Status and phase
Conditions
Treatments
About
This study is an open-label, Phase 1, multicenter, continuous dose escalation study of XT-0528 in adult subjects with Advanced or Metastatic Solid Tumor Malignancies.
The study will consist of 4 periods:
Screening Period (up to 28 days prior to Cycle 1 Day 1) Safety Run-in Period (Cycle 1; continuous dosing on Days 1-21 of 28-day cycle) Continuous Dosing Period (Cycle 2 and beyond; continuous dosing on Days 1-28 of 28-day cycle) Safety Follow-up Period (30 days post-last dose).
Full description
Primary Objective
Secondary Objective
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Subject must be ≥18 years of age at the time of consent;
Able to understand the key components of the study as described in the written informed consent document, and willing and able to provide written informed consent;
In the opinion of the Investigator, is able to adhere to the requirements of the study;
Willing and able to comply with the contraceptive requirements of the study:
Subject must have histologically confirmed solid tumor malignancy that is metastatic or unresectable and have no additional approved standard of care treatment options, in the opinion of the Investigator;
Subject must have at least one biopsy accessible tumor;
Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2;
Subject must have an anticipated life expectancy >3 months;
Subject must have normal organ and bone marrow function within 14 days of initiating study drug as defined below:
Subjects must have resolution (Grade ≤1 or returned to baseline) of toxic effect(s) of the most recent prior therapy except:
Subjects who received major surgery or radiation therapy of >30 Gy, must have recovered from the toxicity and/or complications from the intervention.
Exclusion criteria
Received other recent antitumor therapy including:
Subject is expected to require any other form of antineoplastic therapy while on study;
Subject with active autoimmune disease requiring disease modifying therapy;
Subject has known history of prior malignancy except subjects who have undergone potentially curative therapy with no evidence of that disease recurrence within 5 years of therapy initiation. Allowable active malignancies include basal cell carcinoma, squamous cell (skin) carcinoma, or indolent lymphoma/leukemia not requiring treatment.
Subject requiring concurrent systemic corticosteroid therapy >10 mg/day of prednisone;
Subject with known active hepatitis B/C infection (positive viral titers) that has not been treated;
Subjects with known uncontrolled Human Immunodeficiency Virus (HIV)/Acquired Immunodeficiency Syndrome (AIDS) on anti-retroviral therapy defined by a cluster of differentiation 4 (CD4) count <200;
Subject has known central nervous system, meningeal, or epidural disease. Subjects with stable brain metastases for at least 4 weeks following definitive local treatment without new or enlarging brain metastases are eligible if corticosteroid requirement is ≤7.5 mg/day of prednisone (or equivalent);
Subject with a known history of significant cardiovascular disease as evidence by New York Heart Association (NYHA) classification Stage III/IV heart failure, unstable angina, myocardial infarction within the past 6 months, or uncontrolled arrhythmias;
Subjects has known history of corrected QT Interval (QTc) prolongation or observed QTc prolongation >470 ms during screening ECG;
Subject with known history of gastrointestinal (GI) disease that could affect drug absorption (eg, malabsorptive disorders, inflammatory bowel disease, short bowel from significant bowel resection, intestinal obstruction for peritoneal carcinomatosis);
Subject with known history or presence of allergic or adverse response to XT-0528 or related drugs or its excipients;
Subject requires use of strong inhibitors, strong inducers, and sensitive substrates of major cytochrome P450 enzymes (CYP) and drug transporters.
Subjects requiring chronic use of acid reducing agents (ARAs) are excluded from the study unless able to suspend use of ARAs for 48 hours prior to PK sampling days
Subject is pregnant, plans to become pregnant, breastfeeding, or expecting to conceive or father a child within the projected duration of study participation;
Subject has known psychiatric or substance abuse disorder(s) that would interfere with cooperation with required elements of study participation.
Primary purpose
Allocation
Interventional model
Masking
30 participants in 5 patient groups
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Central trial contact
Lynne Kelley, MD; Sherry L Plantholt, BS
Data sourced from clinicaltrials.gov
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