A Study to Investigate the Safety and Efficacy of KQB365 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies
NCT ID: NCT06720987
Last Updated: 2025-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
128 participants
INTERVENTIONAL
2025-02-04
2030-06-30
Brief Summary
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* What is the safe dose of KQB365 by itself or in combination with cetuximab?
* Does KQB365 alone or in combination with cetuximab decrease the size of the tumor?
* What happens to KQB365 in the body?
Participants will:
* Receive KQB365 infusion weekly alone or in combination with cetuximab
* Visit the clinic about 9 times in the first 6 weeks, and then once every week after that.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Monotherapy Dose Escalation
Drug: KQB365
\- Intravenous KQB365
KQB365
Intravenous KQB365
Combo Therapy Dose Escalation
Drug: KQB365 - Intravenous KQB365
Drug:
\- Intravenous cetuximab
KQB365
Intravenous KQB365
Cetuximab
Intravenous cetuximab
Monotherapy Dose Expansion - RP2D
Drug: KQB365
\- Intravenous KQB365
KQB365
Intravenous KQB365
Monotherapy Dose Expansion - RP2D-1
Drug: KQB365
\- Intravenous KQB365
KQB365
Intravenous KQB365
Combo Therapy Dose Expansion - RP2D
Drug: KQB365 - Intravenous KQB365
Drug:
\- Intravenous cetuximab
KQB365
Intravenous KQB365
Cetuximab
Intravenous cetuximab
Combo Therapy Dose Expansion - RP2D-1
Drug: KQB365 - Intravenous KQB365
Drug:
\- Intravenous cetuximab
KQB365
Intravenous KQB365
Cetuximab
Intravenous cetuximab
Interventions
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KQB365
Intravenous KQB365
Cetuximab
Intravenous cetuximab
Eligibility Criteria
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Inclusion Criteria
* PART 1 (combo therapy) \& PART 2: Histologically confirmed diagnosis of adenocarcinoma of the colon or rectum with either a KRAS G12C or KRAS G12S mutation.
* Unresectable or metastatic disease
* No available treatment with curative intent
* Adequate organ function
* Measurable disease per RECIST v1.1
Exclusion Criteria
* Cardiac abnormalities
* Active interstitial lung disease
18 Years
ALL
No
Sponsors
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Kumquat Biosciences Inc.
INDUSTRY
Responsible Party
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Locations
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Mayo Clinic, Phoenix
Phoenix, Arizona, United States
Sarah Cannon Cancer Institute at HealthONE
Denver, Colorado, United States
Mayo Clinic, Jacksonville
Jacksonville, Florida, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
START Midwest
Grand Rapids, Michigan, United States
Mayo Clinic, Rochester
Rochester, Minnesota, United States
Cleveland Clinic, Taussig Cancer Institute
Cleveland, Ohio, United States
NEXT Oncology
San Antonio, Texas, United States
NEXT Virginia, LLC
Fairfax, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Other Identifiers
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KQB365-101
Identifier Type: -
Identifier Source: org_study_id
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