WHO ICTRP trial
A study to evaluate the safety and efficacy of SOT102 as a single drug or in…
EUCTR2021-005873-25-ES · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2021-005873-25-ES |
|---|---|
| Public title | A study to evaluate the safety and efficacy of SOT102 as a single drug or in combination with standard of care treatment, in patients with stomach and pancreas cancer |
| Scientific title | A multicentric phase 1/2 trial to evaluate the safety and efficacy of SOT102 as monotherapy and in combination with standard of care treatment in patients with gastric and pancreatic adenocarcinoma |
| Primary sponsor | SOTIO Biotech a.s. |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | United States;France;Czechia;Belgium;Spain |
| Conditions | Gastric and pancreatic adenocarcinoma MedDRA version: 21.1 Level: LLT Classification code 10066354 Term: Adenocarcinoma of the gastroesophageal junction System Organ Class: 100000004864 MedDRA version: 21.1 Level: LLT Classification code… |
| Interventions | Product Name: SOT102 Product Code: SOT102 Pharmaceutical Form: Solution for infusion INN or Proposed INN: antibody-drug conjugate of an anti-CLDN18.2 mAb and the cytotoxic drug PNU159682, coupled by a Gly2-EDA linker Current Sponsor code… |
| Registration date | Jan 17, 2022 |
| Target size | 269 |
| Secondary IDs | SN201;157062 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: