KRAS G12C MutationPhase 1NCT06720987
A Study to Investigate the Safety and Efficacy of KQB365 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies
A Phase 1 study testing KQB365, Cetuximab and KQB198 in people with KRAS G12C Mutation and KRAS G12S Mutation, run by Kumquat Biosciences Inc. at 11 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- KRAS G12C Mutation, KRAS G12S Mutation, Solid Tumor Malignancies
- What is being tested?
- KQB365, Cetuximab and KQB198
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 11 sitesUnited States
- Study dates
- 4 Feb 2025to 30 Jun 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PART 1 (monotherapy and combo therapy with KQB198): Histologically confirmed diagnosis of a solid tumor malignancy with either a KRAS G12C or KRAS G12S mutation.
- PART 1 (combo therapy with Cetuximab) \& PART 2: Histologically confirmed diagnosis of adenocarcinoma of the colon or rectum with either a KRAS G12C or KRAS G12S mutation.
- PART 1 (monotherapy Non-Small Cell Lung Cancer Cohort): Histologically confirmed diagnosis of Non-Small Cell Lung Cancer 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
Who cannot join
- Active primary central nervous system tumors
- Cardiac abnormalities
- Active interstitial lung disease
- Unable to swallow or GI condition that prevents absorption for patients in KQB198 combination cohorts
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
United States11 sites, 11 recruiting
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Danielle Lindquist, 857-215-2351, daniellea_lindquist@dfci.harvard.edu
- Recruiting
Cleveland Clinic, Taussig Cancer Institute
Cleveland, Ohio, 44195
(216) 444-7923, TaussigResearch@ccf.org
- Recruiting
Sarah Cannon Cancer Institute at HealthONE
Denver, Colorado, 80218
720-754-2610, cann.ddudenvergeneral@sarahcannon.com
- Recruiting
NEXT Virginia, LLC
Fairfax, Virginia, 22031
Blake Patterson, 703-783-4505, bpatterson@nextoncology.com
- Recruiting
START Midwest
Grand Rapids, Michigan, 49546
Ashley Spagnuolo, 616-954-5552, ashley.spagnuolo@startresearch.com
- Recruiting
Mayo Clinic, Jacksonville
Jacksonville, Florida, 32224
855-776-0015
- Recruiting
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
Shamika Wright
- Recruiting
Sydney Kimmel Cancer Center
Philadelphia, Pennsylvania, 19107
Dennis Stone, 215-955-6000, Dennis.Stone@jefferson.edu
- Recruiting
Mayo Clinic, Phoenix
Phoenix, Arizona, 85054
855-776-0015
- Recruiting
Mayo Clinic, Rochester
Rochester, Minnesota, 55905
855-776-0015
- Recruiting
NEXT Oncology
San Antonio, Texas, 78229
Jordan Georg, 210-580-9521, jgeorg@nextoncology.com
About this study
Official title: A Phase 1/1b, Open-label, Multicenter, Dose Escalation and Dose Optimization Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB365 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies With KRAS G12S or G12C Mutations
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.
- Conditions
- KRAS G12C Mutation, KRAS G12S Mutation, Solid Tumor Malignancies, CRC (Colorectal Cancer), NSCLC, NSCLC (Non-small-cell Lung Cancer)
- Being tested
- KQB365, Cetuximab, KQB198
- Keywords
- cetuximab, KQB365, KQB198, kras, inhibitor
- Medical subject headings
- Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KQB365Drug
Intravenous KQB365
CetuximabDrug
Intravenous cetuximab
KQB198Drug
Oral KQB198
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy Dose Escalation (Part 1) | Experimental | Drug: KQB365
- Intravenous KQB365 Receives: Drug: KQB365 |
| Combo Therapy with Cetuximab Dose Escalation (Part 1) | Experimental | Drug: KQB365 - Intravenous KQB365
Drug:
- Intravenous cetuximab Receives: Drug: KQB365; Drug: Cetuximab |
| Monotherapy Dose Expansion - RP2D (Part 2) | Experimental | Drug: KQB365
- Intravenous KQB365 Receives: Drug: KQB365 |
| Monotherapy Dose Expansion - RP2D-1 (Part 2) | Experimental | Drug: KQB365
- Intravenous KQB365 Receives: Drug: KQB365 |
| Combo Therapy with Cetuximab Dose Expansion - RP2D (Part 2) | Experimental | Drug: KQB365 - Intravenous KQB365
Drug:
- Intravenous cetuximab Receives: Drug: KQB365; Drug: Cetuximab |
| Combo Therapy with Cetuximab Dose Expansion - RP2D-1 (Part 2) | Experimental | Drug: KQB365 - Intravenous KQB365
Drug:
- Intravenous cetuximab Receives: Drug: KQB365; Drug: Cetuximab |
| Combo Therapy with KQB198 Dose Escalation (Part 1) | Experimental | Drug: KQB365 - Intravenous KQB365
Drug:
- Oral KQB198 Receives: Drug: KQB365; Drug: KQB198 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: up to 35 months
Secondary outcomes (9)
Concentration-time curve (AUC)
Measured: up to 35 months
Maximum plasma concentration (Cmax)
Measured: up to 35 months
Time to maximum plasma concentration (tmax)
Measured: up to 35 months
Overall survival (OS)
Measured: up to 35 months
Progression-free survival (PFS)
using RECIST v1.1
Measured: up to 35 months
Overall response rate (ORR)
using RECIST v1.1
Measured: up to 35 months
Duration of response (DOR)
using RECIST v1.1
Measured: up to 35 months
Time to response (TTR)
using RECIST v1.1
Measured: up to 35 months
Disease control rate (DCR)
using RECIST v1.1
Measured: up to 35 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start4 Feb 2025
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KRAS G12C MutationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kumquat Biosciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06720987
- Sponsor's protocol ID
- KQB365-101
- Status last verified
- Oct 2026
- First submitted
- 3 Dec 2024
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/1b, Open-label, Multicenter, Dose Escalation and Dose Optimization Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB365 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies With KRAS G12S or G12C Mutations
- ClinicalTrials.gov ID
- NCT06720987
- Acronym / sponsor ID
- KQB365-101
- Conditions
- KRAS G12C Mutation, KRAS G12S Mutation, Solid Tumor Malignancies, CRC (Colorectal Cancer), NSCLC, NSCLC (Non-small-cell Lung Cancer)
- Keywords
- cetuximab, KQB365, KQB198, kras, inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Kumquat Biosciences Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Feb 2025 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Monotherapy Dose Escalation (Part 1) | Experimental | Drug: KQB365Drug: KQB365 - Intravenous KQB365 |
| Combo Therapy with Cetuximab Dose Escalation (Part 1) | Experimental | Drug: KQB365, Drug: CetuximabDrug: KQB365 - Intravenous KQB365 Drug: - Intravenous cetuximab |
| Monotherapy Dose Expansion - RP2D (Part 2) | Experimental | Drug: KQB365Drug: KQB365 - Intravenous KQB365 |
| Monotherapy Dose Expansion - RP2D-1 (Part 2) | Experimental | Drug: KQB365Drug: KQB365 - Intravenous KQB365 |
| Combo Therapy with Cetuximab Dose Expansion - RP2D (Part 2) | Experimental | Drug: KQB365, Drug: CetuximabDrug: KQB365 - Intravenous KQB365 Drug: - Intravenous cetuximab |
| Combo Therapy with Cetuximab Dose Expansion - RP2D-1 (Part 2) | Experimental | Drug: KQB365, Drug: CetuximabDrug: KQB365 - Intravenous KQB365 Drug: - Intravenous cetuximab |
| Combo Therapy with KQB198 Dose Escalation (Part 1) | Experimental | Drug: KQB365, Drug: KQB198Drug: KQB365 - Intravenous KQB365 Drug: - Oral KQB198 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- PART 1 (monotherapy and combo therapy with KQB198): Histologically confirmed diagnosis of a solid tumor malignancy with either a KRAS G12C or KRAS G12S mutation.
- PART 1 (combo therapy with Cetuximab) \& PART 2: Histologically confirmed diagnosis of adenocarcinoma of the colon or rectum with either a KRAS G12C or KRAS G12S mutation.
- PART 1 (monotherapy Non-Small Cell Lung Cancer Cohort): Histologically confirmed diagnosis of Non-Small Cell Lung Cancer with either a KRAS G12C or KRAS G12S mutation.
- Unresectable or metastatic disease
- No available treatment with curative intent
Key exclusion criteria (4 listed)
- Active primary central nervous system tumors
- Cardiac abnormalities
- Active interstitial lung disease
- Unable to swallow or GI condition that prevents absorption for patients in KQB198 combination cohorts
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KQB365Intravenous KQB365 | Drug | Combo Therapy with Cetuximab Dose Escalation (Part 1), Combo Therapy with Cetuximab Dose Expansion - RP2D (Part 2), Combo Therapy with Cetuximab Dose Expansion - RP2D-1 (Part 2), Combo Therapy with KQB198 Dose Escalation (Part 1), Monotherapy Dose Escalation (Part 1), Monotherapy Dose Expansion - RP2D (Part 2), Monotherapy Dose Expansion - RP2D-1 (Part 2) |
| CetuximabIntravenous cetuximab | Drug | Combo Therapy with Cetuximab Dose Escalation (Part 1), Combo Therapy with Cetuximab Dose Expansion - RP2D (Part 2), Combo Therapy with Cetuximab Dose Expansion - RP2D-1 (Part 2) |
| KQB198Oral KQB198 | Drug | Combo Therapy with KQB198 Dose Escalation (Part 1) |
Primary outcome
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
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.
Recommended Phase 2 Dose (RP2D) (Part 1)
Time frame: up to 35 months
Evaluate safety and assess number of patients with dose-limiting toxicity to determine the RP2D.
Efficacy and Optimal Biologic Dose of study treatment, as measured by Objective Response Rate (ORR) (Part 2)
Time frame: up to 35 months
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.
9 secondary outcomes
Concentration-time curve (AUC)
Time frame: up to 35 months
Maximum plasma concentration (Cmax)
Time frame: up to 35 months
Time to maximum plasma concentration (tmax)
Time frame: up to 35 months
Overall survival (OS)
Time frame: up to 35 months
Progression-free survival (PFS)
Time frame: up to 35 months
Overall response rate (ORR)
Time frame: up to 35 months
Duration of response (DOR)
Time frame: up to 35 months
Time to response (TTR)
Time frame: up to 35 months
Disease control rate (DCR)
Time frame: up to 35 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KQB365, Cetuximab and KQB198 in people with KRAS G12C Mutation and KRAS G12S Mutation, run by Kumquat Biosciences Inc. at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kumquat Clinical Development ((858) 214-2700, kumquatstudies@kumquatbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.