Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 an investigational antibody-drug conjugate being developed for platinum-resistant ovarian cancer. It is also being studied in non-small cell lung cancer and non-small cell adenocarcinoma. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
Upifitamab rilsodotin targets NaPi2b, a protein expressed on the surface of certain cancer cells. It is designed to deliver a cytotoxic payload to NaPi2b-expressing tumors. The drug is being evaluated in cancers likely to express NaPi2b, including platinum-resistant ovarian cancer and non-small cell lung cancer.
Upifitamab rilsodotin is being developed by Day One Biopharmaceuticals, Inc., a company traded on the NASDAQ under the ticker symbol DAWN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with NaPi2b-expressing cancers.
Upifitamab rilsodotin is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. The drug is being studied in early-stage trials to assess its safety, tolerability, and preliminary efficacy in patients with platinum-resistant ovarian cancer and other NaPi2b-expressing tumors.
Upifitamab rilsodotin is being evaluated in three Phase 1 clinical trials. NCT03319628 is an active first-in-human study with 523 participants. NCT06517433 is a completed dose escalation study with 62 participants. NCT06517485 is a completed dose expansion study with 142 participants. All trials are enrolling patients in the United States.
Yes, upifitamab rilsodotin is also known as XMT-1536. Clinical trials for the drug use the name XMT-1536 in their titles, such as the first-in-human study of XMT-1536 in cancers likely to express NaPi2b. Both names refer to the same investigational antibody-drug conjugate.