Esophageal CancerPhase 1/2NCT05438420
Oral Axl/Mer/CSF1R Selective Tyrosine Kinase Inhibitor Q702 in Combination With Pembrolizumab in Patients With Selected Advanced Solid Tumors
A Phase 1/2 study testing Q702 and Pembrolizumab in people with Esophageal Cancer and Gastric Cancer, run by Qurient Co., Ltd. at 7 sites in 2 countries.
Trial summary
This study is a phase 1B/2 open-label, study to determine safety and preliminary efficacy of Q702 in combination with pembrolizumab in study subjects with advanced esophageal, gastric/GEJ, hepatocellular, and cervical cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Gastric Cancer, Hepatocellular Cancer
- What is being tested?
- Q702 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
- 120 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 12 Jan 2023to 30 Mar 2028
- Phase
- Phase 1/2
- 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
- The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
- Subjects with histologically or cytologically confirmed advanced or metastatic esophageal, gastric/GEJ, hepatocellular and cervical cancers who have progressed on treatment with an anti-PD1 or anti PD-L1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other therapies
- Have measurable disease per RECIST v 1.1. as assessed by local site investigator/radiology
- Have an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Life expectancy of at least 3 months
Who cannot join
- A WOCBP who has a positive urine pregnancy test (within 72 hours) prior to treatment or breast-feeding women
- Concomitant use of strong inhibitors and inducers of CYP1A2, 2J2, 2C19, 2D6, and 3A4/5 within the timeline duration of five half-lives prior to starting study drug and throughout the trial
- Concomitant use of sensitive substrates of CYP2C9, 2C19, and 3A4 within the timeline duration of five half-lives prior to starting study drug and throughout the trial
- Has received prior radiotherapy within 2 weeks of start of study treatment or have had a history of radiation pneumonitis
- Has had an allogeneic tissue/solid organ transplant
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
South Korea5 sites
CHA Bundang Medical Center
Seongnam-si
Asan Medical Center
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Severance Hospital
Seoul
United States2 sites
University of Southern California
Los Angeles, California, 90033
Norton Cancer Institute
Louisville, Kentucky, 40202
About this study
Official title: A Phase 1B/2, Open-label Study of Q702 in Combination With Intravenous Pembrolizumab in Patients With Selected Advanced Solid Tumors
This study is a phase 1B/2 open-label, study to determine safety and preliminary efficacy of Q702 in combination with pembrolizumab in study subjects with advanced esophageal, gastric/GEJ, hepatocellular, and cervical cancers.
- Being tested
- Q702, Pembrolizumab
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms, Liver Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Q702Drug
The study drug Q702 will be administered once daily by mouth on Days 1 through 7, Days 15 through 21 and Days 29 through 35 of every treatment cycle.
PembrolizumabBiological
Also called KEYTRUDA®
Pembrolizumab will be administered using IV infusion on Day 1 of each 3-week treatment cycle
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation of Q702 in combination with fixed dose of pembrolizumab | Experimental | Give one week on/one week off at selected dose level Receives: Drug: Q702; Biological: Pembrolizumab |
| Dose expansion of Q702 in combination with fixed dose of pembrolizumab | Experimental | Give intravenously once every three week at 200 mg Receives: Drug: Q702; Biological: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE
Measured: Up to approximately 2 years (Each Cycle is 42 Days)
Tumor response using RECIST version 1.1 throughout study
Measured: Up to approximately 2 years (Each Cycle is 42 Days)
Secondary outcomes (1)
Change in the area under curve (AUC) of Q702 and its primary metabolites
Measured: Cycle 1 Day 1 and Day 22 (Each Cycle is 42 Days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start12 Jan 2023
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qurient Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05438420
- Sponsor's protocol ID
- QRNT-008
- Other IDs
- MK-3475-D35 (KEYNOTE-D35)
- Status last verified
- Feb 2026
- First submitted
- 20 May 2022
- Last updated
- 24 Feb 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1B/2, Open-label Study of Q702 in Combination With Intravenous Pembrolizumab in Patients With Selected Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05438420
- Acronym / sponsor ID
- QRNT-008
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Qurient Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 30 Jun 2022 (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.
This study is a phase 1B/2 open-label, study to determine safety and preliminary efficacy of Q702 in combination with pembrolizumab in study subjects with advanced esophageal, gastric/GEJ, hepatocellular, and cervical cancers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose escalation of Q702 in combination with fixed dose of pembrolizumab | Experimental | Drug: Q702, Biological: PembrolizumabGive one week on/one week off at selected dose level |
| Dose expansion of Q702 in combination with fixed dose of pembrolizumab | Experimental | Drug: Q702, Biological: PembrolizumabGive intravenously once every three week at 200 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
- Subjects with histologically or cytologically confirmed advanced or metastatic esophageal, gastric/GEJ, hepatocellular and cervical cancers who have progressed on treatment with an anti-PD1 or anti PD-L1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other therapies
- Have measurable disease per RECIST v 1.1. as assessed by local site investigator/radiology
- Have an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Life expectancy of at least 3 months
Key exclusion criteria (5 listed)
- A WOCBP who has a positive urine pregnancy test (within 72 hours) prior to treatment or breast-feeding women
- Concomitant use of strong inhibitors and inducers of CYP1A2, 2J2, 2C19, 2D6, and 3A4/5 within the timeline duration of five half-lives prior to starting study drug and throughout the trial
- Concomitant use of sensitive substrates of CYP2C9, 2C19, and 3A4 within the timeline duration of five half-lives prior to starting study drug and throughout the trial
- Has received prior radiotherapy within 2 weeks of start of study treatment or have had a history of radiation pneumonitis
- Has had an allogeneic tissue/solid organ transplant
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 |
|---|---|---|
| Q702The study drug Q702 will be administered once daily by mouth on Days 1 through 7, Days 15 through 21 and Days 29 through 35 of every treatment cycle. | Drug | Dose escalation of Q702 in combination with fixed dose of pembrolizumab, Dose expansion of Q702 in combination with fixed dose of pembrolizumab |
| PembrolizumabAlso: KEYTRUDA®Pembrolizumab will be administered using IV infusion on Day 1 of each 3-week treatment cycle | Biological | Dose escalation of Q702 in combination with fixed dose of pembrolizumab, Dose expansion of Q702 in combination with fixed dose of pembrolizumab |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE
Time frame: Up to approximately 2 years (Each Cycle is 42 Days)
Tumor response using RECIST version 1.1 throughout study
Time frame: Up to approximately 2 years (Each Cycle is 42 Days)
1 secondary outcome
Change in the area under curve (AUC) of Q702 and its primary metabolites
Time frame: Cycle 1 Day 1 and Day 22 (Each Cycle is 42 Days)
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 24 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Q702 and Pembrolizumab in people with Esophageal Cancer and Gastric Cancer, run by Qurient Co., Ltd. at 7 sites in 2 countries.
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: under way, not looking for participants, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Korea, 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE (time frame: Up to approximately 2 years (Each Cycle is 42 Days)). The study lists 2 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 24 Feb 2026.