Solid Tumors Advanced Solid Tumors Metastatic Solid Tumors
Conditions
Interventions
Experimental: Part 1a - Dose Escalation Monotherapy
INCA33890 will be administered at the protocol-defined dose based on cohort assignment.
Experimental: Part 1b-Dose Expansion Monotherapy
INCA33890
Sponsors
Ono Shintaro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. >=18 years old 2. Histologically or cytologically confirmed advanced or metastatic malignancies as defined in the protocol. 3. Part 1: Participants must have experienced disease progression after treatment with, be intolerant to, or be ineligible for, or refused available therapies, including anti-PD-(L)1 or anti-CTLA4 therapy if applicable, that are known to confer clinical benefit. Part 2: depending on cohort, participants may have received or not prior treatment for the malignancy under study. 4. ECOG performance status score of 0 or 1. 5. Willingness to undergo pre- and on-treatment tumor biopsy (core or excisional). Biopsies are mandatory depending on the cohorts. 6. Presence of measurable disease according to RECIST v1.1
Exclusion criteria
Exclusion criteria: 1. Any known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years. 2. Not recovered to 10 mg/day of prednisone or equivalent). 9. Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment. 10. Participants that have been initiated on or had modifications in anticoagulation therapies within the last 3 months prior to first dose of treatment. 11. Significant concurrent, uncontrolled medical condition, eg: Cardiovascular: Participants with known vasculitis, aneurisms, and other vascular malformations of clinical significance or history of myocarditis. 12. Participants with adequate laboratory values within the protocol defined ranges. Other protocol-defined Inclusion/Exclusion Criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Dose Limiting Toxicities (DLTs) [Time Frame: Up to 28 days] 2. Treatment Emerging Adverse Events (TEAEs) [Time Frame: Up to 2 years] 3. TEAEs leading to dose modification or discontinuation [Time Frame: Up to 2 years] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Objective response Rate [Time Frame: 2 years] 2. Disease Control Rate [Time Frame: 2 years] 3. Duration of Response [Time Frame: 2 years] 4. Pharmacokinetics Parameter : Cmax of INCA33890 [Time Frame: Pre dose - Day 1 of Cycle 1(C1D1)- 28 (each cycle is 28 days), Day 15 of Cycle 1-3; 10min and 4hrs Post dose(PD) - C1D1,C1D4, 24hrs PD C1D2, any time PD Day 4, 8, 22, of Cycle 1, and any time during 30 day Follow Up] 5. Pharmacokinetics Parameter : Tmax of INCA33890 [Time Frame: Pre dose - Day 1 of Cycle 1(C1D1)- 28 (each cycle is 28 days), Day 15 of Cycle 1-3; 10min and 4hrs Post dose(PD) - C1D1,C1D4, 24hrs PD C1D2, any time PD Day 4, 8, 22, of Cycle 1, and any time during 30 day Follow Up] 6. Pharmacokinetics Parameter : Cmin of INCA33890 [Time Frame: Pre dose - Day 1 of Cycle 1(C1D1)- 28 (each cycle is 28 days), Day 15 of Cycle 1-3; 10min and 4hrs Post dose(PD) - C1D1,C1D4, 24hrs PD C1D2, any time PD Day 4, 8, 22, of Cycle 1, and any time during 30 day Follow Up] 7. Pharmacokinetics Parameter : AUC(0-t) of INCA33890 [Time Frame: Pre dose - Day 1 of Cycle 1(C1D1)- 28 (each cycle is 28 days), Day 15 of Cycle 1-3; 10min and 4hrs Post dose(PD) - C1D1,C1D4, 24hrs PD C1D2, any time PD Day 4, 8, 22, of Cycle 1, and any time during 30 day Follow Up] 8. Pharmacokinetics Parameter : AUC 0-inf of INCA33890 [Time Frame: Pre dose - Day 1 of Cycle 1(C1D1)- 28 (each cycle is 28 days), Day 15 of Cycle 1-3; 10min and 4hrs Post dose(PD) - C1D1,C1D4, 24hrs PD C1D2, any time PD Day 4, 8, 22, of Cycle 1, and any time during 30 day Follow Up] 9. Pharmacokinetics Parameter : CL of INCA33890 [Time Frame: Pre dose - Day 1 of Cycle 1(C1D1)- 28 (each cycle is 28 days), Day 15 of Cycle 1-3; 10min and 4hrs Post dose(PD) - C1D1,C1D4, 24hrs PD C1D2, any time PD Day 4, 8, 22, of Cycle 1, and any time during 30 day Follow Up] 10. Pharmacokinetics Parameter : Vz of INCA33890 [Time Frame: Pre dose - Day 1 of Cycle 1(C1D1)- 28 (each cycle is 28 days), Day 15 of Cycle 1-3; 10min and | — |
Countries
Denmark, France, Italy, Japan, Spain, Switzerland, United Kingdom, United States
Contacts
Public ContactMedical Information Center
Incyte Biosciences Japan G.K.
Outcome results
None listed