Solid Tumor MalignanciesPhase 1NCT06994806
A Study to Investigate the Safety and Efficacy of KQB168 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies
A Phase 1 study testing KQB168 and Pembrolizumab in people with Solid Tumor Malignancies, run by Kumquat Biosciences Inc. at 15 sites in United States.
Trial summary
The goal of this clinical trial is to learn if KQB168 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB168. The main questions it aims to answer are: What is the safe dose of KQB168 by itself or in combination with pembrolizumab? Does KQB168 alone or in combination with… 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?
- KQB168 and Pembrolizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 15 sitesUnited States
- Study dates
- 24 Jun 2025to 31 May 2028
- 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
- Histologically confirmed diagnosis of solid tumor malignancy.
- Unresectable or metastatic disease that has progressed on immunotherapy.
- 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
- History of lung diseases
- Any condition that may impair drug absorption or prevent oral dosing
- Known history of immune-mediated colitis and uncontrolled autoimmune diseases
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
United States15 sites, 15 recruiting
- Recruiting
NEXT Austin
Austin, Texas, 78758
Heather Watson, 737-610-5202, hwatson@nextoncology.com
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Heather Keaney, 216-444-3409, keaneyh@ccf.org
- Recruiting
Mary Crowley Cancer Research Centers
Dallas, Texas, 75230
Sangavi Manalan, 972-566-3014, sangavi.sethumanalan@scri.com
- Recruiting
Sarah Cannon Cancer Institute at HealthONE
Denver, Colorado, 80218
Brandon Johnson, 720-754-2610, brandon.johnson2@sarahcannon.com
- Recruiting
NEXT Virginia
Fairfax, Virginia, 22031
Referral Coordinator, (703) 783-4518, mdelarosa@nextoncology.com
- Recruiting
UT MD Anderson Cancer Center - Houston
Houston, Texas, 77030
Anupama Madhyannapu, 346-722-9365, admadhyannapu@mdanderson.org
- Recruiting
NEXT Huston
Houston, Texas, 77054
Emma Morales, (832) 384-7912, emorales@nextoncology.com
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
Jennifer Adams, 319-467-6774, jennifer-adams@uiowa.edu
- Recruiting
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224
Kendal Klein, 904-953-3545, Klein.Kendal@mayo.edu
- Recruiting
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Stephanie Kim, 323-865-0240, Stephanie.Kim2@med.usc.edu
- Recruiting
Yale Cancer Center- New Haven
New Haven, Connecticut, 06520
Priscilla Steve, 203-464-5564, Priscilla.steve@yale.edu
- Recruiting
Mayo Clinic - Phoenix
Phoenix, Arizona, 85054
Robby Bennett, 480-342-6641, bennettiii.robert@mayo.edu
- Recruiting
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
Siobhan Chantigian, 507-738-7036, chantigian.siobhan@mayo.edu
- Recruiting
NEXT Oncology
San Antonio, Texas, 78229
Jordan Georg, (210) 580-9521, jgeorg@nextoncology.com
- Recruiting
Florida Cancer Specialists - Sarasota
Sarasota, Florida, 34232
Sarah Gwirtz, 941-377-9993, sarah.gwirtz@flcancer.com
About this study
Official title: A Phase 1, Open-label, Multicenter, Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB168 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Malignancies
The goal of this clinical trial is to learn if KQB168 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB168. The main questions it aims to answer are:
- What is the safe dose of KQB168 by itself or in combination with pembrolizumab?
- Does KQB168 alone or in combination with pembrolizumab decrease the size of the tumor?
- What happens to KQB168 in the body?
Participants will:
- Take KQB168 daily, alone or in combination with pembrolizumab
- Visit the clinic about 8 times in the first 8 weeks, and then once every 3 weeks after that
- Conditions
- Solid Tumor Malignancies
- Being tested
- KQB168, Pembrolizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KQB168Drug
Oral KQB168
PembrolizumabDrug
Intravenous pembrolizumab
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy Dose Escalation | Experimental | Drug: KQB168 - Oral KQB168 Receives: Drug: KQB168 |
| Combo Therapy Dose Escalation | Experimental | Drug: KQB168 - Oral KQB168 Drug: pembrolizumab - Intravenous pembrolizumab Receives: Drug: KQB168; Drug: Pembrolizumab |
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 (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
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 36 months
Secondary outcomes (10)
Overall response rate (ORR)
Using RECIST v1.1
Measured: up to 36 months
Duration of response (DOR)
Using RECIST v1.1
Measured: up to 36 months
Time to response (TTR)
Using RECIST v1.1
Measured: up to 36 months
Disease control rate (DCR)
Using RECIST v1.1
Measured: up to 36 months
Progression-free survival (PFS)
Using RECIST v1.1
Measured: up to 36 months
Overall survival (OS)
using RECIST v1.1
Measured: up to 36 months
Concentration-time curve (AUC)
Measured: up to 36 months
Maximum plasma concentration (Cmax)
Measured: up to 36 months
Time to maximum plasma concentration (tmax)
Measured: up to 36 months
Pharmacologically Active Dose (PAD)
Assessment of tumor and systemic immune activation
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start24 Jun 2025
- Primary completion30 Nov 2027 (estimated)
- Study completion31 May 2028 (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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 84 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
- NCT06994806
- Sponsor's protocol ID
- KQB168-101
- Status last verified
- Feb 2026
- First submitted
- 12 May 2025
- Last updated
- 3 Mar 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 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Multicenter, Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB168 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT06994806
- Acronym / sponsor ID
- KQB168-101
- Conditions
- Solid Tumor Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Kumquat Biosciences Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Jun 2025 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 29 May 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 clinical trial is to learn if KQB168 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB168. The main questions it aims to answer are:
- What is the safe dose of KQB168 by itself or in combination with pembrolizumab?
- Does KQB168 alone or in combination with pembrolizumab decrease the size of the tumor?
- What happens to KQB168 in the body?
Participants will:
- Take KQB168 daily, alone or in combination with pembrolizumab
- Visit the clinic about 8 times in the first 8 weeks, and then once every 3 weeks after that
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monotherapy Dose Escalation | Experimental | Drug: KQB168Drug: KQB168 - Oral KQB168 |
| Combo Therapy Dose Escalation | Experimental | Drug: KQB168, Drug: PembrolizumabDrug: KQB168 - Oral KQB168 Drug: pembrolizumab - Intravenous pembrolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically confirmed diagnosis of solid tumor malignancy.
- Unresectable or metastatic disease that has progressed on immunotherapy.
- No available treatment with curative intent
- Adequate organ function
- Measurable disease per RECIST v1.1
Key exclusion criteria (5 listed)
- Active primary central nervous system tumors
- Cardiac abnormalities
- History of lung diseases
- Any condition that may impair drug absorption or prevent oral dosing
- Known history of immune-mediated colitis and uncontrolled autoimmune diseases
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 |
|---|---|---|
| KQB168Oral KQB168 | Drug | Combo Therapy Dose Escalation, Monotherapy Dose Escalation |
| PembrolizumabIntravenous pembrolizumab | Drug | Combo Therapy Dose Escalation |
Primary outcome
Number of patients who experience treatment-emergent adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
Time frame: up to 36 months
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.
10 secondary outcomes
Overall response rate (ORR)
Time frame: up to 36 months
Duration of response (DOR)
Time frame: up to 36 months
Time to response (TTR)
Time frame: up to 36 months
Disease control rate (DCR)
Time frame: up to 36 months
Progression-free survival (PFS)
Time frame: up to 36 months
Overall survival (OS)
Time frame: up to 36 months
Concentration-time curve (AUC)
Time frame: up to 36 months
Maximum plasma concentration (Cmax)
Time frame: up to 36 months
Time to maximum plasma concentration (tmax)
Time frame: up to 36 months
Pharmacologically Active Dose (PAD)
Time frame: up to 36 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 Mar 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.
15 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 KQB168 and Pembrolizumab in people with Solid Tumor Malignancies, run by Kumquat Biosciences Inc. at 15 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 5 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 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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 (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) (time frame: up to 36 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 Mar 2026.