A Dose-Escalation and Dose-Expansion Study of Mipasetamab Uzoptirine (ADCT-601) in Participants With Solid Tumors

• Status: Not yet recruiting
• Trial end date: 2027-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to identify the recommended dose for expansion (RDE) (and recommended schedule) and/or the maximum tolerated dose (MTD), and characterize the safety and tolerability of ADCT-601 monotherapy and in combination with gemcitabine.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ADC Therapeutics S.A.
• Treatments: Gemcitabine

Criteria

Inclusion Criteria:

1. Pathologic diagnosis of solid tumor malignancy that is locally advanced or metastatic at time of screening:

1. Selected sarcoma indications from the following 2 separate categories

• Soft tissue sarcoma: leiomyosarcoma, liposarcoma, undifferentiated pleomorphic sarcoma (UPS) and synovial sarcoma.

• Bone sarcoma: Ewing's sarcoma, osteosarcoma and chondrosarcoma

2. Participants with AXL gene alteration, with sarcoma (any sarcoma indications, except those listed in ADCT-601 combination therapy arms), ovarian/fallopian tube cancer/primary peritoneal cancer, pancreatic cancer, bladder cancer, cervical cancer, or endometrial cancer.

2. Participants who are refractory to or intolerant to available standard therapy(ies) known to provide clinical benefit for their condition per Investigator judgment.

• In Dose Expansion (Part 2) ADCT-601 combination therapy arm:

• Group 1: participants must be gemcitabine naïve

• Group 2 participants must have received prior gemcitabine containing regimen

3. Participants with measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

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).