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

Last updated: May 19, 2025
Sponsor: ADC Therapeutics S.A.
Overall Status: Terminated

Phase

1

Condition

Neoplasms

Treatment

ADCT-601

Gemcitabine

Clinical Study ID

NCT05389462
ADCT-601-102
2021-005566-18
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female participant aged 18 years or older.

  2. Pathologic diagnosis of solid tumor malignancy that is locally advanced ormetastatic at time of screening: Part 1:

  3. Combination therapy arms: Selected sarcoma indications from the following 2separate categories.

  • Soft tissue sarcoma: leiomyosarcoma, liposarcoma, undifferentiatedpleomorphic sarcoma (UPS; covering malignant fibrous histiocytoma) andsynovial sarcoma.
  • Bone sarcoma: Ewing's sarcoma (including extraskeletal), osteosarcoma, andchondrosarcoma.
  1. 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 geneamplification. 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 Criteriain 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

Exclusion Criteria:

  1. History of recent infection requiring intravenous (IV) antibiotics, IV antiviral, orIV antifungal treatment within 4 weeks of Cycle 1 Day 1 (C1D1).

  2. Symptomatic central nervous system (CNS) metastases or evidence of leptomeningealdisease (brain magnetic resonance imaging [MRI] or previously documentedcerebrospinal fluid [CSF] cytology). Previously treated asymptomatic CNS metastasesare permitted provided that the last treatment (systemic anticancer therapy and/orlocal radiotherapy) was completed ≥4 weeks prior to Day 1 except usage of low doseof steroids on a taper (i.e., up to 10 mg prednisone or equivalent on Day 1 andconsecutive days is permissible if being tapered down). Participants with discretedural metastases are eligible.

  3. Clinically significant third space fluid accumulation (i.e., ascites requiringdrainage or any serosal effusion that is either requiring drainage or associatedwith shortness of breath).

  4. Active diarrhea Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or amedical condition associated with chronic diarrhea (such as irritable bowelsyndrome, inflammatory bowel disease).

  5. Use of any other experimental medication within 14 days prior to start of study drug (C1D1).

Study Design

Total Participants: 128
Treatment Group(s): 2
Primary Treatment: ADCT-601
Phase: 1
Study Start date:
July 13, 2022
Estimated Completion Date:
April 17, 2025

Connect with a study center

  • Institut Bergonié

    Bordeaux, Gironde 33076
    France

    Site Not Available

  • Institut Léon Bérard

    Lyon, 69008
    France

    Site Not Available

  • Centre Antoine Lacassagne

    Nice, 06189
    France

    Site Not Available

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario Madrid Sanchinarro

    Madrid, 28050
    Spain

    Site Not Available

  • The Royal Marsden NHS Foundation Trust

    London, England SW3 6JJ
    United Kingdom

    Site Not Available

  • The Christie NHS Foundation Trust

    Manchester, England M20 4BX
    United Kingdom

    Site Not Available

  • Sarcoma Oncology Research Center

    Santa Monica, California 90403
    United States

    Site Not Available

  • Stanford Cancer Center, Stanford Medicine at Stanford University

    Stanford, California 94305
    United States

    Site Not Available

  • University of IOWA

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Sarah Cannon at University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma 78229
    United States

    Site Not Available

  • Vanderbilt University Medical Center (VUMC) - Ingram Cancer Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

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