A Phase 1 interventional study of XMT-1522 in Advanced Breast Cancer, Advanced Nonsmall Cell Lung Cancer and Advanced Gastric Cancer, sponsored by Mersana Therapeutics. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-24.
Sponsored by Mersana Therapeutics · Phase 1, Interventional, and Treatment
This Phase 1b trial is an open label, multi-center study of XMT-1522 administered as an intravenous infusion once every three weeks. The dose escalation part of the study will establish the maximum tolerated dose or recommended Phase 2 dose for in patients with advanced breast cancer and either a HER2 immunohistochemistry (IHC) score of at least 1+ using a validated IHC assay or with evidence of HER2 amplification. Patients with HER2 positive (by IHC or amplification) gastric cancer or nonsmall cell lung cancer may also be eligible for participation in dose escalation. Upon completion of dose escalation, the cohort expansion segment of the study will consist of four parallel cohorts of different patients groups to confirm the maximum tolerated dose or the recommended Phase 2 dose and estimate the objective response in each of the patient populations.
The dose escalation segment of the study utilizes a 3+3 design. Initially, 3 patients will be dosed at each dose level. The first 3-week cycle of treatment constitutes the dose limiting toxicity (DLT) evaluation period. If none of the 3 patients experience a DLT during the evaluation period and the Safety Review Committee agrees this was a reasonably well tolerated dose, 3 patients will be enrolled at the next dose level. However, in the event of 1 DLT, 3 additional patients will be enrolled at the same dose level. Any dose level with 2 or more DLTs will be considered to have exceeded the maximum tolerated dose and subsequent patients will be enrolled at lower dose levels. After the first cycle, patients may continue to receive XMT-1522 until disease progression as long as the drug is well-tolerated and patients continue to derive clinical benefit in the opinion of the Investigator.
After completion of the dose escalation, the expansion segment will enroll the patients with the following kinds of cancer:
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 120 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Mersana Therapeutics is the lead sponsor of 9 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients who participate in the dose escalation segment of the study cannot participate in the expansion segment of the study.
XMT-1522 treatment will administered in groups of patients who will receive doses that increase over time. Once the maximum tolerated dose or recommended Phase 2 dose is achieved, new groups of patients will receive XMT-1522 at this fixed dose.
Drug: XMT-1522
one intravenous dose administered in-clinic every 21 days
Maximum tolerated dose or recommended Phase 2 dose
Evaluate adverse events and use of concomitant medication use after XMT-1522 doses
Time frame: Up to 14 weeks, from the date of first dose until unacceptable side effects or a dose-limiting toxicity is met.
Time of maximum observed concentration of XMT-1522
Determine the pharmacokinetics of XMT-1522
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-1522
Determine the pharmacokinetics of XMT-1522
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-1522
Determine the pharmacokinetics of XMT-1522
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-1522
Monitor tumor size
Time frame: Every 6 weeks up to 12 months
Anti-drug antibody
Analyze blood for antibodies to XMT-1522 and neutralizing antibodies
Time frame: Before first dose, 21 and 42 days after first dose, and every 42 days until end of study which is estimated to be 100 days (14 weeks) after first dose
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Mersana Therapeutics