A Dose-Escalation and Dose-Expansion Study of Mipasetamab Uzoptirine (ADCT-601) in Participants With Solid Tumors
A Dose-Escalation and Dose-Expansion Study of Mipasetamab Uzoptirine (ADCT-601) in Participants With Solid Tumors
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.
(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.
Miscellaneous
Phase I
Both
Chemotherapy - cytotoxic,
Mol. targeted/Immunotherapy/Biologics
ADCT-601,
Gemcitabine
Davis, Elizabeth
International
Vanderbilt University
11-15-2022
Treatment
VICCPHI2225
NCT05389462
Eligibility
18 Years
BOTH
NO
Inclusion Criteria:
Pathologic diagnosis of solid tumor malignancy that is locally advanced or metastatic at time of screening:
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: For Dose Escalation:
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.
For Dose Expansion: participants with known AXL gene amplification with sarcoma (any sarcoma indications, except those listed in combination therapy arms), ovarian/fallopian tube cancer/primary peritoneal cancer, pancreatic cancer, bladder cancer, cervical cancer, or endometrial cancer.
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 nave
Group 2: participants must have received prior gemcitabine containing regimen
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.
Exclusion Criteria:
History of recent infection requiring intravenous (IV) antibiotics, IV antiviral, or IV antifungal treatment within 4 weeks of Cycle 1 Day 1 (C1D1).
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.
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).
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).
Use of any other experimental medication within 14 days prior to start of study drug (C1D1).
Pathologic diagnosis of solid tumor malignancy that is locally advanced or metastatic at time of screening:
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: For Dose Escalation:
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.
For Dose Expansion: participants with known AXL gene amplification with sarcoma (any sarcoma indications, except those listed in combination therapy arms), ovarian/fallopian tube cancer/primary peritoneal cancer, pancreatic cancer, bladder cancer, cervical cancer, or endometrial cancer.
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 nave
Group 2: participants must have received prior gemcitabine containing regimen
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.
Exclusion Criteria:
History of recent infection requiring intravenous (IV) antibiotics, IV antiviral, or IV antifungal treatment within 4 weeks of Cycle 1 Day 1 (C1D1).
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.
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).
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).
Use of any other experimental medication within 14 days prior to start of study drug (C1D1).
