Advanced Solid TumorsPhase 1NCT07542704
A Study to Investigate the Safety and Efficacy of KQB368 as Monotherapy in Participants With Advanced Solid Malignancies
A Phase 1 study testing KQB368 in people with Advanced Solid Tumors and Colorectal Cancer (CRC), run by Kumquat Biosciences Inc. at 14 sites in United States.
Trial summary
The goal of this study is to learn if KQB368 works to treat advanced solid malignancies in adults. The study will also learn about the safety of KQB368. The main questions the study aims to answer are: What is the safe dose of KQB368 as a monotherapy? Does KQB368 decrease the size of the tumor? What happens to KQB368… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors, Colorectal Cancer (CRC), Non-Small Cell Lung Cancer
- What is being tested?
- KQB368
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 14 sitesUnited States
- Study dates
- 27 May 2026to Dec 2029
- 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
- Histologically confirmed diagnosis of a solid tumor
- Malignancy 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
- Must be able to swallow with no GI condition that prevents absorption
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
United States14 sites, 14 recruiting
- Recruiting
NEXT Oncology Austin
Austin, Texas, 78758
Sheena Sahota MD, 858-214-2700, kumquatstudies@kumquatbio.com
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Leon Pappas, 858-214-2700, kumquatstudies@kumquatbio.com
- Recruiting
UH Cleveland Medical Center
Cleveland, Ohio, 44106
Matthew Mirsky, 8582142729, kumquatstudies@kumquatbio.com
- Recruiting
START Dallas Fort Worth
Dallas, Texas, 76104
Henry Xiong, 858-214-2700, kumquatstudies@kumquatbio.com
- Recruiting
Karmanos Cancer Institute
Detroit, Michigan, 48201
Wasif Saif, kumquatstudies@kumquatbio.com
- Recruiting
NEXT Oncology Virginia
Fairfax, Virginia, 22031
Alexander Spira MD, 858-214-2700, kumquatstudies@kumquatbio.com
- Recruiting
John Theurer Cancer Center at Hackensack UMC
Hackensack, New Jersey, 07601
Miguel Gonzalez, 858-214-2700, kumquatstudies@kumquatbio.com
- Recruiting
START Los Angeles
Los Angeles, California, 90025
Navid Hafez, 858-214-2700, kumquatstudies@kumquatbio.com
- Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
Deepak Bhamidipati, 8582142729, kumquatstudies@kumquatbio.com
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Rona Yaeger, 8582142729, kumquatstudies@kumquatbio.com
- Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Anthony Olszanski, 858-214-2700, kumquatstudies@kumquatbio.com
- Recruiting
Providence Cancer Institute
Portland, Oregon, 97213
Rachel Sanborn, 858-214-2700, kumquatstudies@kumquatbio.com
- Recruiting
University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Theresa Werner, 858-214-2700, kumquatstudies@kumquatbio.com
- Recruiting
START San Antonio
San Antonio, Texas, 78229
Drew Rasco, kumquatstudies@kumquatbio.com
About this study
Official title: A Phase 1/1b, Open-label, Multicenter, Dose Escalation and Dose Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB368 in Participants With Advanced Solid Malignancies With KRAS G12S or G12C Mutations
The goal of this study is to learn if KQB368 works to treat advanced solid malignancies in adults. The study will also learn about the safety of KQB368. The main questions the study aims to answer are:
- What is the safe dose of KQB368 as a monotherapy?
- Does KQB368 decrease the size of the tumor?
- What happens to KQB368 in the body?
Participants will:
- Take KQB368 orally daily in 21-day cycles
- Return to the study site about 7 times in the first 5 weeks, and then once at the beginning of every 21-day cycle after that
- Conditions
- Advanced Solid Tumors, Colorectal Cancer (CRC), Non-Small Cell Lung Cancer, Uterine Cancer, KRAS G12C Mutations, KRAS G12S Mutations
- Being tested
- KQB368
- Keywords
- KQB368
- Medical subject headings
- Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KQB368Drug
Oral KQB368
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy Dose Escalation | Experimental | Not described Receives: Drug: KQB368 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective
Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities.
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: Up to 44 months
Secondary outcomes (9)
Objective response rate (ORR)
Evaluate efficacy of study treatment, as measured by Objective Response Rate (ORR) using Response Evaluation Criteria (RECISTv1.1). Objective response 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 first dose of study treatment until last dose.
Measured: Up to 44 months
Overall survival (OS)
Evaluate efficacy of study treatment characterized by OS. Overall survival is defined as the time from start of treatment to death.
Measured: Up to 44 months
Duration of response (DOR)
Duration of response is defined as the time from date of the first documentation of objective tumor response (CR or PR) based on RECIST v1.1 to the first documentation of either PD or death due to any cause, whichever occurs first.
Measured: Up to 44 months
Time to response (TTR)
Time to response is defined as time from first dose of study treatment to date of first documentation of objective tumor response (CR or PR) based on RECIST v1.1.
Measured: Up to 44 months
Disease control rate (DCR)
Disease control rate is the proportion of subjects that experience confirmed complete response (CR), partial response (PR), or stable disease based on RECIST v1.1 during the time period from first dose of study treatment until last dose.
Measured: Up to 44 months
Progression-free survival (PFS)
Progression-free survival is defined as the time from enrollment to the date of Progressive Disease (PD) based on RECIST v1.1 or death due to any cause, whichever occurs first.
Measured: Up to 44 months
Area under the concentration-time curve (AUC)
Measured: Up to 44 months
Maximum plasma concentration (Cmax)
Measured: Up to 44 months
Time to maximum plasma concentration (tmax)
Measured: Up to 44 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start27 May 2026
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kumquat Biosciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Worldwide Clinical Trials
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542704
- Sponsor's protocol ID
- KQB368-101
- Status last verified
- Oct 2026
- First submitted
- 13 Apr 2026
- 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 Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB368 in Participants With Advanced Solid Malignancies With KRAS G12S or G12C Mutations
- ClinicalTrials.gov ID
- NCT07542704
- Acronym / sponsor ID
- KQB368-101
- Conditions
- Advanced Solid Tumors, Colorectal Cancer (CRC), Non-Small Cell Lung Cancer, Uterine Cancer, KRAS G12C Mutations, KRAS G12S Mutations
- Keywords
- KQB368
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Kumquat Biosciences Inc.Industry (pharma, biotech, devices)
- Collaborators
- Worldwide Clinical Trials
- Study start
- 27 May 2026 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 21 Apr 2026 (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 study is to learn if KQB368 works to treat advanced solid malignancies in adults. The study will also learn about the safety of KQB368. The main questions the study aims to answer are:
- What is the safe dose of KQB368 as a monotherapy?
- Does KQB368 decrease the size of the tumor?
- What happens to KQB368 in the body?
Participants will:
- Take KQB368 orally daily in 21-day cycles
- Return to the study site about 7 times in the first 5 weeks, and then once at the beginning of every 21-day cycle after that
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monotherapy Dose Escalation | Experimental | Drug: KQB368 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| KQB368Oral KQB368 | Drug | Monotherapy Dose Escalation |
Primary outcome
Primary Objective
Time frame: Up to 44 months
Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities. 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.
9 secondary outcomes
Objective response rate (ORR)
Time frame: Up to 44 months
Overall survival (OS)
Time frame: Up to 44 months
Duration of response (DOR)
Time frame: Up to 44 months
Time to response (TTR)
Time frame: Up to 44 months
Disease control rate (DCR)
Time frame: Up to 44 months
Progression-free survival (PFS)
Time frame: Up to 44 months
Area under the concentration-time curve (AUC)
Time frame: Up to 44 months
Maximum plasma concentration (Cmax)
Time frame: Up to 44 months
Time to maximum plasma concentration (tmax)
Time frame: Up to 44 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.
14 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 KQB368 in people with Advanced Solid Tumors and Colorectal Cancer (CRC), run by Kumquat Biosciences Inc. at 14 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?
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 14 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 Telephone (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?
Primary Objective (time frame: Up to 44 months). 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.