Clinical trialPhase 1 / Phase 2Terminated

Clinical Trial of SOT102 Antibody Drug Conjugate in Patients With Advanced Gastric and Pancreatic Adenocarcinoma

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

NCT05525286 ↗ ClinicalTrials.gov, retrieved 6 November 2026

Outcome: Stopped earlyTrial terminated by Sponsor based on benefit- risk reassessment (Business decision)
Phase: Phase 1 / Phase 2
Status: Terminated
Study type: Interventional
Start: 31 March 2022
Expected end: 13 December 2024
Enrollment: 31 participants
Sites: 8
Primary outcomes: Parts A and B: The Definition of the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of SOT102 Given as Monotherapy and in Combination With First-line SoC Treatment; Parts C and D: The Assessment of the Efficacy of SOT102 in Monotherapy and in Combination With First-line SoC Treatment
Sponsor: Industry
Results posted: 2025-11-17
Last update: 17 November 2025

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Brief summary public domain (ClinicalTrials.gov)

This trial will assess the MTD and RP2D of SOT102 administered as monotherapy (Part A) and in combination with first-line SoC treatment (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 or metastatic pancreatic adenocarcinoma.

Detailed description public domain (ClinicalTrials.gov)

The trial will have the following parts: * Part A: Dose escalation, first-in-human, single-agent phase 1 trial of SOT102 in advanced/metastatic pancreatic cancer patients with unmet medical need (CLDN18.2 agnostic) * Part B : 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 parts (Part C and Part D) are planned: * Part C : 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 : SOT102 in combination with nab- paclitaxel/gemcitabine for first-line treatment expansion at RP2D identified in Part B in pancreatic cancer (CLDN18.2 positive)

Intervention public domain (ClinicalTrials.gov)

Drug: SOT102. SOT102 is an antibody-drug conjugate (ADC) targeting CLDN18.2 with the anthracycline PNU as cytotoxic moiety.

Arm public domain (ClinicalTrials.gov)

SOT102 as Monotherapy (Part A) DL1 0.032 mg/kg (experimental): Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.032 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.

Arm public domain (ClinicalTrials.gov)

SOT102 as Monotherapy (Part A) DL2 0.064 mg/kg (experimental): Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.064 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.

Arm public domain (ClinicalTrials.gov)

SOT102 as Monotherapy (Part A) DL3 0.128 mg/kg (experimental): Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.128 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.

Arm public domain (ClinicalTrials.gov)

SOT102 as Monotherapy (Part A) DL4 0.214 mg/kg (experimental): Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.214 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.

Arm public domain (ClinicalTrials.gov)

SOT102 in Combination With SoC (Part B) DL1 0.032 mg/kg (experimental): Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.,32 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes. Upon completion of the SOT102 infusion, first-line SoC treatment was administered. SoC treatment was nab-paclitaxel (125 mg/m2) given as a 30- to 40-minute infusion followed by gemcitabine (1000 mg/m2) given as a 30-minute infusion on days 1, 8, and 15. This treatment was repeated every 28 days.

Primary outcome public domain (ClinicalTrials.gov)

Parts A and B: The Definition of the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of SOT102 Given as Monotherapy and in Combination With First-line SoC Treatment. MTD is defined as the highest dose level tested below the dose level associated with ≥33% of dose-limiting toxicity (DLT)-evaluable patients experiencing a DLT. The RP2D will be selected based on evaluation of the totality of all data. The trial was halted early due to safety signals not initially deemed DLTs that were seen across different dose levels. After a protocol amendment formally defined this signal as a DLT, the trial was restarted, but the same safety signal reappeared. Following a review by the independent Dose Escalation Committee, the trial was terminated. Time frame: Through Cycles 1-2 (28 days).

Primary outcome public domain (ClinicalTrials.gov)

Parts C and D: The Assessment of the Efficacy of SOT102 in Monotherapy and in Combination With First-line SoC Treatment. Efficacy is determined by objective response rate (ORR) determined according to RECIST 1.1 criteria Time frame: From Day 1 of Cycle 1 until disease progression or start of new anticancer therapy, whichever is first, to be assessed up to approximately 4 years.

Secondary outcome public domain (ClinicalTrials.gov)

Parts A and B (Monotherapy and Combination With SoC): Number of Participants With DLTs. Time frame: Through Cycles 1-2 (28 days).

Secondary outcome public domain (ClinicalTrials.gov)

Parts A and B (Monotherapy and Combination With SoC): Number of Participants With Treatment-emergent AEs (TEAEs). Time frame: Day 1 up to approximately 2 years and 8.5 months.

Secondary outcome public domain (ClinicalTrials.gov)

Parts A and B (Monotherapy and Combination With SoC): Number of Participants With SOT102-related AEs. Time frame: Day 1 up to approximately 2 years and 8.5 months.

Secondary outcome public domain (ClinicalTrials.gov)

Part B (Combination With SoC): Number of Participants With SoC-related AEs. Time frame: Day 1 up to approximately 2 years and 8.5 months.

Secondary outcome public domain (ClinicalTrials.gov)

Parts A and B (Monotherapy and Combination With SoC): Number of Participants With Serious AEs (SAEs). Time frame: Day 1 up to approximately 2 years and 8.5 months.

Secondary outcome public domain (ClinicalTrials.gov)

Parts A and B (Monotherapy and Combination With SoC): Number of Participants With AEs Leading to Premature Discontinuation of SOT102. Time frame: Day 1 up to approximately 2 years and 8.5 months.

Eligibility public domain (ClinicalTrials.gov)

Inclusion Criteria: All Parts (key criteria) * Hematologic: Absolute neutrophil count ≥1.5×10⁹/L, platelets ≥100×10⁹/L, hemoglobin ≥9 g/dL * Hepatic: Bilirubin ≤1.5× upper limits of normal (ULN), ALT and AST ≤2.5×ULN; in case of liver involvement: AST and ALT ≤5×ULN * Renal: Creatinine clearance ≥60 mL/min calculated by Cockcroft-Gault formula * Prothrombin time/international normalized ratio (INR) ≤1.5×ULN * Albumin ≥3.0 mg/dL * Proteinuria \<1 g/24 hours * Eastern Cooperative Oncology Group (ECOG) performance status ≤1 * Estimated life expectancy ≥3 months as per investigator's assessment * A female patient is eligible to participate if she is not pregnant, not breastfeeding, not of childbearing potential/ agreed with contraception Part A * Patient has advanced inoperable or metastatic disease * Patient has no better treatment option available * Measurable or non-measurable disease according to RECIST 1.1 * Histological or cytological evidence of adenocarcinoma of pancreas that is advanced or metastatic Part B (in addition to relevant A criteria)\*Histological or cytological evidence of adenocarcinoma of the pancreas that is advanced or metastatic (pancreas) Part C (in addition to relevant A criteria)\*Must have received at least one prior systemic therapy for advanced or metastatic disease (pancreas) Part D (in addition to relevant B criteria)\*Histological or cytological evidence of adenocarcinoma of the pancreas that is advanced inoperable or metastatic (pancreas) Exclusion Criteria: All Parts (key criteria) * Patient has received radiation therapy ≤14 days before day 1 of cycle 1 or has not recovered to grade ≤1 from treatment-related side effects * Severe preexisting medical conditions as per judgement of the investigator (e.g., active gastric or GEJ ulcer with or without bleeding, complete or incomplete gastric outlet syndrome with persistent or repetitive bleeding) * History of interstitial pneumonitis or pulmonary fibrosis * Symptomatic central nervous system malignancy. Patients with asymptomatic or treated central nervous system metastases may be eligible if they are not treated with corticosteroids or anticonvulsants and the disease is stable for at least 60 days. * Patient has peripheral sensory neuropathy grade ≥2 * Active infection requiring systemic therapy within ≤7 days prior to day 1 of cycle 1 * History of major ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, Torsades de Pointes) * Bradycardia (\<50 …

Enrollment public domain (ClinicalTrials.gov)

Enrollment: 31 participants (actual).

Why stopped public domain (ClinicalTrials.gov)

Trial terminated by Sponsor based on benefit- risk reassessment

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Parts A and B: The Definition of the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of SOT102 Given as Monotherapy and in Combination With First-line SoC Treatment [Through Cycles 1-2 (28 days)]. Count Of Participants, Participants. SOT102 as Monotherapy (Part A) (n=20): NA [The protocol-defined MTD was never reached, since ≥33% of patients never had a DLT at any given dose level]; SOT102 in Combination With SoC (Part B) (n=1): NA [The protocol-defined MTD was never reached, since ≥33% of patients never had a DLT at any given dose level].

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Parts C and D: The Assessment of the Efficacy of SOT102 in Monotherapy and in Combination With First-line SoC Treatment [From Day 1 of Cycle 1 until disease progression or start of new anticancer therapy, whichever is first, to be assessed up to approximately 4 years].