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