Phase
Condition
Neoplasm Metastasis
Treatment
KB-GDT-01
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Signed and dated informed consent form.
Male or female, > 18 years old.
Minimum body weight of 50 kilograms (kg).
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Histologically or cytologically confirmed locally advanced or metastatic NSCLC orlocally advanced or metastatic solid tumor with bone metastasis
Progressed on SOC therapy including platinum-based chemotherapy and immunecheckpoint inhibitors (NSCLC), and are not a candidate for further standardanti-neoplastic therapy and/or have exhibited intolerance to and/or declinedclinically applicable salvage therapies, and/or have declined therapy.
Genomic screening, with tumors with known actionable molecular alterations, such asEGFR, ALK, ROS-1, BRAF, RET, MET, and KRAS etc., must have progressed on appropriatetarget-directed molecular therapy.
At least one measurable target lesion based on RECIST v1.1 confirmed by radiologicalimaging. Participants with isolated bone metastases are eligible for enrollment arenot required to have measurable disease
All toxicity associated with previous treatments are recovered to CTCAE grade of ≤1,except for continuing alopecia.
Adequate hematopoietic, hepatic and renal function
Agree to adequate contraception for up to 120 days after the last dose of studydrug.
Negative serum pregnancy test for women of childbearing potential
All primary and metastatic disease sites are amenable to LDRT
For solid tumors with bone metastases subjects (Part 2 Cohort B): receivingzoledronic acid for solid tumors with bone metastases
Exclusion
Exclusion Criteria:
Chemotherapy, investigational, and/or check-point inhibitor therapy within the 30days prior to study Day 1.
Major surgery, except for vascular access placement, within the 30 days prior tostudy Day 1.
Active autoimmune disease requiring immunosuppressive therapy.
Infection requiring systemic treatment within 30 days prior to study Day 1.
History of peritoneal effusion (ascites), pericardial, or pleural effusions/nodules.
Uncontrolled hypertension, history of arrhythmia including atrial fibrillation,unstable angina, decompensated congestive heart failure, cardiac ejection fraction ≤ 50%, myocardial infarction, or marked baseline prolonged QT/QTc intervals.
Human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C detection.
Participation in the treatment portion of a clinical trial or completed a clinicaltrial within the 30 days prior to the first dose of KB-GDT-01.
Presence of any condition that may, in the opinion of the Investigator, render thepatient inappropriate from participating in the study.
Breastfeeding or pregnant female, or patient is expecting to conceive or fatherchildren during the study.
Allergy or intolerance to any of the study product ingredients or excipients.
Live vaccines administered within 30 days prior to study Day 1.
Individuals lacking capacity to consent for themselves.
Superior vena cava obstruction
Prior radiation therapy to a selected LDRT treatment site </= 30 days prior to Day
Study Design
Study Description
Connect with a study center
The University of Arizona Cancer Center
Tucson, Arizona 85719
United StatesSite Not Available
Beverly Hills Cancer Center
Beverly Hills, California 90211
United StatesActive - Recruiting
Beverly Hills Cancer Center & Optima Diagnostic Imaging
Beverly Hills, California 90211
United StatesActive - Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United StatesActive - Recruiting
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania 15232
United StatesSite Not Available
Texas Oncology - Tyler
Tyler, Texas 75702
United StatesActive - Recruiting
Virginia Oncology Associates
Norfolk, Virginia 23502
United StatesActive - Recruiting

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