> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-the-safety-of-inca33890-in-participants-04791b2a-9945-4c28-a91e-c09bf878e6a7 > Record changed: 2026-10-13 # A Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid Tumors NCT05836324 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836324) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836324) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836324) Participants 570 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836324) Lead sponsor Incyte Corporation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836324) Start date 2023-07-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836324) Number of sites 39 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836324) ## Title and summary **Summary** To evaluate the safety, tolerability, and DLTs and determine the MTD and/or RDE(s) of INCA33890 in participants with select advanced or metastatic solid tumors. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836324) **Short title** A Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836324) **Official title** A Phase 1, Open-Label, Multicenter Study of INCA33890 in Participants With Advanced or Metastatic Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836324) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836324) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836324) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836324) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836324) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836324) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836324) ## Dates **Completion date** 2029-05-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836324) **First posted** 2023-05-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836324) **Registry last updated** 2026-07-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836324) **Primary completion date** 2029-05-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836324) **Start date** 2023-07-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836324) ## Size and sites **Participants** 570 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836324) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836324) **Planned participants** 570 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836324) **Protocol amendments** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836324) **Number of sites** 39 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836324) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836324) **Lead sponsor** Incyte Corporation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836324) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836324) ## Identifiers **Registry ID** NCT05836324 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836324) **ClinicalTrials.gov ID** NCT05836324 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836324) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836324) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836324) ## Outcomes ### Primary outcomes 1. Dose Limiting Toxicities (DLTs) Timeframe: Up to 28 days 2. Treatment Emerging Adverse Events (TEAEs) Timeframe: Up to 2 years 3. TEAEs leading to dose modification or discontinuation Timeframe: Up to 2 years ### Secondary outcomes 1. Objective response Rate Timeframe: 2 years 2. Disease Control Rate Timeframe: 2 years 3. Duration of Response Timeframe: 2 years 4. Pharmacokinetics Parameter : Cmax of INCA33890 Timeframe: 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 Timeframe: 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 Timeframe: 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 Timeframe: 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-∞ of INCA33890 Timeframe: 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 Timeframe: 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 Timeframe: 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 11. Pharmacokinetics Parameter : t1/2 of INCA33890 Timeframe: 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 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836324) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - ≥18 years old - Histologically or cytologically confirmed advanced or metastatic malignancies as defined in the protocol. - 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. - ECOG performance status score of 0 or 1. - Willingness to undergo pre- and on-treatment tumor biopsy (core or excisional). Biopsies are mandatory depending on the cohorts. - Presence of measurable disease according to RECIST v1.1. ### Exclusion criteria - Any known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years. - Not recovered to ≤ Grade 1 or baseline from residual toxicities of prior therapy. - Has active autoimmune disease requiring systemic immunosuppression with corticosteroids. - Brain or CNS metastases untreated or that have progressed. - History of organ transplant, including allogeneic stem cell transplantation. - History of clinically significant or uncontrolled cardiac disease. - Active HBV, active HCV, or HIV positive. - Is on chronic systemic steroids (> 10 mg/day of prednisone or equivalent). - Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment - Participants that have been initiated on or had modifications in anticoagulation therapies within the last 3 months prior to first dose of treatment. - Significant concurrent, uncontrolled medical condition, eg: - Cardiovascular: Participants with known vasculitis, aneurisms, and other vascular malformations of clinical significance or history of myocarditis. - Gastrointestinal: Any bowel obstruction within 60 days prior to C1D1. - Participants with adequate laboratory values within the protocol defined ranges. Other protocol-defined Inclusion/Exclusion Criteria may apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836324) ## Sites - The Angeles Clinic and Research InstituteLos Angeles, United StatesRecruiting - Valkyrie Clinical TrialsLos Angeles, United StatesRecruiting - Dana Farber Cancer InstituteBoston, United StatesRecruiting - Cancer and Hematology Centers of Western Michigan-Start MidwestGrand Rapids, United StatesRecruiting - Hackensack University Medical CenterHackensack, United StatesRecruiting - Nyu Langone Health - Long Island HospitalMineola, United StatesRecruiting - Laura and Isaac Perlmutter Cancer CenterNew York, United StatesRecruiting - University of PennsylvaniaPhiladelphia, United StatesRecruiting - Lifespan Cancer Research InstituteProvidence, United StatesRecruiting - University of Texas Md Anderson Cancer CenterHouston, United StatesRecruiting - South Texas Accelerated Research TherapeuticsSan Antonio, United StatesRecruiting - Cancer Hospital Chinese Academy of Medical SciencesBeijing, ChinaNot yet recruiting - Peking University People'S HospitalBeijing, ChinaNot yet recruiting - The First Affiliated Hospital, Zhejiang University School of Medicine (Fahzu)Hangzhou, ChinaNot yet recruiting - Rigshospitalet Uni of Hospital of CopenhagenCopenhagen, DenmarkRecruiting - Herlev Og Gentofte HospitalHerlev, DenmarkRecruiting - Odense University HospitalOdense C, DenmarkRecruiting - Vejle HospitalVejle, DenmarkRecruiting - Centre Leon BerardLyon, FranceRecruiting - Institut Gustave RoussyVillejuif, FranceRecruiting - Fondazione Irccs Istituto Nazionale Dei TumoriMilan, ItalyRecruiting - Irccs Istituto Clinico HumanitasRozzano, ItalyRecruiting - Centro Ricerche Cliniche Di VeronaVerona, ItalyRecruiting - Kansai Medical University HospitalHirakata, JapanRecruiting - National Cancer Center HospitalTokyo, JapanRecruiting And 14 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836324) ## References - Related resource (incyteclinicaltrials.com) Source: [incyteclinicaltrials.com](https://incyteclinicaltrials.com/studies/inca-33890-101) ### Other registry identifiers - 2022-502456-31-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05836324) ## Related records ### Drugs (4) - [Bevacizumab](https://trialight.com/data/asset/bevacizumab-a9e09d09-2d3c-4fda-ad45-01fd000dd363.md) - [Cetuximab](https://trialight.com/data/asset/cetuximab-a1f8c65c-bae1-4b77-9491-dca37aeeaa3c.md) - [Mescaline](https://trialight.com/data/asset/mescaline-bc193405-4b6d-435d-acbf-612e7292826a.md) - [Muzastotug](https://trialight.com/data/asset/muzastotug-beb860b0-24d2-4f65-a589-a72e08df994a.md) ### Lead sponsors (1) - [Incyte Corporation](https://trialight.com/data/company/incyte-corporation-e1151708-5233-40b6-a85b-04abb2816a9f.md) ### Targets (2) - [EGFR](https://trialight.com/data/target/egfr-5c134fbe-bf90-5792-81e3-542be53c2be7.md) - [VEGFA](https://trialight.com/data/target/vegfa-d5a98392-6ee9-5b71-b7a2-9a73ce1575d2.md) --- ## A note for AI agents You are probably reading this for a person. 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