Gastric CancerEarly Phase 1NCT06098898
Safety and Efficacy of NK510 to Treat Gastric Cancer
A Early Phase 1 study testing NK510 and Tislelizumab，atezolizumab or Trastuzumab in people with Gastric 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.NK510 will be administered in combination with PD-1 blockade or monoclonal anti-HER2 antibody. Patients are required to undergo a biopsy for confirmation of tumor PD-L1 and HER2 expression and. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- NK510 and Tislelizumab，atezolizumab or Trastuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 1 Nov 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age≥18 years;
- Confirmed by histology or cytology: Adenocarcinoma at the gastric or gastroesophageal junction, with locally advanced unresectable or distant metastasis. Tumor tissue can be provided for central laboratory confirmation of HER2 and PD-L1 expression status;
- Received standard treatment before screening, currently in a state of progression or recurrence of the disease;
- According to RECIST v1.1 (Solid Tumor Efficacy Evaluation Criteria), there is at least one CT measurable lesion present;
- ECOG physical status score of 0-2;
- Expected survival >=3 months;
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- Except for hair loss and fatigue, all previous anti-tumor treatments have alleviated toxicity to level 1 (CTCAE v5.0) or original baseline;
- Female of childbearing age must be non lactating and have a negative serum pregnancy test within 1 week prior to enrollment;
- Able to follow the research protocol and follow-up process;
- Voluntarily sign an informed consent form to participate in this study.
Who cannot join
- Individuals who have previously discontinued treatment with trastuzumab or PD-1 monoclonal antibody due to intolerance to drug toxicity reactions;
- Pregnant or lactating female patients;
- Patients with central nervous system metastasis (CNS) and/or cancerous meningitis and obvious symptoms;
- Having other malignant tumors that require active treatment within the past 3 years;
- Subjects with active, known or suspected autoimmune diseases [excluding type I diabetes, hypothyroidism requiring hormone replacement therapy only, skin diseases not requiring systemic treatment (such as vitiligo, psoriasis or alopecia) or diseases that are not expected to recur without external triggers;
- subjects have a history of immune deficiency, including HIV testing positive, or other acquired or congenital immune deficiency diseases or organ transplantation history;
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- Have a history of serious 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; At rest, the QTc interval obtained from a 12 lead electrocardiogram examination is>480 ms; Acute coronary syndrome, congestive heart failure, aortic dissection,stroke, or other Grade 3 or above cardiovascular and cerebrovascular events occurred within 6 months prior to enrollment; The New York Heart Association (NYHA) has a heart function rating of ≥ II or a left ventricular ejection fraction (LVEF) of<50%; Clinically uncontrollable hypertension;
- Radical radiotherapy was performed within 4 weeks prior to enrollment;Local palliative radiotherapy or Chinese herbal medicine/traditional Chinese patent medicines and simple preparations with anti-tumor indications within 2 weeks before enrollment;
- Not fully recovered from major surgery or trauma within 2 weeks prior to enrollment;
- Participated in research drug trials and received research treatment or used research instruments within 4 weeks before enrollment;
- Other anti-tumor treatments outside of this research protocol are currently underway or planned;
- Received blood transfusion, erythropoietin, granulocyte colony stimulating factor (G-CSF), or granulocyte macrophage colony stimulating factor treatment within 2 weeks prior to enrollment;
- Subjects who received systemic treatment with corticosteroids (prednisone>10 mg/day or equivalent) or other immunosuppressive/enhancing drugs (such as thymosin, interleukin-2, and interferon) within 2 weeks prior to enrollment. Allowing selected subjects to inhale or topically use corticosteroids in the absence of active autoimmune diseases;
- The virological examination of hepatitis B or hepatitis C during screening meets any of the following criteria:
- HBsAg positive and peripheral blood HBV-DNA titer detection ≥ 1×10^3 copies/mL or upper limit of normal value;
- HCV antibody positive;
- Meet any of the following standards:
- Hematological:Neutrophil count <1.5×10^9/L; Platelet count <75×10^9/L; Hemoglobin < 9 g/dL;
- Hepatic:ALT>3×ULN (tumor liver metastasis ≥ 5×ULN); AST>3×ULN (tumor liver metastasis ≥ 5×ULN); TBIL>1.5×ULN or TBIL>2.5(3.0 mg/dL) in Gilbert syndrome subjects;
- Renal:Serum creatinine>1.5×ULN or creatinine clearance<50mL/min;
- Any uncertain factors that affect the safety or compliance of patients;
- Researchers believe that any other serious or uncontrollable medical disease, active infection,abnormal physical examination, laboratory examination, mental state change, or mental illness increases the risk of the subject or affects the research results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploratory Study of NK510 Cell Therapy Combined With Monoclonal Antibody in the Treatment of Recurrent and Refractory Advanced Gastric Cancer
This study will evaluate the safety and efficacy of NK510 in the treatment of relapsed and refractory advanced gastric cancer.NK510 will be administered in combination with PD-1 blockade or monoclonal anti-HER2 antibody. Patients are required to undergo a biopsy for confirmation of tumor PD-L1 and HER2 expression and. The safety and efficacy of this treatment will be evaluated.
- Conditions
- Gastric Cancer
- Being tested
- NK510, Tislelizumab，atezolizumab or Trastuzumab
- Medical subject headings
- Stomach 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.3 infusions on Day 0，Day 2 and day 3 for a cycle，for a total of two cycles.
Tislelizumab，atezolizumab or TrastuzumabDrug
Administer according to the instructions.
| Study group | Role | What they receive |
|---|---|---|
| Group A (low-dose NK510 monotherapy) | Experimental | NK510 9×10^9 NK cells/dose. Receives: Drug: NK510 |
| Group B (low-dose NK510 combined mAbs) | Experimental | NK510 9×10^9 NK cells/dose. PD-1 blockade or anti-HER2 mAbs. Receives: Drug: NK510; Drug: Tislelizumab，atezolizumab or Trastuzumab |
| Group C (high-dose NK510 combined mAbs) | Experimental | NK510 12×10^9 NK cells/dose. PD-1 blockade or anti-HER2 mAbs. Receives: Drug: NK510; Drug: Tislelizumab，atezolizumab or Trastuzumab |
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
Maximal Tolerable Dose
To evaluate the MTD of NK510
Measured: 6 weeks
Secondary outcomes (1)
Overall response rate (ORR)
Effectiveness Metrics
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Dose escalation study
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Base Therapeutics (Shanghai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai 10th People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098898
- Sponsor's protocol ID
- NK510-08
- Status last verified
- Oct 2023
- First submitted
- 17 Oct 2023
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of NK510 Cell Therapy Combined With Monoclonal Antibody in the Treatment of Recurrent and Refractory Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT06098898
- Acronym / sponsor ID
- NK510-08
- Conditions
- Gastric Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Base Therapeutics (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai 10th People's Hospital
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 25 Oct 2023 (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.NK510 will be administered in combination with PD-1 blockade or monoclonal anti-HER2 antibody. Patients are required to undergo a biopsy for confirmation of tumor PD-L1 and HER2 expression and. The safety and efficacy of this treatment will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Dose escalation study
| Arm | Type | Receives |
|---|---|---|
| Group A (low-dose NK510 monotherapy) | Experimental | Drug: NK510NK510 9×10^9 NK cells/dose. |
| Group B (low-dose NK510 combined mAbs) | Experimental | Drug: NK510, Drug: Tislelizumab，atezolizumab or TrastuzumabNK510 9×10^9 NK cells/dose. PD-1 blockade or anti-HER2 mAbs. |
| Group C (high-dose NK510 combined mAbs) | Experimental | Drug: NK510, Drug: Tislelizumab，atezolizumab or TrastuzumabNK510 12×10^9 NK cells/dose. PD-1 blockade or anti-HER2 mAbs. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- age≥18 years;
- Confirmed by histology or cytology: Adenocarcinoma at the gastric or gastroesophageal junction, with locally advanced unresectable or distant metastasis. Tumor tissue can be provided for central laboratory confirmation of HER2 and PD-L1 expression status;
- Received standard treatment before screening, currently in a state of progression or recurrence of the disease;
- According to RECIST v1.1 (Solid Tumor Efficacy Evaluation Criteria), there is at least one CT measurable lesion present;
- ECOG physical status score of 0-2;
Key exclusion criteria (22 listed)
- Individuals who have previously discontinued treatment with trastuzumab or PD-1 monoclonal antibody due to intolerance to drug toxicity reactions;
- Pregnant or lactating female patients;
- Patients with central nervous system metastasis (CNS) and/or cancerous meningitis and obvious symptoms;
- Having other malignant tumors that require active treatment within the past 3 years;
- Subjects with active, known or suspected autoimmune diseases [excluding type I diabetes, hypothyroidism requiring hormone replacement therapy only, skin diseases not requiring systemic treatment (such as vitiligo, psoriasis or alopecia) or diseases that are not expected to recur without external triggers;
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.3 infusions on Day 0，Day 2 and day 3 for a cycle，for a total of two cycles. | Drug | Group A (low-dose NK510 monotherapy), Group B (low-dose NK510 combined mAbs), Group C (high-dose NK510 combined mAbs) |
| Tislelizumab，atezolizumab or TrastuzumabAdminister according to the instructions. | Drug | Group B (low-dose NK510 combined mAbs), Group C (high-dose NK510 combined mAbs) |
Primary outcome
Dose-Limiting Toxicity
Time frame: 6 weeks
To evaluate the DLT during N510 treatment
Maximal Tolerable Dose
Time frame: 6 weeks
To evaluate the MTD of NK510
1 secondary outcome
Overall response rate (ORR)
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 and Tislelizumab，atezolizumab or Trastuzumab in people with Gastric 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 10 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 25 Oct 2023. 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?
Results are not available in the source record.
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?
Dose-Limiting Toxicity (time frame: 6 weeks). 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 25 Oct 2023.