Ph II Study of Enfortumab Vedotin in Patients With Advanced or Metastatic CRC or HCC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorH. Lee Moffitt Cancer Center and Research Institute
About this trial
This study is a multi-indication, open-label, single-treatment arm, parallel-cohort phase II study of enfortumab vedotin in adult participants with advanced or metastatic colorectal cancer (CRC) or hepatocellular carcinoma (HCC) who have been previously treated with one or more lines of systemic therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must have measurable disease according to RECIST v1.1. Lesions in a prior radiation field must have progressed subsequent to radiotherapy to be considered measurable.
Participants must have had progression or recurrence of CRC or HCC during or following receipt of most recent therapy.
Legally an adult according to local regulation at the time of signing informed consent, and minimum age of 18 years
ECOG performance status ≤1
Disqualifiers
Radiotherapy or major surgery or chemotherapy, biologics, investigational agents, and/or immunotherapy that is not completed 2 weeks prior to first dose of study drug.
Ongoing sensory or motor neuropathy Grade ≥2. Ongoing clinically significant toxicity (Grade 2 or higher) associated with prior treatment (including systemic therapy, radiotherapy or surgery).
Active central nervous system (CNS) metastases. Participants with treated CNS metastases are permitted on study if all the following are true: i. CNS metastases have been clinically stable for at least 6 weeks prior to screening and baseline scans show no evidence of new or enlarged metastasis ii. If requiring steroid treatment for CNS metastases, the patient is on a stable dose ≤20 mg/day of prednisone or equivalent for at least 2 weeks iii. Participant does not have leptomeningeal disease
Prior enrollment in an enfortumab vedotin study or prior treatment with other MMAE-based ADCs.
Trial design
Design model
Parallel
Treatments tested in this trial
Enfortumab Vedotin
DrugEnfortumab vedotin is a type of prescription medicine known as an antibody-drug conjugate.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Cohort 1: Colorectal CancerExperimental treatment 1 intervention
Group B: Cohort 2: Hepatocellular CarcinomaExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Overall response rate (ORR)
The ORR is defined as the proportion of evaluable patients with confirmed CR or PR according to RECIST v1.1.
Time frame
Up to 3 yearsSecondary outcomes
1
Duration of Response (DOR)
The DOR is defined as the time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of PD (per RECIST v1.1) or to death due to any cause, whichever comes first.
Time frame
Up to 3 years2
Progression-free Survival (PFS)
PFS is defined as the time from start of study treatment to first documentation of objective tumor progression (PD per RECIST v1.1), or to death due to any cause, whichever comes first.
Time frame
Up to 3 years3
Overall Survival (OS)
OS is defined as the time from start of study treatment to date of death due to any cause.
Time frame
Up to 3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
H. Lee Moffitt Cancer Center and Research Institute
Lead sponsor
Astellas Pharma Inc
Collaborator
Source ClinicalTrials.gov