Gastric Cancer (GC)Early Phase 1NCT07166263
Safety and Efficacy of NK510 to Treat Gastric Cancer and Colorectal Cancer
A Early Phase 1 study testing NK510 in people with Gastric Cancer (GC) and Colorectal Cancer, run by Base Therapeutics (Shanghai) Co., Ltd. at 1 site in China.
Trial summary
This study will evaluate the safety and efficacy of NK510 in the treatment of relapsed and refractory advanced gastric cancer and colorectal cancer.NK510 will be administered by intravenous infusion for systemic therapy and intraperitoneal perfusion therapy. The safety and efficacy of this treatment will be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer (GC), Colorectal Cancer
- What is being tested?
- NK510
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 16 Oct 2025to Dec 2027
- Phase
- Early 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
- Aged ≥ 18 years, regardless of gender.
- Gastric cancer and colorectal cancer that are inoperable and unresectable with radiotherapy: For gastric cancer, molecular diagnosis confirms that it is not AFP-producing gastric cancer.
- Progressive disease or recurrence after receiving ≥ 2 lines of treatment.
- Patients are divided into two groups (Group A and Group B) based on the presence or absence of peritoneal metastasis. The criteria for determining peritoneal metastasis are as follows:
- Drained ascites ≥ 500ml, or B-ultrasound/CT in the supine position shows ascites depth ≥ 3cm.
- Peritoneal metastasis confirmed by any of the following criteria:
Show all 11Show fewer
- Positive for exfoliated cancer cells in ascites. ii. Diagnosed as peritoneal metastatic carcinoma by imaging and symptoms. iii. Peritoneal metastasis confirmed by abdominal exploration. iv. Ascites confirmed as exudate by routine ascites examination and ascites biochemistry.
- At least one measurable lesion on CT or MRI according to RECIST v1.1 (Response Evaluation Criteria in Solid Tumors).
- ECOG performance status of 0-2.
- Expected survival period ≥ 3 months.
- Able to comply with the study protocol and follow-up procedures, and voluntarily sign the informed consent form for participation in this study.
Who cannot join
- Pregnant or lactating women.
- Subjects with central nervous system (CNS) metastases and/or carcinomatous meningitis with obvious symptoms.
- A history of other malignant tumors within the past 3 years.
- Subjects with active, known or suspected autoimmune diseases [excluding type 1 diabetes, hypothyroidism requiring only hormone replacement therapy, skin diseases that do not require systemic treatment (e.g., vitiligo, psoriasis, or alopecia), or diseases that are not expected to relapse without external triggers].
- Subjects with a history of immunodeficiency, including positive HIV test results, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
- A history of severe cardiovascular and cerebrovascular diseases, including but not limited to: severe cardiac rhythm or conduction abnormalities such as ventricular arrhythmias requiring clinical intervention, third-degree atrioventricular block, etc.; QTc interval > 480 ms on 12-lead electrocardiogram at rest; acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or higher cardiovascular and cerebrovascular events within 6 months before enrollment; New York Heart Association (NYHA) cardiac function classification ≥ class II or left ventricular ejection fraction (LVEF) < 50%; clinically uncontrolled hypertension.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanjing Drum Tower Hospital, Affiliated to the Medical School of Nanjing University
Nanjing, Jiangsu
Liu Qin, 025-68182923, gyethics@163.com
About this study
Official title: Exploratory Study of NK510 Cell Therapy in the Treatment of Recurrent and Refractory Advanced Gastric Cancer and Colorectal Cancer
This study will evaluate the safety and efficacy of NK510 in the treatment of relapsed and refractory advanced gastric cancer and colorectal cancer.NK510 will be administered by intravenous infusion for systemic therapy and intraperitoneal perfusion therapy. The safety and efficacy of this treatment will be evaluated.
- Conditions
- Gastric Cancer (GC), Colorectal Cancer
- Being tested
- NK510
- Medical subject headings
- Stomach Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NK510Drug
NK510 will be administered through intravenous infusion, once a week for a total of six times.
NK510Drug
NK510 will be administered through intraperitoneal perfusion on D1, D4, and D7 of the first week for a total of 3 times, with each 3-week cycle constituting a total of 2 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Systemic therapy with NK510 via intravenous infusion | Experimental | Systemic therapy with NK510 via intravenous infusion combined with PD-L1 or other regimens selected by the investigator Receives: Drug: NK510 |
| Intraperitoneal perfusion therapy with NK510 | Experimental | Intraperitoneal perfusion therapy with NK510 plus IL-2, PD-L1 or other regimens selected by the investigator for systemic therapy Receives: Drug: NK510 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicity
To evaluate the DLT during N510 treatment
Measured: 6 weeks
Overall response rate (ORR)
Effectiveness Metrics
Measured: 6 weeks
Puncture-free survival (PuFS)
Effectiveness Metrics
Measured: 6 weeks
Secondary outcomes (1)
Progression-free survival (PFS)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start16 Oct 2025
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer (GC)Studies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Base Therapeutics (Shanghai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07166263
- Sponsor's protocol ID
- NK510-13
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of NK510 Cell Therapy in the Treatment of Recurrent and Refractory Advanced Gastric Cancer and Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07166263
- Acronym / sponsor ID
- NK510-13
- Conditions
- Gastric Cancer (GC), Colorectal Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Base Therapeutics (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Oct 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Sep 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.
This study will evaluate the safety and efficacy of NK510 in the treatment of relapsed and refractory advanced gastric cancer and colorectal cancer.NK510 will be administered by intravenous infusion for systemic therapy and intraperitoneal perfusion therapy. The safety and efficacy of this treatment will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systemic therapy with NK510 via intravenous infusion | Experimental | Drug: NK510Systemic therapy with NK510 via intravenous infusion combined with PD-L1 or other regimens selected by the investigator |
| Intraperitoneal perfusion therapy with NK510 | Experimental | Drug: NK510Intraperitoneal perfusion therapy with NK510 plus IL-2, PD-L1 or other regimens selected by the investigator for systemic therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Aged ≥ 18 years, regardless of gender.
- Gastric cancer and colorectal cancer that are inoperable and unresectable with radiotherapy: For gastric cancer, molecular diagnosis confirms that it is not AFP-producing gastric cancer.
- Progressive disease or recurrence after receiving ≥ 2 lines of treatment.
- Patients are divided into two groups (Group A and Group B) based on the presence or absence of peritoneal metastasis. The criteria for determining peritoneal metastasis are as follows:
- At least one measurable lesion on CT or MRI according to RECIST v1.1 (Response Evaluation Criteria in Solid Tumors).
Key exclusion criteria (6 listed)
- Pregnant or lactating women.
- Subjects with central nervous system (CNS) metastases and/or carcinomatous meningitis with obvious symptoms.
- A history of other malignant tumors within the past 3 years.
- Subjects with active, known or suspected autoimmune diseases [excluding type 1 diabetes, hypothyroidism requiring only hormone replacement therapy, skin diseases that do not require systemic treatment (e.g., vitiligo, psoriasis, or alopecia), or diseases that are not expected to relapse without external triggers].
- Subjects with a history of immunodeficiency, including positive HIV test results, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
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 |
|---|---|---|
| NK510NK510 will be administered through intravenous infusion, once a week for a total of six times. | Drug | Systemic therapy with NK510 via intravenous infusion |
| NK510NK510 will be administered through intraperitoneal perfusion on D1, D4, and D7 of the first week for a total of 3 times, with each 3-week cycle constituting a total of 2 cycles. | Drug | Intraperitoneal perfusion therapy with NK510 |
Primary outcome
Dose-Limiting Toxicity
Time frame: 6 weeks
To evaluate the DLT during N510 treatment
Overall response rate (ORR)
Time frame: 6 weeks
Effectiveness Metrics
Puncture-free survival (PuFS)
Time frame: 6 weeks
Effectiveness Metrics
1 secondary outcome
Progression-free survival (PFS)
Time frame: 2 years
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 1 Oct 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.
Nanjing Drum Tower Hospital, Affiliated to the Medical School of Nanjing University
Nanjing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing NK510 in people with Gastric Cancer (GC) and Colorectal Cancer, run by Base Therapeutics (Shanghai) Co., Ltd. at 1 site in China.
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 11 inclusion and 6 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 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-Limiting Toxicity (time frame: 6 weeks). 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 1 Oct 2026.