Trial Radar IA | ||
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Lo studio clinico NCT07431281 per Cancro gastrico, Adenocarcinoma della Giunzione Gastroesofagea, Cancro esofageo è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma Expressing Claudin18.2 Fase III 2.130
A Phase III, Multicentre, Randomised Controlled Study of Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in First-Line Claudin18.2-Positive, HER2-Negative, Advanced/Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (CLARITY-Gastric 02)
- D9803C00001
- 2024-519787-40-00 (Identificativo del registro) (Clinical Trials Information System (CTIS))
Advanced Gastric Adenocarcinoma,
Advanced Esophageal Adenocarcinoma,
Metastatic Gastric Adenocarcinoma,
Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma,
Metastatic Esophageal Adenocarcinoma,
Claudin 18.2,
PD-L1,
Human epidermal growth factor receptor 2 (HER2) Negative
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleArm A Sonesitatug vedotin + Rilvegostomig + Capecitabine | Sonesitatug vedotin Intravenous Rilvegostomig Intravenous Capecitabine Oral |
SperimentaleArm B Sonesitatug vedotin + Nivolumab + Capecitabine | Sonesitatug vedotin Intravenous Nivolumab Intravenous Capecitabine Oral |
Comparatore attivoArm C Nivolumab + CAPOX OR Nivolumab + FOLFOX
* nivolumab, capecitabine, oxaliplatin
* nivolumab, 5-Fluorouracil, leucovorin, oxaliplatin | Nivolumab Intravenous Capecitabine Oral 5-Fluorouracil Intravenous Oxaliplatin Intravenous Leucovorin Intravenous |
SperimentaleArm D Sonesitatug vedotin + Capecitabine | Sonesitatug vedotin Intravenous Capecitabine Oral |
Comparatore attivoArm E Zolbetuximab + CAPOX or Zolbetuximab + FOLFOX:
* zolbetuximab, capecitabine, oxaliplatin
* zolbetuximab, 5-Fluorouracil, leucovorin, oxaliplatin
CAPOX or FOLFOX:
* oxaliplatin, capecitabine,
* 5-Fluorouracil, leucovorin, oxaliplatin | Capecitabine Oral 5-Fluorouracil Intravenous Oxaliplatin Intravenous Zolbetuximab Intravenous Leucovorin Intravenous |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Progression Free Survival (PFS) (Cohort 1 and Cohort 2) | PFS is defined as time from randomisation until progression per RECIST 1.1, or death due to any cause, whichever occurs first. | Up to approximately 5 years |
Overall Survival (OS) (Cohort 1) | OS is defined as the time from randomisation until the date of death due to any cause. | Up to approximately 5 years |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Overall Survival (OS) (Cohort 2) | OS is defined as the time from randomisation until the date of death due to any cause. | Up to approximately 5 years |
Overall Survival (OS) (Cohort 1) | OS is defined as time from randomisation until date of death due to any cause. Arm B versus C. | Up to approximately 5 years |
Progression Free Survival (PFS) (Cohort 1) | PFS is defined as time from randomisation until progression per RECIST 1.1 or death due to any cause, whichever occurs first. Arms B versus C. | Up to approximately 5 years |
Objective Response Rate (ORR) (Cohort 1 and Cohort 2) | ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, per RECIST 1.1. | Up to approximately 5 years |
Duration of Response (DoR) (Cohort 1 and Cohort 2) | DoR (per RECIST 1.1) is derived for confirmed objective responses (CR or PR) only and is defined as the time from the date of first documented response (which is subsequently confirmed) until date of documented progression or death in the absence of disease progression (ie, date of PFS event - date of first response + 1). | Up to approximately 5 years |
Pharmacokinetics of sonesitatug vedotin (Cohort 1 and Cohort 2) | Pharmacokinetic parameters of sonesitatug vedotin (peak plasma concentration (Cmax)) | Up to approximately 5 years |
Pharmacokinetics of sonesitatug vedotin (Cohort 1 and Cohort 2) | Pharmacokinetic parameters of sonesitatug vedotin (trough plasma concentration (Cmin)) | Up to approximately 5 years |
Immunogenicity of sonesitatug vedotin (Cohort 1 and Cohort 2) | Presence of ADAs for sonesitatug vedotin in serum (confirmatory results: positive or negative, titres). | Up to approximately 5 years |
Pharmacokinetics of rilvegostomig (Cohort 1) | Pharmacokinetic parameters of rilvegostomig (peak plasma concentration (Cmax)) | Up to approximately 5 years |
Pharmacokinetics of rilvegostomig (Cohort 1) | Pharmacokinetic parameters of rilvegostomig (trough plasma concentration (Cmin)) | Up to approximately 5 years |
Immunogenicity of rilvegostomig (Cohort 1) | Presence of ADAs for rilvegostomig in serum (confirmatory results: positive or negative, titres). | Up to approximately 5 years |
Safety and tolerability (Cohort 1 and Cohort 2) | Safety and tolerability as evaluated in terms of incidence of AEs and SAEs | Up to approximately 5 years |
Capable of giving signed informed consent
Participant must be 18 years or the legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the informed consent.
Previously untreated histologically documented unresectable, locally advanced, or metastatic gastric, GEJ, or distal esophagus (distal third of the esophagus) adenocarcinoma
Positive CLDN18.2 expression, as determined prospectively by central IHC testing
Confirmed PD-L1 CPS status by central IHC testing and ICI eligibility per investigator judgement is required to determine cohort eligibility as described below:
- Cohort 1: PD-L1 positive as determined by central IHC testing and the participant is deemed ICI eligible per investigator judgement.
- Cohort 2: PD-L1 negative as determined by central IHC testing OR the participant is ICI ineligible
ECOG performance status of 0 or 1 with no deterioration to > 1 over the previous 2 weeks prior to baseline at screening and prior to randomisation.
Minimum life expectancy of ≥ 12 weeks.
At least one lesion (measurable and/or non-measurable) that can be accurately assessed by the investigator based on RECIST 1.1.
Adequate organ and bone marrow function as specified in the protocol
Body weight ≥ 35 kg.
Sex and contraceptive requirements
- Known HER2-positive status
- Significant or unstable gastric bleeding and/or untreated gastric ulcers.
- Active or history of autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment or assessed by investigator as not appropriate to participate due to undue risk are excluded.
- CNS pathology
- Clinically significant pleural effusions or ascites and/or pleural effusions or ascites that require drainage, peritoneal shunt, or indwelling catheter/drain.
- Require parenteral nutrition support due to gastric or gastrointestinal obstruction.
- Peripheral neuropathy, sensory or motor, ≥ CTCAE Grade 2 at screening.
- Persistent toxicities caused by previous anticancer therapy excluding alopecia, not yet improved to Grade ≤ 1 or baseline.
- Cardiac abnormalities as outlined in the protocol
- Uncontrolled diabetes or diabetic neuropathy within 3 months prior to randomisation.
- Infectious disease including active hepatitis A infection; uncontrolled hepatitis B and/or chronic or active hepatitis B with HBV DNA ≥ 100 IU/mL; Known chronic, active, or uncontrolled hepatitis C; HIV infection that is not well controlled
- Known partial or total DPD enzyme deficiency
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