IRB Study Number 24-389
Status Recruiting
Institute Taussig Cancer Institute
Description
Primary Objective
To evaluate the safety and tolerability of inhaled KB707
Secondary Objectives
To evaluate whether the proposed dose ranges include the maximum tolerated dose of KB707
To evaluate the preliminary efficacy of inhaled KB707
Inclusion Criteria
The subject or legally authorized representative must have read, understood, and signed an Institutional Review Board (IRB) approved Informed Consent Form and must be willing and able to comply with study procedures and instructions.
Histologically confirmed diagnosis of advanced solid tumor malignancy affecting the lungs and the individual has progressed on standard of care therapy, cannot tolerate standard of care therapy, refused standard of care therapy, or there is no standard of care therapy. Note: Exceptions may be considered on a case-by-case basis
Age 18 years or older at the time of informed consent.
Life expectancy >12 weeks.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at Screening.
Have at least one measurable lung lesion per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) at Screening.
Demonstrated adequate organ function at Screening, as defined below:
a. WBC count ≥2000/μL (after at least 7 days without growth factor support)
b. Absolute neutrophil count ≥1500/μL (after at least 7 days without growth factor support)
c. Platelet count ≥100×103 μL
d. Hemoglobin ≥9.0 g/dL
e. Serum creatinine ≤2 mg/dL (or glomerular filtration rate ≥40 mL/min)
f. AST and ALT ≤3x upper limit of normal (ULN)
g. Total bilirubin within normal limits unless associated with hepatobiliary metastases or Gilbert’s syndrome, in that case total bilirubin ≤2x ULN
Exclusion Criteria
Prior oncology therapy (chemotherapy, immunotherapy, biological therapy) or participation in another interventional clinical study or treatment with an investigational agent or an investigational device within 21 days or 5 half-lives, whichever is longer, of first dose (Visit 2, Day 1).
Prior surgery or radiotherapy must be fully recovered, including all radiation-related toxicities.
Have known medical history of positive test for, or diagnosis of, human immunodeficiency virus (HIV-1/2).
The subject is pregnant, nursing, or plans to become pregnant during study treatment and through three months after the last dose of KB707.
Subject who is unwilling to comply with contraception requirements per-protocol.
Any clinical condition or clinically significant abnormality that, in the opinion of the Investigator, would impact a subject’s ability to complete all study-related procedures and/or poses an additional risk to the assessment of safety of KB707.
Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol in the opinion of the Investigator.
