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NCT06219941

AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2

StatusRecruiting
PhasePhase 2
Primary completion (estimated)
Track this trial

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Record History

All 20 versions: 17 with changes below, 3 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 31 words
    • Secondary endpoints: details revised at 4 of 9 entries
  2. Primary completion pushed from Aug 11, 2026 to Nov 17, 2026
    • Study completion moved earlier from Sep 30, 2027 to Jun 28, 2027
    • Enrollment target: 224 to 226
    v19
  3. Primary completion date: Dec 30, 2025 to Aug 11, 2026
    • Enrollment target: 190 to 224
    • Study sites: 51 to 52
    • Study completion date: Dec 31, 2026 to Sep 30, 2027
    v18
  4. Study sites: 50 to 51v17
  5. Study sites: 49 to 50v16
Show 11 earlier versionsHide 11 earlier versions
  1. Site details revised at 1 of 49 sitesv12
  2. Enrollment target: 123 to 190v11 Show 7 more changesShow less
    • Primary completion date: May 2, 2025 to Dec 30, 2025
    • Eligibility criteria expanded, about 144 words
    • Study completion date: Jan 19, 2027 to Dec 31, 2026
    • Secondary endpoints: details revised at 1 of 9 entries
    • Study description expanded, about 22 words
    • Site details revised at 13 of 49 sites
    • Study arms: 2 to 3
  3. Site details revised at 3 of 49 sitesv10
  4. Site details revised at 5 of 49 sitesv9
  5. Site details revised at 3 of 49 sitesv8
  6. Site details revised at 2 of 49 sitesv7
  7. Study sites: 47 to 49v6
  8. Site details revised at 6 of 47 sitesv5
  9. Study sites: 46 to 47v4
  10. Study sites: 39 to 46
    • Primary completion date: Apr 29, 2025 to May 2, 2025
    v3
  11. Study sites: 33 to 39
    • Primary completion date: Mar 25, 2025 to Apr 29, 2025
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Incidence of adverse events (AEs), serious AEs (SAEs). Changes from baseline in clinical laboratory parameters, vital signs, ECGs and physical examination. Rate of AEs leading to discontinuation of AZD0901, Occurrence of DLTs.
Timeframe: 30 days post treatment completion. AE Follow Up for 90 days post AZD0901 discontinuation.
Objective Response Rate (ORR).
Timeframe: From date of first dose of AZD0901 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years).

Secondary (9)

Overall Survival (OS)
Progression Free Survival (PFS)
Duration of Response (DoR)
Disease control rate (DCR)
Percentage change in tumor size
Show 4 moreShow less
Serum concentration of AZD0901 (total ADC), total antibody (conjugated and unconjugated) and total unconjugated MMAE
Serum PK parameters of AZD0901, total antibody (conjugated and unconjugated) and MMAE including but not limited to AUC, Cmax, tmax, clearance and half-life, as data allow.
Clinical activity by baseline and/or on-treatment tissue-based biomarkers including, but not limited to, gene expression, mutation profiles, DNA damage, protein expression, immune response and/or mechanisms of resistance.
ADA status will be determined along with prevalence and incidence of anti-drug antibodies to AZD0901, and titer established.

Arms and interventions

Sub Study 1 - AZD0901 MONOTHERAPYExperimental

Sub Study 1 will investigate AZD0901 monotherapy in order to evaluate the safety, tolerability, and efficacy of AZD0901.

Sub Study 2 - AZD0901 IN COMBINATION WITH ANTI-CANCER AGENTS IN PANCREATIC DUCTAL ADENOCARCINOMAExperimental

Substudy 2 will investigate the safety and efficacy of AZD0901 as first line systemic treatment used in combination with different chemotherapy agents

Sub Study 3: AZD0901 MONOTHERAPY IN BILIARY TRACT CANCERExperimental

Substudy 3 Further evaluate the preliminary anti-tumour activity of AZD0901 monotherapy by assessment of DRR.

Drugs: AZD0901, 5-Fluorouracil, Leucovorin, l-leucovorin, Irinotecan, Nanoliposomal Irinotecan, Gemcitabine

Sites

52 sites in 14 countries

United States 7, Japan 6, Malaysia 5, South Korea 5, Taiwan 5, Canada 4, Singapore 4, United Kingdom 4, Australia 3, Spain 3, China 2, Poland 2, Georgia 1, Moldova 1