A Study to Investigate the Safety and Efficacy of KQB365 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
NCT06720987
Phase
PHASE1
Status
Recruiting
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Conditions

  • CRC (Colorectal Cancer)
  • KRAS G12C Mutation
  • KRAS G12S Mutation
  • Solid Tumor Malignancies

Eligibility Criteria

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

Interventions

  • KQB365 — DRUG
    Intravenous KQB365
  • Cetuximab — DRUG
    Intravenous cetuximab
  • KQB198 — DRUG
    Oral KQB198

Study Details

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: * What is the safe dose of KQB365 by itself, in combination with cetuximab, or in combination with KQB198? * Does KQB365 alone, in combination with cetuximab, or in combination with KQB198 decrease the size of the tumor? * What happens to KQB365 in the body? Participants will: * Receive KQB365 infusion weekly alone, in combination with cetuximab, or in combination with oral KQB198. * Visit the clinic about 9 times in the first 6 weeks, and then once every week after that.

Key Dates

Start date
Feb 4, 2025
Status verified
Apr 2026
Primary completion
Jun 30, 2029
Completion
Jun 30, 2030

Study Design

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

Arms

  • Experimental: Monotherapy Dose Escalation (Part 1)
    Drug: KQB365 \- Intravenous KQB365
  • Experimental: Combo Therapy with Cetuximab Dose Escalation (Part 1)
    Drug: KQB365 - Intravenous KQB365 Drug: \- Intravenous cetuximab
  • Experimental: Monotherapy Dose Expansion - RP2D (Part 2)
    Drug: KQB365 \- Intravenous KQB365
  • Experimental: Monotherapy Dose Expansion - RP2D-1 (Part 2)
    Drug: KQB365 \- Intravenous KQB365
  • Experimental: Combo Therapy with Cetuximab Dose Expansion - RP2D (Part 2)
    Drug: KQB365 - Intravenous KQB365 Drug: \- Intravenous cetuximab
  • Experimental: Combo Therapy with Cetuximab Dose Expansion - RP2D-1 (Part 2)
    Drug: KQB365 - Intravenous KQB365 Drug: \- Intravenous cetuximab
  • Experimental: Combo Therapy with KQB198 Dose Escalation (Part 1)
    Drug: KQB365 - Intravenous KQB365 Drug: \- Oral KQB198

Primary Outcome Measure

Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities (Part 1) [ Time Frame: From enrollment to the end of treatment ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
Mayo Clinic, PhoenixPhoenixArizona85054
855-776-0015
Sarah Cannon Cancer Institute at HealthONEDenverColorado80218
[email protected]
720-754-2610
Mayo Clinic, JacksonvilleJacksonvilleFlorida32224
855-776-0015
Dana Farber Cancer InstituteBostonMassachusetts02215
Danielle Lindquist
[email protected]
857-215-2351
START MidwestGrand RapidsMichigan49546
Ashley Spagnuolo
[email protected]
616-954-5552
Mayo Clinic, RochesterRochesterMinnesota55905
855-776-0015
Cleveland Clinic, Taussig Cancer InstituteClevelandOhio44195
[email protected]
216-444-7923
OU Health Stephenson Cancer CenterOklahoma CityOklahoma73104
Shamika Wright
Sydney Kimmel Cancer CenterPhiladelphiaPennsylvania19107
Dennis Stone
[email protected]
215-955-6000
NEXT OncologySan AntonioTexas78229
Jordan Georg
[email protected]
210-580-9521
NEXT Virginia, LLCFairfaxVirginia22031
Blake Patterson
[email protected]
703-783-4505

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By research site
Mayo Clinic, Phoenix· Phoenix, AZSarah Cannon Cancer Institute at HealthONE· Denver, COMayo Clinic, Jacksonville· Jacksonville, FLDana Farber Cancer Institute· Boston, MASTART Midwest· Grand Rapids, MIMayo Clinic, Rochester· Rochester, MN

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