Phase 1b, a study in high grade serous ovarian cancer and nonsmall cell lung cancer to evaluate the safety and clinical activity of the antibody-drug conjugate (ADC) XMT-1592.
This Phase 1b trial is an open-label, multi-center study of XMT-1592 administered as an intravenous infusion once every 3 weeks. The dose-escalation (DES) segment of the study will establish the expansion (EXP) dose and is intended to establish the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) for XMT-1592 in patients with high grade serous ovarian cancer (HGSOC) or non-small cell lung cancer (NSCLC), adenocarcinoma subtype. The EXP segment of the study will consist of 2 parallel cohorts of patients (HGSOC and NSCLC) to confirm the MTD or RP2D and estimate the objective response rate in each selected patient population. In DES, the observation period for dose-limiting toxicities is 21 days, between Day 1 through the end of Cycle 1 which includes the pre-dose assessments before receiving the Cycle 2 dose. All adverse events (AEs) will be graded according to NCI, CTCAE v5.0). In general, AEs ≥Grade 3 are dose-limiting toxicities with some modifications.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
XMT-1592 will be administered once every 21 or 28 days until disease progression, unacceptable toxicity, or either the patient or study physician determines it is in the best interest of the patient to discontinue participation in the study.
Mary Crowley Cancer Research Center
Dallas, Texas, United States
Maximum tolerated dose or recommended Phase 2 dose
Evaluate adverse events and use of concomitant medication use after XMT-1592 doses
Time frame: Up to 36 weeks, from the date of first dose until unacceptable side effects or a dose-limiting toxicity is me
Time of maximum observed concentration of XMT-1592
Determine the pharmacokinetics of XMT-1592
Time frame: Daily for one week after first dose; weekly until 21 days after first dose; immediately before and after and 1 week after all subsequent doses
Maximum concentration of XMT-1592
Determine the pharmacokinetics of XMT-1592
Time frame: Daily for one week after first dose; weekly until 21 days after first dose; immediately before and after and 1 week after all subsequent doses
Area under the concentration curve of the last measurable concentration of XMT-1592
Determine the pharmacokinetics of XMT-1592
Time frame: Daily for one week after first dose; weekly until 21 days after first dose; immediately before and after and 1 week after all subsequent doses
Antineoplastic effects of XMT-1592
Monitor tumor size
Time frame: Every 6 weeks for up to 36 weeks
Anti-drug antibody and neutralizing antibody
Analyze blood for antibodies to XMT-1536 and neutralizing antibodies
Time frame: Every 3 weeks for 9 weeks then every 6 weeks for upto 36 weeks
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