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| Name | Class |
|---|---|
| Worldwide Clinical Trials | OTHER |
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The goal of this study is to learn if KQB368 works to treat advanced solid malignancies in adults. The study will also learn about the safety of KQB368. The main questions the study aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monotherapy Dose Escalation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KQB368 | Drug | Oral KQB368 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Objective | Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities. 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 30 days after last dose of study treatment. | Up to 44 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Evaluate efficacy of study treatment, as measured by Objective Response Rate (ORR) using Response Evaluation Criteria (RECISTv1.1). 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 first dose of study treatment until last dose. | Up to 44 months |
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kumquat Clinical Development Telephone | Contact | 858.214.2700 | kumquatstudies@kumquatbio.com |
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| Overall survival (OS) | Evaluate efficacy of study treatment characterized by OS. Overall survival is defined as the time from start of treatment to death. | Up to 44 months |
| Duration of response (DOR) | Duration of response is defined as the time from date of the first documentation of objective tumor response (CR or PR) based on RECIST v1.1 to the first documentation of either PD or death due to any cause, whichever occurs first. | Up to 44 months |
| Time to response (TTR) | Time to response is defined as time from first dose of study treatment to date of first documentation of objective tumor response (CR or PR) based on RECIST v1.1. | Up to 44 months |
| Disease control rate (DCR) | Disease control rate is the proportion of subjects that experience confirmed complete response (CR), partial response (PR), or stable disease based on RECIST v1.1 during the time period from first dose of study treatment until last dose. | Up to 44 months |
| Progression-free survival (PFS) | Progression-free survival is defined as the time from enrollment to the date of Progressive Disease (PD) based on RECIST v1.1 or death due to any cause, whichever occurs first. | Up to 44 months |
| Area under the concentration-time curve (AUC) | Up to 44 months |
| Maximum plasma concentration (Cmax) | Up to 44 months |
| Time to maximum plasma concentration (tmax) | Up to 44 months |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D014594 | Uterine Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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