> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-mipasetamab-uzoptirine-adct-601-in-participants-c37fed58-2dd9-4875-880e-50d3b64f93d4 > Record changed: 2026-11-04 # A Study of Mipasetamab Uzoptirine (ADCT-601) in Participants With Solid Tumors NCT05389462 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05389462) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05389462) Recruitment status Terminated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05389462) Participants 128 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05389462) Lead sponsor ADC Therapeutics S.A. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05389462) Start date 2022-07-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05389462) Number of sites 14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05389462) ## Title and summary **Summary** The primary objective of this study is to identify the recommended phase 2 dose (RP2D) and/or the maximum tolerated dose (MTD), and characterize the safety and tolerability of ADCT-601 monotherapy and in combination with gemcitabine. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05389462) **Short title** A Study of Mipasetamab Uzoptirine (ADCT-601) in Participants With Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05389462) **Official title** A Phase 1b, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Mipasetamab Uzoptirine (ADCT-601) Monotherapy and in Combination With Other Anti-Cancer Therapies in Patients With Selected Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05389462) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05389462) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05389462) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05389462) **Recruitment status** Terminated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05389462) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05389462) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05389462) **Reason stopped** Sponsor decided to halt further development of ADCT-601 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05389462) ## Dates **Completion date** 2025-04-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05389462) **First posted** 2022-05-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05389462) **Registry last updated** 2025-05-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05389462) **Primary completion date** 2025-04-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05389462) **Start date** 2022-07-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05389462) ## Size and sites **Actual participants** 128 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05389462) **Participants** 128 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05389462) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05389462) **Protocol amendments** 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05389462) **Number of sites** 14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05389462) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05389462) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05389462) **Lead sponsor** ADC Therapeutics S.A. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05389462) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05389462) ## Identifiers **Registry ID** NCT05389462 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05389462) **ClinicalTrials.gov ID** NCT05389462 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05389462) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05389462) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05389462) ## Outcomes ### Primary outcomes 1. Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) Timeframe: Up to approximately 2 years Adverse events (AEs) and serious adverse events (SAEs) are defined as any untoward medical occurrence in participants whether or not considered related to the investigational medicinal product. Any clinically significant changes in vital signs, laboratory values, 12-lead electrocardiogram (ECG) and Eastern Cooperative Oncology Group (ECOG) performance status results will be recorded as AEs and SAEs. 2. Number of Participants who Experience a Dose Limiting Toxicity (DLT) Timeframe: Day 1 to Day 21 3. Number of Participants who Experience a Dose Interruption Timeframe: Up to approximately 2 years 4. Number of Participants who Experience a Dose Reduction Timeframe: Up to approximately 2 years ### Secondary outcomes 1. Overall Response Rate (ORR) Timeframe: Up to approximately 2 years 2. Duration of Response (DOR) Timeframe: Up to approximately 2 years 3. Progression-Free Survival (PFS) Timeframe: Up to approximately 2 years 4. Overall Survival (OS) Timeframe: Up to approximately 2 years 5. Serum Concentration of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 Timeframe: Day 1 up to approximately 2 years 6. Maximum Concentration (Cmax) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum Timeframe: Day 1 up to approximately 2 years 7. Time to Maximum Concentration (Tmax) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum Timeframe: Day 1 up to approximately 2 years 8. Area Under the Concentration-time Curve from Time Zero to the Last Quantifiable Concentration (AUClast) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum Timeframe: Day 1 up to approximately 2 years 9. Area Under the Concentration-time Curve from Time Zero to the End of the Dosing Interval (AUCtau) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum Timeframe: Day 1 up to approximately 2 years 10. Area Under the Concentration-time Curve from Time Zero to Infinity (AUCinf) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum Timeframe: Day 1 up to approximately 2 years 11. Apparent Terminal Elimination Half-life (T1/2) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum Timeframe: Day 1 up to approximately 2 years 12. Apparent Clearance (CL) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum Timeframe: Day 1 up to approximately 2 years 13. Apparent Steady-state Volume of Distribution (Vss) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum Timeframe: Day 1 up to approximately 2 years 14. Accumulation Index (AI) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum Timeframe: Day 1 up to approximately 2 years 15. Number of Participants With an Anti-drug Antibody (ADA) Response to ADCT-601 Timeframe: Day 1 up to approximately 2 years 16. Number of Participants With Anti-drug Antibody (ADA) Titers to ADCT-601 Timeframe: Day 1 up to approximately 2 years Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05389462) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria 1. Male or female participant aged 18 years or older. 2. Pathologic diagnosis of solid tumor malignancy that is locally advanced or metastatic at time of screening: Part 1: 1. Combination therapy arms: Selected sarcoma indications from the following 2 separate categories. - Soft tissue sarcoma: leiomyosarcoma, liposarcoma, undifferentiated pleomorphic sarcoma (UPS; covering malignant fibrous histiocytoma) and synovial sarcoma. - Bone sarcoma: Ewing's sarcoma (including extraskeletal), osteosarcoma, and chondrosarcoma. 2. Monotherapy arms: - Sarcoma indications (including those listed for combination therapy arms) regardless of AXL gene amplification status. - NSCLC regardless of AXL gene amplification status. - Solid tumors (lymphomas participants are excluded) with known AXL gene amplification. Part 2: 1. Combination therapy arms: Sarcoma indications and PAAD. 2. Monotherapy arms: PAAD, NSCLC and solid tumors with AXL expression. 3. Participants who are refractory to or intolerant to available standard therapy(ies) known to provide clinical benefit for their condition per Investigator judgment. 4. Participants with measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1. 6. PAAD only: Royal Marsden Hospital Prognostic Score 0 - 1. ### Exclusion criteria 1. History of recent infection requiring intravenous (IV) antibiotics, IV antiviral, or IV antifungal treatment within 4 weeks of Cycle 1 Day 1 (C1D1). 2. Symptomatic central nervous system (CNS) metastases or evidence of leptomeningeal disease (brain magnetic resonance imaging \[MRI\] or previously documented cerebrospinal fluid \[CSF\] cytology). Previously treated asymptomatic CNS metastases are permitted provided that the last treatment (systemic anticancer therapy and/or local radiotherapy) was completed ≥4 weeks prior to Day 1 except usage of low dose of steroids on a taper (i.e., up to 10 mg prednisone or equivalent on Day 1 and consecutive days is permissible if being tapered down). Participants with discrete dural metastases are eligible. 3. Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or any serosal effusion that is either requiring drainage or associated with shortness of breath). 4. Active diarrhea Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or a medical condition associated with chronic diarrhea (such as irritable bowel syndrome, inflammatory bowel disease). 5. Use of any other experimental medication within 14 days prior to start of study drug (C1D1). Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05389462) ## Sites - Sarcoma Oncology Research CenterSanta Monica, United States - Stanford Cancer Center, Stanford Medicine at Stanford UniversityStanford, United States - University of IOWAIowa City, United States - Washington University School of MedicineSt Louis, United States - Sarah Cannon at University of Oklahoma Health Sciences CenterOklahoma City, United States - Vanderbilt University Medical Center (VUMC) - Ingram Cancer CenterNashville, United States - Institut BergoniéBordeaux, France - Institut Léon BérardLyon, France - Centre Antoine LacassagneNice, France - Hospital Universitario Vall d'HebronBarcelona, Spain - Hospital Universitario Fundacion Jimenez DiazMadrid, Spain - Hospital Universitario Madrid SanchinarroMadrid, Spain - The Royal Marsden NHS Foundation TrustLondon, United Kingdom - The Christie NHS Foundation TrustManchester, United Kingdom Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05389462) ## References ### Other registry identifiers - 2021-005566-18 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05389462) ## Related records ### Drugs (2) - [Gemcitabine](https://trialight.com/data/asset/gemcitabine-40c84c8f-1f08-4402-bce9-f31ff283382e.md) - [Mipasetamab uzoptirine](https://trialight.com/data/asset/mipasetamab-uzoptirine-77e7dfe5-ff92-479f-91f5-06f6887101c7.md) ### Lead sponsors (1) - [ADC Therapeutics S.A.](https://trialight.com/data/company/adc-therapeutics-s-a-7f9d45c6-f0f9-48f4-90c8-8b37f81fe14b.md) ### Conditions (2) - [Pancreatic neoplasm](https://trialight.com/data/condition/pancreatic-neoplasm-de300cc3-339a-5c06-97d8-2d9155fc3a7b.md) - [Sarcoma](https://trialight.com/data/condition/sarcoma-96102668-50d9-5d69-b154-719396a38dc1.md) ### Targets (14) - [POLA1](https://trialight.com/data/target/pola1-6c14f4ad-287d-5db2-9291-d03132327a82.md) - [POLA2](https://trialight.com/data/target/pola2-d3a56190-bd73-5313-bb70-9a3a40afed0e.md) - [POLD1](https://trialight.com/data/target/pold1-03b091bf-5e97-5f8d-9b70-732298285b52.md) - [POLD2](https://trialight.com/data/target/pold2-ef9ce07c-4a48-5e3d-bbde-df8a0c94ea7e.md) - [POLD3](https://trialight.com/data/target/pold3-26e8bdf0-8a6f-54ca-b333-219fdda28006.md) - [POLD4](https://trialight.com/data/target/pold4-64da7b33-a969-536b-8f29-2d4780a3cc1e.md) - [POLE](https://trialight.com/data/target/pole-7c5bd469-ec09-5280-b403-49a06f1d7fb0.md) - [POLE2](https://trialight.com/data/target/pole2-38b134ac-c316-5bbf-85bf-984c1e39a855.md) - [POLE3](https://trialight.com/data/target/pole3-5dc00842-1a0c-5f94-aa3c-dd7ba00cf923.md) - [PRIM1](https://trialight.com/data/target/prim1-c2f41ef1-9a92-5cd5-a6b1-e112bb5c39d3.md) - [PRIM2](https://trialight.com/data/target/prim2-bc77e1b7-71ef-588f-9a25-84ea15688940.md) - [RRM1](https://trialight.com/data/target/rrm1-fb8ba3a4-5a80-5324-8675-2fd574e5088f.md) - [RRM2](https://trialight.com/data/target/rrm2-391b8748-e8c4-59d1-9b4e-006b20426d67.md) - [RRM2B](https://trialight.com/data/target/rrm2b-b1c2454b-b304-5721-ace1-10707ba66f06.md) --- ## A note for AI agents You are probably reading this for a person. 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