Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06517485 | First-in-Human Dose Expansion Study of XMT-1536 in Cancers Likely to Express NaPi2b | PHASE1 | COMPLETED | 142 | — | — | Jul 30, 2019 | Aug 3, 2022 | Jul 24, 2024 | 1 | United States |
| NCT03319628 | First-in-Human Study of XMT-1536 in Cancers Likely to Express NaPi2b | PHASE1 | ACTIVE NOT_RECRUITING | 523 | — | — | Dec 12, 2017 | Oct 31, 2024 | Nov 13, 2023 | 1 | United States |
| NCT06517433 | First-in-Human Dose Escalation Study of XMT-1536 in Cancers Likely to Express NaPi2b | PHASE1 | COMPLETED | 62 | — | — | Dec 12, 2017 | Jul 9, 2021 | Jul 24, 2024 | 1 | United States |
Evaluate incidence and severity of adverse events
Evaluate adverse events and concomitant medication use after XMT-1536 (upifitamab rilsodotin) doses
Evaluate incidence and severity of adverse events
Monitor tumor size
Confirmed ORR is defined as the proportion of patients who have achieved a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 after the initiation of study treatment.
"The concentration-QTcf change from baseline deltaQTcF analysis and analysis of central tendency for deltaQTcF
| Arm | Type | Description |
|---|---|---|
| Dose Expansion - Ovarian Cancer | EXPERIMENTAL | Once the maximum tolerated dose or recommended Phase 2 dose is achieved in dose escalation, new groups of patients will receive XMT-1536 (upifitamab rilsodotin) at this fixed-dose. This cohort is closed to enrollment. |
| Dose Expansion - NSCLC adenocarcinoma | EXPERIMENTAL | Once the maximum tolerated dose or recommended Phase 2 dose is achieved in dose escalation, new groups of patients will receive XMT-1536 (upifitamab rilsodotin) at this fixed-dose. This cohort is closed to enrollment. |
| Dose Escalation | EXPERIMENTAL | XMT-1536 (upifitamab rilsodotin) treatment is administered in groups of patients who will receive doses that increase over time. This cohort is closed to enrollment. |
| Pivotal Cohort (UPLIFT) | EXPERIMENTAL | Patients with platinum-resistant ovarian cancer will receive XMT-1536 (upifitamab rilsodotin) to further confirm the efficacy. This cohort is closed to enrollment. |
| QTc Sub-Study | EXPERIMENTAL | For sites participating in the sub-study, patients with platinum -resistant ovarian cancer will have the option to enroll in this sub-study to evaluate potential changes in the QTc interval following administration of XMT-1536. This cohort is closed to enrollment. |
| Name | Type | Description |
|---|---|---|
| upifitamab rilsodotin | DRUG | XMT-1536 will be administered once every 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. For sites participating in the sub-study, patients with platinum -resistant ovarian cancer will have the option to enroll in this sub-study to evaluate potential changes in the QTc interval following administration of XMT-1536 |
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...