Status and phase
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About
This is a Phase 1/2a, open-label, multicenter, dose-escalation/dose-expansion study of YBL-006, in participants with Advanced Solid Tumors. This multicenter study will be conducted in approximately 11-14 participants in the dose escalation phase, and approximately 39-76 participants in dose expansion phase.
Full description
Study will consist of three periods:
Dose Escalation:
An accelerated titration design will be utilized for the lowest dose cohort (0.5 mg/kg) in the dose escalation part. Whereas the traditional 3 + 3 design will be utilized for the higher dose cohorts until the proposed starting dose for the Expansion Cohort is determined
Expansion Cohorts:
Up to four tumor-specific expansion cohorts consisting of approximately 39 to 76 participants will evaluate the safety, efficacy, PK, and PD of YBL-006 at the proposed doses of YBL-006"
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Written consent on an IRB/ IEC-approved ICF prior to any study-specific evaluation.
Male or female aged ≥18 years (or age of legal adult, whichever is older).
Life expectancy of at least 3 months.
ECOG performance status of 0 to 1.
Availability of archival tumour tissue and consent to provide archival tumour for retrospective biomarker analysis, or consent to undergo a fresh tumour biopsy during screening. Participants who do not have an existing (archived) tumour specimen and are unwilling to undergo a biopsy may be enrolled with prior approval from the Sponsor.
For participants in dose escalation only: Histologically confirmed solid tumours (except primary CNS tumours) that are unresectable, locally advanced, or metastatic and have progressed following all standard treatments or is not appropriate for standard treatments.
Must have at least one measurable lesion based on RECIST Version 1.1. A previously irradiated lesion can be considered a target lesion if the lesion is well defined, measurable and there is objective evidence of interval increase in size.
CNS metastasis must be without evidence of progressive neurological symptoms or requires increasing doses of corticosteroids to control the CNS disease for at least 4 weeks. If a participant requires corticosteroids for management of CNS disease, the dose must have been stable with low-dose (same or less than 10 mg/day prednisone or equivalent) for at least two weeks preceding C1D1.
Immunosuppressive doses of systemic medications, such as steroids (doses > 10 mg/day prednisone or equivalent) must be discontinued at least 2 weeks before IP administration.
Prior surgery that required general anaesthesia must be completed at least 14 days before IP administration. Surgery requiring local/epidural anaesthesia must be completed at least 72 hours before IP administration and participants should be recovered.
Adequate haematological and biological function, confirmed by the following laboratory values:
Neutrophils ≥ 1000/μL Platelets ≥ 75,000/μL Haemoglobin ≥ 9.0 g/dL (may have been transfused) Creatinine ≤ 1.5×upper limit of normal (ULN) Aspartate aminotransferase (AST) ≤ 2.5×ULN (Except with liver metastasis, AST ≤ 5×ULN) Alanine aminotransferase (ALT) ≤ 2.5×ULN (Except with liver metastasis, AST ≤ 5×ULN) Bilirubin ≤ 1.5×ULN (except participants with Gilbert's syndrome, who must have total bilirubin < 3.0 mg/dL).
Women must meet 1 of the following criteria: postmenopausal for at least 24 consecutive months; surgically incapable of bearing children (i.e., have had a hysterectomy or bilateral oophorectomy); or utilizing a reliable form of contraception. In general, the decision for appropriate methods to prevent pregnancy should be determined via discussions between the Investigator and the study participant. WOCBP must agree to use a reliable form of contraceptive during the study Treatment Period and for at least 120 days following the last dose of IP.
Men must agree to the use of acceptable contraceptive use and avoid sperm donation, during the study Treatment Period and for at least 180 days after the last dose of IP.
For the Expansion Cohort, participants enrolling must also meet the following inclusion criteria:
Confirmed diagnosis of one of the following tumour types:
For all Expansion Cohorts (B1, B2, B2 reserve, and B3), histologically confirmed advanced solid tumours (except primary CNS tumours) that are unresectable, locally advanced, or metastatic and have progressed following all standard treatments, or are not appropriate for standard treatments.
For the B3 cohort, participants must meet one of the following:
The following tumour types are eligible for the B3 cohort:
For Korea only, participants may be enrolled, provided all of the following requirements are met:
No additional MSI-H test is required if this test has been completed previously. However, if the participant did not proceed with this test, then additional testing should be completed at a local facility.
d. Histologically confirmed diagnosis of non-clear cell renal cell carcinoma (RCC), anal squamous cell carcinoma (aSCC), uterine cervical cancer, cutaneous squamous cell carcinoma of the skin (cSCC), uterine endometrial carcinoma, tumours which are tumour mutational burden-high (TMB-H), epithelial tumour of the penis (squamous cell carcinoma or adenocarcinoma), neuroendocrine tumour (any origin, pancreatic or non-pancreatic), and nasopharyngeal cancers.
TMB-H: ≥ 10 mutations/megabase, determined at the local (site) laboratory is acceptable for study enrolment.
e. Histologically or cytologically confirmed recurrent or metastatic HNSCC.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
90 participants in 8 patient groups
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Data sourced from clinicaltrials.gov
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