QUEST Research Institute | Farmington Hills, MI
Status and phase
Conditions
Treatments
About
First-in-human, Phase 1b/2 safety study of the antibody-drug conjugate (ADC) XMT-1536 (upifitamab rilsodotin) administered as an intravenous infusion once every four weeks. Patients with tumor types likely to express NaPi2b were enrolled in dose escalation. Patients with platinum-resistant ovarian cancer and non-small cell lung cancer (adenocarcinoma subtype) were enrolled in the expansion segment of this study. Patients with platinum-resistant, high-grade serous ovarian cancer were enrolled in the UPLIFT segment of this study. In addition to safety assessments, the pharmacokinetics of the drug were assessed along with ADC activity. A QTc sub-study was added for the UPLIFT cohort for a sub-set of sites.
Full description
This is a multi-center study of XMT-1536 (upifitamab rilsodotin) in patients with tumors likely to express NaPi2b, focusing on patients with platinum-resistant ovarian cancer and non-small cell lung cancer, adenocarcinoma subtype. XMT-1536 (upifitamab rilsodotin) was administered as an intravenous infusion once every four weeks. The study consisted of three segments: dose escalation (DES), dose expansion (EXP), and the pivotal cohort (UPLIFT). The DES segment studied small groups of patients who received increased doses. A Safety Review Committee was established to review the data from each dose level before moving to the next higher dose. The dose escalation cohort has ended and is no longer enrolling patients. Enrollment into the EXP segment consisted of 2 parallel cohorts of patients to confirm the dose that has been identified in DES and estimate the objective response rate in each patient population. The EXP and UPLIFT cohorts are no longer enrolling patients. All adverse events were graded according to the National Cancer Institute (NCI) Common Terminology Criteria version (CTCAE v5.0). Throughout the study, pharmacokinetics were measured using proprietary assays developed by Mersana. Anti-cancer activity were measured via RECIST.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
General Inclusion Criteria (for Dose Escalation, Expansion, and UPLIFT):
ECOG performance status 0 or 1
Measurable disease as per RECIST, version 1.1
Resolution of all acute toxic effects of prior therapy or surgical procedures to ≤Grade 1 (except alopecia, stable immune-related toxicity such as hypothyroidism on hormone replacement, adrenal insufficiency on ≤10 mg daily prednisone [or equivalent], chronic Grade 2 peripheral sensory neuropathy after prior taxane therapy).
Cardiac left ventricular ejection fraction (LVEF) ≥50% or ≥ the institution's lower limit of normal by either Echo or MUGA scan
Adequate organ function as defined by the following criteria:
Aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) ≤1.5 times the institutional ULN.
Albumin ≥3.0 g/dL
Able to provide informed consent.
General Exclusion Criteria (for Dose Escalation, Expansion, and UPLIFT) :
Ovarian Cancer Inclusion Criteria for UPLIFT:
Histological diagnosis of high grade serous ovarian cancer, which includes fallopian tube, or primary peritoneal cancer, that is metastatic or recurrent.
Platinum-resistant disease
One to 4 prior lines of systemic therapy for ovarian cancer
a. Prior treatment with bevacizumab is required for patients with 1 to 2 prior lines of therapy
Patients must be willing to provide an archival tumor tissue block or slides or if not available, undergo procedure to obtain a new tumor biopsy using a low-risk, medically routine procedure
Ovarian Cancer Exclusion Criteria for UPLIFT:
Ovarian Cancer Inclusion Criteria for QTc sub-study:
Note: patients must meet all UPLIFT cohort inclusion criteria in order to participate in the QTc sub-study
• Study patient has agreed to remain in the clinic for the additional QTc related study activities on the Day 1 of Cycle 1 and Cycle 3.
Ovarian Cancer Exclusion Criteria for QTc sub-study:
Primary purpose
Allocation
Interventional model
Masking
523 participants in 5 patient groups
Loading...
Central trial contact
Jamie Barrett
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal