A Phase Ib, 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

Study Identifier:
ADCT-601-102
CT.gov Identifier:
NCT05389462
EudraCT Identifier:
2021-005566-18
EU Trial (CTIS) Number:
2022-500116-18-00
Study Contact Information:
(210) 593-5651 or [email protected]
Terminated/Withdrawn

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Study Summary

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.

Initial IHC staining showed AXL expression in all sarcoma baseline biopsies tested so far.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Solid Tumor
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
Female & Male
Age
18+ years
Study Drug
Drug: Experimental: Part 1: Dose Escalation, ADCT-601 Monotherapy
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Drug: Participants will be split into 3 cohorts:
Drug: Cohorts 5 and 6: Sarcoma indications.
Drug: Cohort 7: Pancreatic cancer.
Drug: Drug: ADCT-601
Drug: Experimental: Part 2: Dose Expansion, ADCT-601 Monotherapy
Drug: Participants will be split into cohorts:
Drug: Cohort 1: Soft tissue sarcoma (STS).
Drug: Cohort 2: Pancreatic adenocarcinoma (PAAD).
Drug: Cohort 3: NSCLC.
Drug: Cohort 4: Solid tumors with known AXL expression.
Study Status
Indicates the current recruitment status or the expanded access status
Terminated/Withdrawn

Requirements information
Inclusion criteria
  • 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 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).

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Madrid, Spain (CIOCC)
Madrid, Spain, 28050
Investigator
Maria de Miguel
Status
Terminated/Withdrawn
Condition(s) Treated at Site
Solid Tumor