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Life sciences · Phase 1 Trial
ClinicalTrials.gov · October 15, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 1 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
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Registry record from ClinicalTrials.gov (NCT07875920). This is a study registration, not published results. Lead sponsor: Neowise Biotechnology. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 66 participants (ESTIMATED). Conditions: Advanced Solid Cancer, Pancreatic Ductal Adenocarcinoma (PDAC), Colorectal Adenocarcinoma, Lung Adenocarcinoma, KRAS G12V, Pancreatic Cancer, Colorectal Cancer. Interventions: DRUG: Fludarabine; DRUG: Cyclophosphamide; BIOLOGICAL: NW-301V. Primary outcome measures: Phase 1a: Safety and tolerability of NW-301V in participants with advanced solid tumors , Through the study completion, an average of 2 years; Phase 1a: Maximum tolerated dose (MTD, if applicable) and provisional Recommended Phase 2 Dose (RP2D) , 28 days; Phase 1b: Safety and tolerability of NW-301V in PDAC, CRC and LUAD respectively under provisional RP2D , Through the study completion, an average of 2 years; Phase 1b: Final RP2D of NW-301V , Up to 2 years. Brief summary: This is a single-arm, multicenter, open-label, Phase 1a/1b dose-escalation and dose-expansion study designed to evaluate the safety, preliminary antitumor activity, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of NW-301V, an autologous TCR-T cell therapy, in Chinese adult participants with advanced malignant solid tumors harboring a KRAS G12V mutation.