Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to learn if KQB365 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB365. The main questions it aims to answer are:
Participants will:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monotherapy Dose Escalation (Part 1) | Experimental | Drug: KQB365 - Intravenous KQB365 |
|
| Combo Therapy with Cetuximab Dose Escalation (Part 1) | Experimental | Drug: KQB365 - Intravenous KQB365 Drug: - Intravenous cetuximab |
|
| Monotherapy Dose Expansion - RP2D (Part 2) | Experimental | Drug: KQB365 - Intravenous KQB365 |
|
| Monotherapy Dose Expansion - RP2D-1 (Part 2) | Experimental | Drug: KQB365 - Intravenous KQB365 |
|
| Combo Therapy with Cetuximab Dose Expansion - RP2D (Part 2) | Experimental | Drug: KQB365 - Intravenous KQB365 Drug: - Intravenous cetuximab |
|
| Combo Therapy with Cetuximab Dose Expansion - RP2D-1 (Part 2) | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KQB365 | Drug | Intravenous KQB365 |
|
| 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 30 days after last dose of study treatment. | From enrollment to the end of treatment |
| Recommended Phase 2 Dose (RP2D) (Part 1) | Evaluate safety and assess number of patients with dose-limiting toxicity to determine the RP2D. | up to 35 months |
| Efficacy and Optimal Biologic Dose of study treatment, as measured by Objective Response Rate (ORR) (Part 2) | ORR 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 35 months |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration-time curve (AUC) | up to 35 months | |
| Maximum plasma concentration (Cmax) | up to 35 months | |
| Time to maximum plasma concentration (tmax) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kumquat Clinical Development | Contact | (858) 214-2700 | kumquatstudies@kumquatbio.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic, Phoenix | Recruiting | Phoenix | Arizona | 85054 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Drug: KQB365 - Intravenous KQB365 Drug: - Intravenous cetuximab |
|
| Combo Therapy with KQB198 Dose Escalation (Part 1) | Experimental | Drug: KQB365 - Intravenous KQB365 Drug: - Oral KQB198 |
|
| Cetuximab | Drug | Intravenous cetuximab |
|
| KQB198 | Drug | Oral KQB198 |
|
| up to 35 months |
| Overall survival (OS) | up to 35 months |
| Progression-free survival (PFS) | using RECIST v1.1 | up to 35 months |
| Overall response rate (ORR) | using RECIST v1.1 | up to 35 months |
| Duration of response (DOR) | using RECIST v1.1 | up to 35 months |
| Time to response (TTR) | using RECIST v1.1 | up to 35 months |
| Disease control rate (DCR) | using RECIST v1.1 | up to 35 months |
| Sarah Cannon Cancer Institute at HealthONE | Recruiting | Denver | Colorado | 80218 | United States |
|
| Mayo Clinic, Jacksonville | Recruiting | Jacksonville | Florida | 32224 | United States |
|
| Dana Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
|
| START Midwest | Recruiting | Grand Rapids | Michigan | 49546 | United States |
|
| Mayo Clinic, Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
|
| Cleveland Clinic, Taussig Cancer Institute | Recruiting | Cleveland | Ohio | 44195 | United States |
|
| OU Health Stephenson Cancer Center | Recruiting | Oklahoma City | Oklahoma | 73104 | United States |
|
| Sydney Kimmel Cancer Center | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
|
| NEXT Oncology | Recruiting | San Antonio | Texas | 78229 | United States |
|
| NEXT Virginia, LLC | Recruiting | Fairfax | Virginia | 22031 | United States |
|
| ID | Term |
|---|---|
| D015179 | Colorectal 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided