A Study to Investigate the Safety and Efficacy of KQB168 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Kumquat Biosciences Inc.
Study ID
NCT06994806
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Solid Tumor Malignancies

Eligibility Criteria

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

Interventions

  • KQB168 — DRUG
    Oral KQB168
  • Pembrolizumab — DRUG
    Intravenous pembrolizumab

Study Details

The goal of this clinical trial is to learn if KQB168 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB168. The main questions it aims to answer are: * What is the safe dose of KQB168 by itself or in combination with pembrolizumab? * Does KQB168 alone or in combination with pembrolizumab decrease the size of the tumor? * What happens to KQB168 in the body? Participants will: * Take KQB168 daily, alone or in combination with pembrolizumab * Visit the clinic about 8 times in the first 8 weeks, and then once every 3 weeks after that

Key Dates

Start date
Jun 24, 2025
Status verified
Feb 2026
Primary completion
Nov 30, 2027
Completion
May 31, 2028

Study Design

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

Arms

  • Experimental: Monotherapy Dose Escalation
    Drug: KQB168 - Oral KQB168
  • Experimental: Combo Therapy Dose Escalation
    Drug: KQB168 - Oral KQB168 Drug: pembrolizumab - Intravenous pembrolizumab

Primary Outcome Measure

Number of patients who experience treatment-emergent adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) [ Time Frame: up to 36 months ]

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
Mayo Clinic - PhoenixPhoenixArizona85054
Robby Bennett
[email protected]
480-342-6641
USC Norris Comprehensive Cancer CenterLos AngelesCalifornia90033
Stephanie Kim
[email protected]
323-865-0240
Sarah Cannon Cancer Institute at HealthONEDenverColorado80218
Brandon Johnson
[email protected]
720-754-2610
Yale Cancer Center- New HavenNew HavenConnecticut06520
Priscilla Steve
[email protected]
203-464-5564
Mayo Clinic - JacksonvilleJacksonvilleFlorida32224
Kendal Klein
[email protected]
904-953-3545
Florida Cancer Specialists - SarasotaSarasotaFlorida34232
Sarah Gwirtz
[email protected]
941-377-9993
University of IowaIowa CityIowa52242
Jennifer Adams
[email protected]
319-467-6774
Mayo Clinic - RochesterRochesterMinnesota55905
Siobhan Chantigian
[email protected]
507-738-7036
Cleveland ClinicClevelandOhio44195
Heather Keaney
[email protected]
216-444-3409
NEXT AustinAustinTexas78758
Heather Watson
[email protected]
737-610-5202
Mary Crowley Cancer Research CentersDallasTexas75230
Sangavi Manalan
[email protected]
972-566-3014
NEXT HustonHoustonTexas77054
Emma Morales
[email protected]
(832) 384-7912
UT MD Anderson Cancer Center - HoustonHoustonTexas77030
Anupama Madhyannapu
[email protected]
346-722-9365
NEXT OncologySan AntonioTexas78229
Jordan Georg
[email protected]
(210) 580-9521
NEXT VirginiaFairfaxVirginia22031
Referral Coordinator
[email protected]
(703) 783-4518

Find similar trials in Phoenix, AZ

By research site
Mayo Clinic - Phoenix· Phoenix, AZUSC Norris Comprehensive Cancer Center· Los Angeles, CASarah Cannon Cancer Institute at HealthONE· Denver, COYale Cancer Center- New Haven· New Haven, CTMayo Clinic - Jacksonville· Jacksonville, FLFlorida Cancer Specialists - Sarasota· Sarasota, FL

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