Safety and Efficacy of NK510 to Treat Gastric Cancer

NCT06098898 | Unknown Early Phase 1

• 1 other identifier: NK510-08
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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. The safety and efficacy of this treatment will be evaluated.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (2)

• Dose-Limiting Toxicity

  To evaluate the DLT during N510 treatment

  6 weeks

• Maximal Tolerable Dose

  To evaluate the MTD of NK510

  6 weeks

Secondary Outcomes (1)

• Overall response rate (ORR)

  6 weeks

Study Arms (3)

Group A (low-dose NK510 monotherapy)

EXPERIMENTAL

NK510 9×10\^9 NK cells/dose.

Drug: NK510

Group B (low-dose NK510 combined mAbs)

EXPERIMENTAL

NK510 9×10\^9 NK cells/dose. PD-1 blockade or anti-HER2 mAbs.

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.

Drug: NK510; Drug: Tislelizumab，atezolizumab or Trastuzumab

Interventions

NK510 DRUG

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.

Group A (low-dose NK510 monotherapy); Group B (low-dose NK510 combined mAbs); Group C (high-dose NK510 combined mAbs)

Tislelizumab，atezolizumab or Trastuzumab DRUG

Administer according to the instructions.

Group B (low-dose NK510 combined mAbs); Group C (high-dose NK510 combined mAbs)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Base Therapeutics (Shanghai) Co., Ltd.: lead
• Shanghai 10th People's Hospital: collaborator

Study Sites (1)

Shanghai Tenth People's Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose escalation study

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 25, 2023
• Study Start: November 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: October 25, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)