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A First-in-human Dose Escalation and Optimization Phase I/IIa Study to Investigate Safety, Tolerability, PK, and Efficacy of the NaPi2b ADC TUB-040 in Patients with Platinum-resistant High-grade Ovarian Cancer (PROC) or R/r Adenocarcinoma Non-small Cell Lung Cancer (NSCLC)

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Trial Profile

A First-in-human Dose Escalation and Optimization Phase I/IIa Study to Investigate Safety, Tolerability, PK, and Efficacy of the NaPi2b ADC TUB-040 in Patients with Platinum-resistant High-grade Ovarian Cancer (PROC) or R/r Adenocarcinoma Non-small Cell Lung Cancer (NSCLC)

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 19 Aug 2026

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At a glance

  • Drugs GS 8824 (Primary)
  • Indications Adenocarcinoma; Non-small cell lung cancer; Ovarian cancer
  • Focus Adverse reactions; First in man; Proof of concept
  • Acronyms NAPISTAR1-01
  • Sponsors Tubulis

Most Recent Events

  • 21 May 2026 According to a Gilead Sciences media release, data from this study will be presented at ASCO 2026.
  • 21 Apr 2026 According to a Tubulis media release, data from Phase I/IIa NAPISTAR 1-01 trial has been accepted for a rapid oral presentation at the upcoming American Society of Clinical Oncology (ASCO) Meeting, being held May 29 -June 2, 2026, in Chicago.
  • 03 Mar 2026 Protocol has been amended to include one new arm (Experimental: Platinum resistant ovarian cancer in combination with Bevacizumab) , it has been changed from 2 to 3.

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