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Association details:
Evidence:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Phase 3 Study of Upifitamab Rilsodotin Maintenance in Platinum-Sensitive Recurrent Ovarian Cancer (UP-NEXT)

Excerpt:
...Participant must provide either a tumor tissue block or fresh cut slides for measurement of NaPi2b expression by a central laboratory. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

First-in-Human Study of XMT-1536 in Cancers Likely to Express NaPi2b

Excerpt:
...DES and EXP: Time of maximum observed concentration of XMT-1536 (upifitamab rilsodotin)`DES and EXP: Maximum concentration of XMT-1536 (upifitamab rilsodotin)`DES and EXP: Area under the concentration curve of the last measurable concentration of XMT-1536 (upifitamab rilsodotin)`DES: Anti-neoplastic effects of XMT-1536 (upifitamab rilsodotin)`DES and EXP: Anti-drug antibody and neutralizing antibody`UPLIFT: Confirmed Investigator-assessed objective response rate of XMT-1536 (upifitamab rilsodotin) regardless of NaPi2b expression`UPLIFT: Confirmed objective response rate by independent radiology review (IRR) for patients with high NaPi2b and overall`UPLIFT: Duration of objective response (DOR)`UPLIFT: Incidence and severity of adverse events`QTc Sub-Study: Evaluation of the effect of XMT-1536 on QTcF in patients with platinum-resistant HGSOC by timepoint analysis`QTc Sub-Study: Evaluation of the effect of XMT-1536 on the PR-interval (PR), QRS duration (QRS), Heart Rate (HR), and ECG morphology...
Trial ID:
More C2 evidence
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Upifitamab Rilsodotin Maintenance in Platinum-Sensitive Recurrent Ovarian Cancer (UP-NEXT)

Excerpt:
...Participant must provide either a tumor tissue block or fresh cut slides for measurement of NaPi2b expression by a central laboratory....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

A dose escalation and expansion study of XMT-1536 en patients with solid tumors.

Excerpt:
...For dose escalation:Objective response rate (ORR)Duration of response (DOR)Disease control rate (DCR) = CR + PR + SD (any duration)PK profile of XMT-1536, its release product, and metabolitesAnti-drug antibody levels and nAb levels NaPi2b protein or RNA levels measured in tumor samplesFor dose expansion:PK profile of XMT-1536, its release product, and metabolitesAnti-drug antibody levels and nAb levels NaPi2b protein or RNA levels measured in tumor samplesAnalyze the effect of NaPi2b expression on objective responseDOR, PFS, OSSub-group analyses of responses in ovarian cancer patients including patientspreviously treated and failed therapy with bevacizumab and patients with and without BRCA mutation who were previously treated and failed therapy with PARP inhibitors.Uplift:Confirmed investigator-assessed ORR in the entire ITT populationORR by IRR in the ITT-Higher NaPi2b population; ORR by IRR in the entire ITT populationDOR in the ITT-Higher NaPi2b populationDOR in the entire ITT populationSafety and tolerability measures...
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Mersana Therapeutics Reports Positive Interim Data from the Expansion Portion of the XMT-1536 Phase 1 Study

Published date:
05/27/2020
Excerpt:
Data continue to support a NaPi2b biomarker-based patient selection strategy….Among those patients with higher NaPi2b expression, two (2/14) patients achieved a CR, and two (2/14) achieved a PR.