IRB Study Number 24-126
Status Recruiting
Institute Taussig Cancer Institute
Description
Primary Objective
To evaluate the safety and tolerability of KB707 in adults with local or advanced metastatic solid tumor malignancies.
Secondary Objectives
To evaluate whether the proposed dose ranges include the maximum tolerated dose of KB707.
To evaluate preliminary efficacy of KB707.
Inclusion Criteria
The subject or legally authorized representative must have read, understood, and signed an Institutional Review Board/Ethics Committee (IRB/IEC) approved Informed Consent Form and must be able to and willing to follow study procedures and instructions.
Life expectancy >12 weeks
Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at Screening
Have measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) at Screening
Have at least one injectable tumor that is accessible by transcutaneous administration.
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 ≤3× 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 ≤2× ULN
Cohort 4 only:
Histologically confirmed diagnosis of a locally advanced or metastatic solid tumor 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.
Age 18 years or older at the time of informed consent
Note: Under Amendment 3, enrollment is closed.
In addition to the Inclusion Criteria described in Section 5.3, an individual must meet the following criteria to enroll in Cohort 5:
- Histologically confirmed stage III (unresectable) or stage IV melanoma, as per American Joint Committee on Cancer (AJCC) staging system (8th edition; AJCC 2017) and
i. Subject has not received prior anti-cancer therapy for advanced or metastatic melanoma (including therapy for neoadjuvant, adjuvant, locally advanced or metastatic disease, including all systemic therapy including tyrosine kinase inhibitors [BRAF, MEK, mTOR], bevacizumab, immuno-oncology therapy, and/or cytotoxic chemotherapy), or
ii. Subject has unresectable or metastatic melanoma and has previously failed PD-1 treatment (including PD-1 monotherapy, PD-1 and LAG-3, and PD-1 in combination with CTLA‑4).
- Age 12 years or older at the time of informed consent
Exclusion Criteria
Prior surgery or radiation therapy must be fully recovered, including all radiation -related toxicities and subject does not require systemic corticosteroids
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
Have known history of positive human immunodeficiency virus (HIV1/2)
Any 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
In addition to the Exclusion Criteria described in Section 5.4, an individual meeting any of the following criteria is ineligible for Cohort 5:
The subject must not have active brain metastases or leptomeningeal metastases
Subject has a known additional malignancy that is progressing or requires active treatment.
Prior anti-LAG-3/anti-PD-1 therapy was intolerable and required discontinuation of treatment
Subject has uveal/ocular melanoma.
