Status:
TERMINATED
A Study of Mipasetamab Uzoptirine (ADCT-601) in Participants With Solid Tumors
Lead Sponsor:
ADC Therapeutics S.A.
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
July 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 17 2025
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT05389462
Start Date
July 13 2022
End Date
April 17 2025
Last Update
May 22 2025
Active Locations (14)
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1
Sarcoma Oncology Research Center
Santa Monica, California, United States, 90403
2
Stanford Cancer Center, Stanford Medicine at Stanford University
Stanford, California, United States, 94305
3
University of IOWA
Iowa City, Iowa, United States, 52242
4
Washington University School of Medicine
St Louis, Missouri, United States, 63110