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NK521 in the Treatment of Advanced Solid Tumors

StatusNot Yet Recruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 7 months later Oct 2027 → Jun 2028
See other at-risk trials from Base Therapeutics (Shanghai) Co., Ltd.

Record History

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  1. Primary completion pushed from Oct 2027 to Jun 2028
    • Start date: Jun 2026 to Jan 2027
    • Study completion pushed from Jul 2028 to Dec 2028
    • Eligibility criteria expanded, about 8 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Eligible subjects with advanced hepatocellular carcinoma and ovarian cancer will be divided into two treatment groups based on the volume of ascites. Group A consists of patients with mild ascites, who will receive NK521 via intravenous infusion. Group B includes patients with moderate to severe ascites, who will be treated with investigator-selected systemic regimens combined with intraperitoneal perfusion of NK521. Systemic and local medications will be administered in accordance with the treatment regimens of respective groups, and the safety of the study drug will be monitored. Preliminary anti-tumor efficacy will be assessed using the RECIST 1.1 criteria at Week 6 after the first infusion of NK521. Catheter placement and ascites drainage will be performed 3 days prior to the first intraperitoneal perfusion of NK521. After the initial intraperitoneal perfusion treatment, the therapeutic effect on ascites will be evaluated per the WHO criteria for ascites assessment.
Trial Details
NCT Number NCT07657416
Lead Sponsor Base Therapeutics (Shanghai) Co., Ltd.
Conditions
(from sponsor)		 Hepatocellular Carcinoma (HCC), Ovarian Cancer, Malignant Ascites
Related terms Carcinoma, Hepatocellular, Ovarian Neoplasms
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov