Education and Training
A Study of Mipasetamab Uzoptirine (ADCT-601) in Participants With Solid Tumors
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.
Stanford is currently accepting patients for this trial.
Intervention(s):
- drug: ADCT-601
- drug: Gemcitabine
Eligibility
Inclusion Criteria:
1. Male or female participant aged 18 years or older.
2. Pathologic diagnosis of solid tumor malignancy that is locally advanced or metastatic
at time of screening:
Part 1:
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.
2. 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:
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 Criteria in
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 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).
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Feriel Buchholz
650-721-4090
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