NCT06219941Toboroz2. fázis
AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2
A Phase II, Open-label, Multi-centre Study to Evaluate Safety, Tolerability, Efficacy, PK, and Immunogenicity of AZD0901 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Tumours Expressing Claudin 18.2 (CLARITY-PanTumour01)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 30.
Rövid összefoglaló (regiszter, angolul)
The purpose of this study is to assess the safety, tolerability, efficacy, pharmacokinetics (PK), and immunogenicity of AZD0901 as monotherapy and in combination with anti-cancer agents in participants with locally advanced unresectable or metastatic solid tumours expressing CLDN18.2 .
- Állapot (regiszter)
- Toboroz
- Fázis (regiszter)
- 2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 226 (tervezett)
- Első benyújtás
- 2023. nov. 21.
- Kezdés
- 2023. dec. 13.
- Elsődleges befejezés
- 2026. nov. 17.
- Fő szponzor
- AstraZeneca
- Betegségek
- Hasnyálmirigyrák, Máj- és epeúti rák, Gyomor- és nyelőcsőrák
- NCT-szám
- NCT06219941
- EU CT-szám
- 2023-508275-37-00
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 2. fázis
- Tervezett résztvevők: 226
- 2023. dec. 13. és az elsődleges befejezés (2026. nov. 17.) között
- 47 helyszín, 14 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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- The list below is a summarised eligibility criteria for the study - refer to the study protocol for full criteria.
- Master Inclusion Criteria applicable to all sub studies:
- Participant must be ≥ 18 years or the legal age of consent at the time of signing the ICF.
- Participants who are CLDN18.2 positive.
- Must have at least one measurable lesion according to RECIST v1.1.
- ECOG performance status of 0 to 1 with no deterioration over the previous 2 weeks prior first day of dosing.
- Predicted life expectancy of ≥ 12 weeks.
- Adequate organ and bone marrow function as defined by protocol.
- Body weight \> 35 kg.
- Participants are willing to comply with contraception requirements.
- Sub study 1 Specific Inclusion criteria:
- Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction.
- Advanced or metastatic GC/GEJC.
- Maximum 2 prior lines of systemic treatment for unresectable or metastatic disease.
- Sub study 2 Specific Inclusion criteria:
- Participants diagnosed with histologically confirmed metastatic or advanced PDAC.
- Availability of an archival sample or a fresh tumour biopsy taken at screening.
- No prior treatments for unresectable or metastatic disease. Prior neoadjuvant/adjuvant chemotherapy is permitted as long as participants progressed ≥ 6 months (183 days) from the last dose.
- Sub study 3 Specific Inclusion criteria
- Histologically confirmed, unresectable advanced, or metastatic adenocarcinoma of biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma (NOTE: Ampullary cancers are not eligible).
- Documented radiographic or clinical disease progression on or after at least one prior regimen and maximum 2 prior lines of systemic treatment for unresectable or metastatic disease.
- Master Exclusion Criteria applicable to all sub studies:
- Unstable or active peptic ulcer disease or digestive tract bleeding including but not limited to clinically significant bleeding in the setting of prior CLDN18.2 directed therapy.
- Participants with clinically significant ascites that require drainage.
- A history of drug-induced non-infectious ILD/pneumonitis.
- Central nervous system metastases or CNS pathology.
- Peripheral neuropathy, sensory, or motor ≥ Grade 2 at screening.
- History of another primary malignancy.
- Prior exposure to any MMAE-based ADC.
- Prior exposure to any CLDN18.2 targeted agents except anti-CLDN18.2 monoclonal antibody.
- Sub study 1 Specific Exclusion criteria:
- Participants with HER2-positive (3+ by IHC, or 2+ by IHC, and positive by ISH) or indeterminate GC/GEJC unless they have failed/not tolerated/or are not eligible for standard anti-HER2 therapy, where available.
- Any factors that increase the risk of QTc prolongation or risk of arrhythmic events.
- The use of concomitant medications known to prolong the QT/QTc interval.
- Sub study 2 Specific Exclusion criteria:
- Known DPD enzyme deficiency based on local testing where testing is SoC.
- Use of strong inhibitor or inducer of UGT1A1.
- Use of strong inhibitors or inducers of CYP3A4.
- Known homozygous for the UGT1A1\*28 allele based on local testing where testing is SoC.
- Sub study 3 Specific Exclusion criteria
- Clinically significant biliary obstruction that has not resolved before enrollment.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (47)
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