Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SRF231 · 1 trial · 2 indications
The number of patients in Part A who experienced a DLT during Cycle 1 or completed at least 75% of the prescribed Cycle 1 SRF231 dose will be used to assess tolerability and determine the appropriate dose for Part B.
For Part A, the NTD is the dose level at which 2 or more patients experience a DLT in the first cycle of treatment.
For Part A, the MTD is defined as the dose level immediately below the non-tolerated dose (NTD). A total of 6 patients must be treated at a dose level for it to be considered the MTD.
Safety and tolerability of SRF231 monotherapy will be assessed by summarizing adverse events (AEs) and will be based on treatment-emergent AEs (TEAEs). A TEAE is an AE that emerges or worsens in the period from the first dose of study treatment to 30 days after the last dose of study drug assessed by per CTCAE version 4.03 or higher.
| Arm | Type | Description |
|---|---|---|
| Part A | EXPERIMENTAL | Part A will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of SRF231 as a monotherapy in patients with advanced solid tumors and lymphoma/Chronic lymphocytic leukemia. |
| Part B Cohort 1 | EXPERIMENTAL | Depending upon the results from Part A of the study and the decision from the Safety Review Committee, 1 or 2 doses or dosing frequencies of SRF231 in select advanced solid and hematologic malignancies. |
| Name | Type | Description |
|---|---|---|
| SRF231 | DRUG | SRF231 specifically blocks the interaction between CD47 and signal regulatory protein alpha and acts as a potent enhancer of human tumor cell phagocytosis. |
Inclusion Criteria: 1. ≥18 years of age. 2. Failure to respond to standard therapy, and for whom no appropriate therapies are available (based on the judgment of the Investigator). 3. Histological or cytological evidence of advanced, relapsed, or refractory, solid and hematologic cancers that are n...