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The goal of this clinical trial is to learn if KQB198 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB198. The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monotherapy Dose Escalation | Experimental |
| |
| Combo Therapy Dose Escalation | Experimental |
| |
| Combo Therapy Dose Expansion - RP2D | Experimental |
| |
| Combo Therapy Dose Expansion - RP2D-1 | Experimental |
| |
| Combo Therapy Dose Expansion OBD | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KQB198 | Drug | Oral KQB198 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities (Part 1) | Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of AEs, SAEs, and DLTs, from first dose of study treatment to 28 days after last dose of study treatment. | 28 Days |
| Recommended Phase 2 Dose (RP2D) (Part 1) | Evaluate safety and assess number of patients with dose-limiting toxicity to determine the RP2D. | up to 30 months |
| Efficacy and Optimal Biologic Dose of study treatment, as measured by Objective Response Rate (ORR) (Parts 2 and 3) | Objective response is the proportion of subjects that experience confirmed complete response (CR) or partial response (PR) based on RECIST v1.1 during the time period from 1st dose of study treatment until last dose. | up to 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration-time curve (AUC) | up to 30 months | |
| Maximum plasma concentration (Cmax) | up to 30 months | |
| Time to maximum plasma concentration (tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kumquat Clinical Development | Contact | (858) 214-2700 | kumquatstudies@kumquatbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sarah Cannon Research Institute at HealthONE | Recruiting | Denver | Colorado | 80218 | United States |
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| Osimertinib | Drug | Oral Osimertinib |
|
|
| Amivantamab | Drug | Subcutaneous administration |
|
| up to 30 months |
| Overall survival (OS) | up to 30 months |
| Progression-free survival (PFS) | up to 30 months |
| Overall response rate (ORR) | up to 30 months |
| Duration of response (DOR) | up to 30 months |
| Time to response (TTR) | up to 30 months |
| Sarah Cannon Research Institute at Florida Cancer Specialists - Lake Nona - | Recruiting | Orlando | Florida | 32827 | United States |
|
| Florida Cancer Specialists - Sarasota | Recruiting | Sarasota | Florida | 34232 | United States |
|
| Henry Ford Health System | Recruiting | Detroit | Michigan | 48202 | United States |
|
| David H. Koch Center for Cancer Center at Memorial Sloan Kettering Cancer Center | Recruiting | Long Island City | New York | 11101 | United States |
|
| The Lindner Center for Research and Education at The Christ Hospital | Recruiting | Cincinnati | Ohio | 45219 | United States |
|
| Sarah Cannon and HCA Research Institute | Recruiting | Nashville | Tennessee | 37203 | United States |
|
| MD Anderson Cancer Center | Withdrawn | Houston | Texas | 77030 | United States |
| New Experimental Therapeutics of San Antonio - NEXT Oncology | Recruiting | San Antonio | Texas | 78229 | United States |
|
| New Experimental Therapeutics of Virginia - NEXT Oncology | Recruiting | Fairfax | Virginia | 22031 | United States |
|
| Institut Paoli-Calmettes | Recruiting | Marseille | Bouches-du-Rhône | 13009 | France |
|
| Institut de Cancerologie de l'Ouest - site St-Herblain | Recruiting | Saint-Herblain | Loire-Atlantique | 44800 | France |
|
| CHU Bordeaux - Hopital Saint-Andre | Recruiting | Bordeaux | Nouvelle-Aquitane | 33000 | France |
| IUCT-Oncopole | Recruiting | Toulouse | Occitaine | 31059 | France |
|
| CHU de Nantes - Hopital Nord Laennec | Recruiting | Nantes | Pays de la Loire Region | 44000 | France |
|
| Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore | Recruiting | Rome | Lazio | 00168 | Italy |
|
| Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" | Recruiting | Naples | 80131 | Italy |
| National Cancer Center | Withdrawn | Goyang-si | Gyeonggi-do | 10408 | South Korea |
| Chonnam National University Hwasun Hospital | Withdrawn | Hwasun | Jeollanam-do | 58128 | South Korea |
| Severance Hospital, Yonsei University Health System | Withdrawn | Seoul | 03722 | South Korea |
| Seoul St. Mary's Hospital, The Catholic University of Korea | Withdrawn | Seoul | 06591 | South Korea |
| Hospital Universitari Quiron Dexeus Barcelona | Recruiting | Barcelona | Catalonia | 08028 | Spain |
|
| Hospital Universitario Vall d'Hebron | Recruiting | Barcelona | Catalonia | 08035 | Spain |
|
| New Experimental Therapeutics (NEXT) Oncology Barcelona | Recruiting | Barcelona | 08023 | Spain |
|
| South Texas Accelerated Research Therapeutics (START) Barcelona- HM Nou Delfos | Recruiting | Barcelona | 08023 | Spain |
|
| Hospital Universitario Ramon y Cajal | Recruiting | Madrid | 28034 | Spain |
|
| South Texas Accelerated Research Therapeutics (START) Madrid - CIOCC | Recruiting | Madrid | 28040 | Spain |
|
| New Experimental Therapeutics (NEXT) Oncology Madrid - Hospital Quironsalud Madrid | Recruiting | Madrid | 28223 | Spain |
|
| South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz | Recruiting | Madrid | Spain |
|
| Hospital Quirónsalud Málaga | Recruiting | Málaga | 29004 | Spain |
|
| Clinica Universidad de Navarra - Pamplona | Recruiting | Pamplona | 31008 | Spain |
|
| Chi-Mei Hospital - Liouying Branch | Withdrawn | Liuying | Tainan City | 73657 | Taiwan |
| National Taiwan University Hospital | Withdrawn | Taipei | Taipei City | 100225 | Taiwan |
| Taichung Veterans General Hospital | Withdrawn | Taichung | 40705 | Taiwan |
| Taipei Veterans General Hospital | Withdrawn | Taipei | 11217 | Taiwan |
| ID | Term |
|---|---|
| C000596361 | osimertinib |
| C000718215 | amivantamab |
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