A Study of Emi-Le in Participants with Solid Tumors
Recurrent or advanced solid tumor and has disease
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Participants in DES must have at least one measurable disease (target) lesion as defined by RECIST version 1.1.
Tumor tissue, either archival or from a fresh tumor biopsy, available for testing or be willing to undergo a minimally invasive tumor biopsy to obtain tumor tissue for local testing, if not medically contraindicated, prior to Cycle 1 Day 1
Prior treatment with an Antibody Drug Conjugate (ADC) containing an auristatin payload. Prior treatment with another ADC containing other payloads is allowed.
Major surgery within 28 days of starting study treatment, systemic anticancer therapy within the time period of 28 days or 5 half-lives of the prior therapy before starting study treatment (14 days or 5 half-lives for small molecule targeted therapy), whichever is less, or palliative radiation therapy to the chest within 3 months of starting study treatment or to other anatomic sites within 14 days of starting study treatment.
Diagnosis of additional malignancy that required active treatment (including surgery, systemic therapy, and radiation) within 2 years prior to screening, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix.
Untreated CNS metastases (including new and progressive brain metastases), history of leptomeningeal metastasis or carcinomatous meningitis.
Single group
Emi-Le
DrugEmi-Le will be administered through a vein in your arm or port catheter (intravenously)
Frequency of adverse events that are considered dose-limiting toxicities (DLTs) and associated with Emi-Le during the first cycle of treatment (Dose Escalation)
Determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of Emi-Le
Incidence of adverse events (Dose Escalation and Dose Expansion)
Assess the safety and tolerability of Emi-Le by determining the number of patients with adverse events from date of first dose to 60 days post last dose
Objective Response Rate (ORR) (Dose Expansion and EMBLEM-1)
The percentage of patients with a best overall response of complete or partial response as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Objective Response Rate (ORR) (Dose Escalation)
The percentage of patients with a best overall response of complete or partial response as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Duration of response (DOR) (Dose Escalation, Dose Expansion, and EMBLEM-1)
The time from when response criteria are first met until disease progression or death in participants who achieve a complete or partial response
Maximum observed plasma concentration of Emi-Le and payload (Cmax) (Dose Escalation and Dose Expansion)
Cmax is the maximum concentration determined from the measured concentrations in plasma
Area under the concentration-time curve of Emi-Le and payload (AUC) (Dose Escalation and Dose Expansion)
Area under the concentration-time curve for the last measurable concentration (AUC0-last) will be assessed as data permit
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