Health TrialsbyHealthPanel

Safety and Efficacy of NK510 to Treat Gastric Cancer and Colorectal Cancer

ConditionsGastric Cancer (GC)Colorectal Cancer
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBase Therapeutics (Shanghai) Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Drained ascites ≥ 500ml, or B-ultrasound/CT in the supine position shows ascites depth ≥ 3cm.

Disqualifiers

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].

Trial design

Design model

Single group

Treatments tested in this trial

  • NK510

    Drug

    NK510 will be administered through intravenous infusion, once a week for a total of six times.

  • NK510

    Drug

    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.

Treatment groups

15 Participants
are divided into 2 treatment groups
Group A: Systemic therapy with NK510 via intravenous infusionExperimental treatment 1 intervention
Group B: Intraperitoneal perfusion therapy with NK510Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose-Limiting Toxicity

To evaluate the DLT during N510 treatment

Time frame
6 weeks
2

Overall response rate (ORR)

Effectiveness Metrics

Time frame
6 weeks
3

Puncture-free survival (PuFS)

Effectiveness Metrics

Time frame
6 weeks

Secondary outcomes

1

Progression-free survival (PFS)

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Base Therapeutics (Shanghai) Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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