Phase
Condition
Neoplasms
Treatment
ADCT-601
Gemcitabine
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female participant aged 18 years or older.
Pathologic diagnosis of solid tumor malignancy that is locally advanced ormetastatic at time of screening: Part 1:
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.
- 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:
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 Criteriain Solid Tumors (RECIST) v1.1.
Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.
PAAD only: Royal Marsden Hospital Prognostic Score 0 - 1.
Exclusion
Exclusion Criteria:
History of recent infection requiring intravenous (IV) antibiotics, IV antiviral, orIV antifungal treatment within 4 weeks of Cycle 1 Day 1 (C1D1).
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.
Clinically significant third space fluid accumulation (i.e., ascites requiringdrainage or any serosal effusion that is either requiring drainage or associatedwith shortness of breath).
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).
Use of any other experimental medication within 14 days prior to start of study drug (C1D1).
Study Design
Connect with a study center
Institut Bergonié
Bordeaux, Gironde 33076
FranceSite Not Available
Institut Léon Bérard
Lyon, 69008
FranceSite Not Available
Centre Antoine Lacassagne
Nice, 06189
FranceSite Not Available
Hospital Universitario Vall d'Hebron
Barcelona, 08035
SpainSite Not Available
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040
SpainSite Not Available
Hospital Universitario Madrid Sanchinarro
Madrid, 28050
SpainSite Not Available
The Royal Marsden NHS Foundation Trust
London, England SW3 6JJ
United KingdomSite Not Available
The Christie NHS Foundation Trust
Manchester, England M20 4BX
United KingdomSite Not Available
Sarcoma Oncology Research Center
Santa Monica, California 90403
United StatesSite Not Available
Stanford Cancer Center, Stanford Medicine at Stanford University
Stanford, California 94305
United StatesSite Not Available
University of IOWA
Iowa City, Iowa 52242
United StatesSite Not Available
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
Sarah Cannon at University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 78229
United StatesSite Not Available
Vanderbilt University Medical Center (VUMC) - Ingram Cancer Center
Nashville, Tennessee 37232
United StatesSite Not Available
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