Solid Tumor MalignanciesPhase 1NCT07207707
A Study to Investigate the Safety and Efficacy of KQB548 in Participants With Advanced Solid Malignancies
A Phase 1 study testing KQB548 in people with Solid Tumor Malignancies, run by Kumquat Biosciences Inc. at 13 sites in United States.
Trial summary
The goal of this trial is to learn if KQB548 works to treat patients with advanced solid malignancies with a KRAS G12D mutation. It will also learn about the safety of KQB548. The main questions it aims to answer are: What is the safe dose of KQB548? Does KQB548 decrease the size of the tumor? What happens to KQB548… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor Malignancies
- What is being tested?
- KQB548
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 13 sitesUnited States
- Study dates
- 16 Sep 2025to Mar 2027
- 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
- Pathologically confirmed, locally advanced or metastatic PDAC, CRC, or NSCLC with a KRAS G12D mutation
- Progressed on, or intolerant to at least one prior line of systemic standard of care therapy
- Measurable disease according to RECIST v1.1
- Adequate organ function
Who cannot join
- Previous treatment with a KRAS G12D inhibitor or pan-RAS inhibitor
- History of intestinal disease, uncontrolled inflammatory bowel disease (e.g., Crohn's disease, Ulcerative Colitis), major esophageal or gastric surgery, or other gastrointestinal conditions (e.g., uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study intervention or result in inability to swallow oral medications
- Poorly controlled ascites and/or pleural effusion
- Requires treatment with a strong and/or moderate CYP3A inhibitor or inducer
- Requires treatment with a proton-pump inhibitor
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
United States13 sites, 13 recruiting
- Recruiting
NEXT Oncology - Austin
Austin, Texas, 78758
- Recruiting
The Christ Hospital
Cincinnati, Ohio, 45219
- Recruiting
SCRI - Denver
Denver, Colorado, 80218
- Recruiting
NEXT Virginia
Fairfax, Virginia, 22031
- Recruiting
START Midwest
Grand Rapids, Michigan, 49546
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
NEXT Oncology - Dallas
Irving, Texas, 75039
- Recruiting
University of California, San Diego
La Jolla, California, 92037
- Recruiting
University of California, Los Angeles
Los Angeles, California, 90095
- Recruiting
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
- Recruiting
University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, 84112
- Recruiting
NEXT Oncology - San Antonio
San Antonio, Texas, 78229
- Recruiting
Fred Hutchison Cancer Center
Seattle, Washington, 98195
About this study
Official title: A Phase 1a, Open-label, Multicenter, Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB548 in Participants With Advanced Solid Malignancies With a KRAS G12D Mutation
The goal of this trial is to learn if KQB548 works to treat patients with advanced solid malignancies with a KRAS G12D mutation. It will also learn about the safety of KQB548. The main questions it aims to answer are:
- What is the safe dose of KQB548?
- Does KQB548 decrease the size of the tumor?
- What happens to KQB548 in the body?
- Conditions
- Solid Tumor Malignancies
- Being tested
- KQB548
- Keywords
- KRAS, G12D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KQB548Drug
Oral KQB548
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy Dose Escalation | Experimental | Not described Receives: Drug: KQB548 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety,Tolerability, MTD/MAD and/or RDE in the Study Population
Safety characterized by type, incidence and severity of treatment emergent adverse events (TEAEs), SAEs, and DLTs
Measured: Up to 30 months
Secondary outcomes (13)
Plasma Concentration-time curve (AUC)
Measured: Up to 30 months
Maximum plasma concentration (Cmax)
Measured: Up to 30 months
Time to maximum plasma concentration (tmax)
Measured: Up to 30 months
Overall Response Rate (ORR)
Per RECIST v1.1
Measured: Up to 30 months
Duration of Response (DOR)
Per RECIST v1.1
Measured: Up to 30 months
Time to Response (TTR)
Per RECIST v1.1
Measured: Up to 30 months
Disease Control Rate (DCR)
Per RECIST v1.1
Measured: Up to 30 months
Progression Free Survival (PFS)
Per RECIST 1.1
Measured: Up to 30 months
Overall Survival (OS)
Per RECIST v1.1
Measured: Up to 30 months
Peak Plasma Concentration (Cmax) in Fed and Fasted States for Food Effect
Measured: Up to 30 months
Concentration Time Curve (AUC) in Fed and Fasted States for Food Effect
Measured: Up to 30 months
Time to maximum plasma concentration (tmax) in Fed and Fasted States for Food Effect
Measured: Up to 30 months
Evaluate Changes in QTc (mSec)
Measured: Up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start16 Sep 2025
- Primary completionSep 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor MalignanciesStudies 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
- 78 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
- NCT07207707
- Sponsor's protocol ID
- KQB548-101
- Status last verified
- Mar 2026
- First submitted
- 3 Sep 2025
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a, Open-label, Multicenter, Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB548 in Participants With Advanced Solid Malignancies With a KRAS G12D Mutation
- ClinicalTrials.gov ID
- NCT07207707
- Acronym / sponsor ID
- KQB548-101
- Conditions
- Solid Tumor Malignancies
- Keywords
- KRAS, G12D
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Kumquat Biosciences Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 6 Oct 2025 (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 trial is to learn if KQB548 works to treat patients with advanced solid malignancies with a KRAS G12D mutation. It will also learn about the safety of KQB548. The main questions it aims to answer are:
- What is the safe dose of KQB548?
- Does KQB548 decrease the size of the tumor?
- What happens to KQB548 in the body?
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: KQB548 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pathologically confirmed, locally advanced or metastatic PDAC, CRC, or NSCLC with a KRAS G12D mutation
- Progressed on, or intolerant to at least one prior line of systemic standard of care therapy
- Measurable disease according to RECIST v1.1
- Adequate organ function
Key exclusion criteria (5 listed)
- Previous treatment with a KRAS G12D inhibitor or pan-RAS inhibitor
- History of intestinal disease, uncontrolled inflammatory bowel disease (e.g., Crohn's disease, Ulcerative Colitis), major esophageal or gastric surgery, or other gastrointestinal conditions (e.g., uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study intervention or result in inability to swallow oral medications
- Poorly controlled ascites and/or pleural effusion
- Requires treatment with a strong and/or moderate CYP3A inhibitor or inducer
- Requires treatment with a proton-pump inhibitor
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 |
|---|---|---|
| KQB548Oral KQB548 | Drug | Monotherapy Dose Escalation |
Primary outcome
Safety,Tolerability, MTD/MAD and/or RDE in the Study Population
Time frame: Up to 30 months
Safety characterized by type, incidence and severity of treatment emergent adverse events (TEAEs), SAEs, and DLTs
13 secondary outcomes
Plasma Concentration-time curve (AUC)
Time frame: Up to 30 months
Maximum plasma concentration (Cmax)
Time frame: Up to 30 months
Time to maximum plasma concentration (tmax)
Time frame: Up to 30 months
Overall Response Rate (ORR)
Time frame: Up to 30 months
Duration of Response (DOR)
Time frame: Up to 30 months
Time to Response (TTR)
Time frame: Up to 30 months
Disease Control Rate (DCR)
Time frame: Up to 30 months
Progression Free Survival (PFS)
Time frame: Up to 30 months
Overall Survival (OS)
Time frame: Up to 30 months
Peak Plasma Concentration (Cmax) in Fed and Fasted States for Food Effect
Time frame: Up to 30 months
Concentration Time Curve (AUC) in Fed and Fasted States for Food Effect
Time frame: Up to 30 months
Time to maximum plasma concentration (tmax) in Fed and Fasted States for Food Effect
Time frame: Up to 30 months
Evaluate Changes in QTc (mSec)
Time frame: Up to 30 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 20 May 2026.
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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.
13 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 KQB548 in people with Solid Tumor Malignancies, run by Kumquat Biosciences Inc. at 13 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 4 inclusion and 5 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 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
Safety,Tolerability, MTD/MAD and/or RDE in the Study Population (time frame: Up to 30 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 20 May 2026.