Neoplasms

Blood and Lymph Conditions

All Conditions

Hematologic Neoplasms

Hematologic Diseases

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.

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.

SRF231 specifically blocks the interaction between CD47 and signal regulatory protein alpha and acts as a potent enhancer of human tumor cell phagocytosis.

SRF231

Robert Ross, MD

This Phase 1/1b, open-label, first-in-human, monotherapy study will be conducted in 2 parts. Part A will consist of the SRF231 monotherapy dose-escalation portion of the study, and will enroll up to 48 patients with advanced solid tumors and hematological cancers. Part B will include monotherapy expansion cohorts in advanced solid and hematologic cancers to further examine SRF231 as monotherapy (100 patients total).

This first-in-human study is designed to evaluate the safety and tolerability of SRF231 as a monotherapy via dose escalation (Part A), and to determine the dose(s) of SRF231 to be further examined in expansion cohorts as monotherapy. The preliminary clinical activity of SRF231 administered as monotherapy will be characterized, along with pharmacokinetics (PK) and pharmacodynamics. In Part B, the safety and tolerability of SRF231 as monotherapy will be evaluated in select patient cohorts of advanced cancers and evaluate clinical activity. The study also is designed to examine the effect of SRF231 monotherapy on peripheral blood immune cell subsets, peripheral blood gene expression, and serum biomarkers

This Phase 1/1b, open-label, first-in-human, monotherapy study will be conducted in 2 parts. Part A will consist of the SRF231 monotherapy dose-escalation portion of the study, and will enroll up to 48 patients with advanced solid tumors and lymphoma/CLL.

Part B will include 5 monotherapy expansion cohorts: in advance solid and hematologic cancers (100 patients total).

Study of SRF231 in Patients With Advanced Solid and Hematologic Cancers

A Phase 1 Study of SRF231 in Patients With Advanced Solid and Hematologic Cancers

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.

Cmax in serum for all patients who receive at least one dose of SRF231 and had at least one measurable concentration based on the actual sample collection times determined using standard noncompartmental methods.

Tmax in serum for all patients who receive at least one dose of SRF231 and had at least one measurable concentration based on the actual sample collection times determined using standard noncompartmental methods.

AUC 0-last for all patients who receive at least one dose of SRF231 and had at least one measurable concentration based on the actual sample collection times determined using standard noncompartmental methods

AUC 0-INF for all patients who receive at least one dose of SRF231 and had at least one measurable concentration based on the actual sample collection times determined using standard noncompartmental methods.

T1/2 for all patients who receive at least one dose of SRF231 and had at least one measurable concentration based on the actual sample collection times determined using standard noncompartmental methods.

Blood samples will be collected from all patients at multiple time points for analysis of CD47 receptor occupancy by SRF231. PD analyses will be descriptive and summary tabulations may be produced.

Determine the incidence of ADAs in all patients who receive at least one dose of SRF231 and had at least one measurable sample.

ORR will be estimated by the percentage of patients achieving a best overall response of CR or PR using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, International Working Group Lugano Criteria (IWG Lugano) or other tumor-appropriate response criteria.

DoR defined as the time from first documented response to documented disease progression using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, International Working Group Lugano Criteria (IWG Lugano) or other tumor-appropriate response criteria will be summarized.

DCR defined as the percentage of patients with CR, PR or SD determined using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, International Working Group Lugano Criteria (IWG Lugano) or other tumor-appropriate response criteria will be summarized.

PFS defined as the time from the first treatment on study to death or documented disease progression using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, International Working Group Lugano Criteria (IWG Lugano) or other tumor-appropriate response criteria will be summarized.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of SRF231 in Patients With Advanced Solid and Hematologic Cancers	NCT03512340	Advanced Solid ... Hematologic Can...	SRF231	18 Years - 99 Years	Surface Oncology
Study of SRF231 in Patients With Advanced Solid and Hematologic Cancers	NCT03512340	Advanced Solid ... Hematologic Can...	SRF231	18 Years - 99 Years	Surface Oncology
Study of SRF231 in Patients With Advanced Solid and Hematologic Cancers	NCT03512340	Advanced Solid ... Hematologic Can...	SRF231	18 Years - 99 Years	Surface Oncology

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Spots Global Cancer Trial Database for sirp α

Every month we try and update this database with for sirp α cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sirp α cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.