A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies

Part of paid clinical trials in Denver, Colorado.

Sponsor
Kumquat Biosciences Inc.
Study ID
NCT06507306
Phase
PHASE1
Status
Recruiting

Conditions

  • Solid Tumor, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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: * What is the safe dose of KQB198 by itself or in combination with other anti-cancer drugs? * Does KQB198 alone or in combination with other anti-cancer drugs decrease the size of the tumor? * What happens to KQB198 in the body? Participants will: * Take KQB198 daily, alone or in combination with another anti-cancer drug * Visit the clinic about 8 times in the first 8 weeks, and then once every 4 weeks after that

Key Dates

Start date
Jun 3, 2024
Status verified
Feb 2026
Primary completion
Jul 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 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

Primary Outcome Measure

Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities (Part 1) [ Time Frame: 28 Days ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Sarah Cannon Research Institute at HealthONEDenverColorado80218
Shelby Mosier-Murray
720-754-7862
Sarah Cannon Research Institute at Florida Cancer Specialists - Lake Nona -OrlandoFlorida32827
Ingrid Acker
904-380-2414
Florida Cancer Specialists - SarasotaSarasotaFlorida34232
Mallory Hawkins
941-377-9993
Henry Ford Health SystemDetroitMichigan48202
Jeevana Koneru
313-725-7857
David H. Koch Center for Cancer Center at Memorial Sloan Kettering Cancer CenterLong Island CityNew York11101
Navkaran Singh
The Lindner Center for Research and Education at The Christ HospitalCincinnatiOhio45219
Abby Reed
513-585-1140
Sarah Cannon and HCA Research InstituteNashvilleTennessee37203
Derrick Porter
619-982-4133
MD Anderson Cancer CenterHoustonTexas77030-
New Experimental Therapeutics of San Antonio - NEXT OncologySan AntonioTexas78229
Steven Alvarado
New Experimental Therapeutics of Virginia - NEXT OncologyFairfaxVirginia22031
Aber Lopez
703-565-2881

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