A Study of Mipasetamab Uzoptirine (ADCT-601) in Participants With Solid Tumors

Stopped early · Phase 1

Conditions studied: Advanced Solid Tumors

In brief

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.

Key facts

Study ID

NCT05389462

Run by

ADC Therapeutics S.A.

People needed

128

Starts

2022-07-13

Expected to finish

2025-04-17

Last updated by the study team

2025-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female participant aged 18 years or older.
• Pathologic diagnosis of solid tumor malignancy that is locally advanced or metastatic at time of screening:
• Part 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.
• 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:
• Combination therapy arms: Sarcoma indications and PAAD.
• Monotherapy arms: PAAD, NSCLC and solid tumors with AXL expression.
• Participants who are refractory to or intolerant to available standard therapy(ies) known to provide clinical benefit for their condition per Investigator judgment.
• Participants with measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.
• PAAD only: Royal Marsden Hospital Prognostic Score 0 - 1.

You may not qualify if…

• History of recent infection requiring intravenous (IV) antibiotics, IV antiviral, or IV antifungal treatment within 4 weeks of Cycle 1 Day 1 (C1D1).
• 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.
• 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).
• 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).
• Use of any other experimental medication within 14 days prior to start of study drug (C1D1).

Where it is running

• Sarcoma Oncology Research Center — Santa Monica, California, United States
• Stanford Cancer Center, Stanford Medicine at Stanford University — Stanford, California, United States
• University of IOWA — Iowa City, Iowa, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Sarah Cannon at University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Vanderbilt University Medical Center (VUMC) - Ingram Cancer Center — Nashville, Tennessee, United States
• Institut Bergonié — Bordeaux, Gironde, France
• Institut Léon Bérard — Lyon, France
• Centre Antoine Lacassagne — Nice, France
• Hospital Universitario Vall d'Hebron — Barcelona, Spain
• Hospital Universitario Fundacion Jimenez Diaz — Madrid, Spain
• Hospital Universitario Madrid Sanchinarro — Madrid, Spain
• The Royal Marsden NHS Foundation Trust — London, England, United Kingdom
• The Christie NHS Foundation Trust — Manchester, England, United Kingdom

Full record on ClinicalTrials.gov

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