Pancreatic Cancer Clinical Trial
Official 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
This trial will assess the MTD and RP2D of SOT102 administered as monotherapy (Part A) and in combination with first-line SoC treatment (mFOLFOX6 with nivolumab and nab-paclitaxel/ gemcitabine; Part B) and efficacy of SOT102 administered as monotherapy (Part C) and in combination with first-line SoC treatment (Part D) in patients with advanced inoperable or metastatic gastric/GEJ adenocarcinoma or inoperable or metastatic pancreatic adenocarcinoma.
The trial will have the following parts: - Part A: Dose escalation, first-in-human, single-agent phase 1 trial of SOT102 in advanced/metastatic gastric/GEJ or pancreatic cancer patients with unmet medical need (CLDN18.2 agnostic) - Part B gastric cohort: Phase 1b dose escalation combination trial of SOT102 in combination with mFOLFOX6 and nivolumab as SoC regimen for first-line treatment of patients with advanced/metastatic gastric/GEJ cancer (CLDN18.2 agnostic) - Part B pancreatic cohort: Phase 1b dose escalation combination trial of SOT102 in combination with nab-paclitaxel/gemcitabine as SoC regimen for first-line treatment of patients with advanced/metastatic pancreatic cancer (CLDN18.2 agnostic) Once an RP2D in the respective phase 1 evaluation (Part A and Part B) has been identified expansion cohorts for gastric/GEJ and pancreatic cancer (Part C and Part D) are planned: - Part C gastric cohort: Single-agent SOT102 expansion at RP2D identified in Part A in gastric/GEJ cancer after two or more prior systemic therapies (third+ line) for locally advanced or metastatic disease (CLDN18.2 positive) - Part C pancreatic cohort: Single-agent SOT102 expansion at RP2D identified in Part A in pancreatic cancer after one or more prior systemic therapies (second+ line) for locally advanced or metastatic disease (CLDN18.2 positive) - Part D gastric cohort: SOT102 in combination with mFOLFOX6 and nivolumab expansion at RP2D identified in Part B for first-line treatment in gastric/GEJ cancer (CLDN18.2 positive) - Part D pancreatic cohort: SOT102 in combination with nab- paclitaxel/gemcitabine for first-line treatment expansion at RP2D identified in Part B in pancreatic cancer (CLDN18.2 positive) ;
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