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.

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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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

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:

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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

Nanjing Drum Tower Hospital, Affiliated to the Medical School of Nanjing University
Nanjing, Jiangsu
Liu Qin, 025-68182923, gyethics@163.com
Recruiting

Other trials in China

About this study

Official title: Exploratory Study of NK510 Cell Therapy in the Treatment of Recurrent and Refractory Advanced Gastric Cancer and Colorectal Cancer

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 groups in NCT07166263
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.

16 Oct 2025Dec 2027

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)

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

Interested in taking part?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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RecruitingObservational study
Anti-PD-1 in Combination With Systemic Chemotherapy With Nab-paclitaxel Intraperitoneal Infusion for Untreated Advanced Gastric Cancer With Malignant Ascites
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