Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as XMT-1536, UpRi
upifitamab rilsodotin · 3 trials · 3 indications
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...
Upifitamab rilsodotin is being studied for platinum resistant ovarian cancer. It is also being evaluated in non-small cell lung cancer, including metastatic non-small cell adenocarcinoma. It is an investigational therapy and has not been approved for commercial use.
Upifitamab rilsodotin is being developed by Day One Biopharmaceuticals, Inc., which trades under the ticker DAWN. The company is the sponsor behind the clinical program evaluating the agent in platinum resistant ovarian cancer and related tumor types.
Upifitamab rilsodotin is in Phase 1 clinical development. Three Phase 1 trials have been conducted or are ongoing, with one currently active and not recruiting and two completed. It remains an investigational agent and is not FDA approved.
Upifitamab rilsodotin has been studied in three Phase 1 first-in-human trials: NCT06517485, a completed dose expansion study; NCT06517433, a completed dose escalation study; and NCT03319628, an active but not recruiting study. Together these trials enrolled 727 participants across platinum resistant ovarian cancer and non-small cell lung cancer.
Upifitamab rilsodotin is a monoclonal antibody designed to target cancers likely to express NaPi2b. Its trials were conducted in tumor types expected to express this target, including platinum resistant ovarian cancer and non-small cell lung cancer. The antibody format places it in the -mab antibody class.