Ignite Creation Date:
2024-05-06 @ 11:04 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03424603
Status:
COMPLETED
Last Update Posted:
2024-06-11
First Post:
2018-01-24
Brief Title:
Study of STRO-001 an Anti-CD74 Antibody Drug Conjugate in Patients With Advanced B-Cell Malignancies
Sponsor:
Sutro Biopharma Inc
Organization:
Sutro Biopharma Inc
Study Overview
Official Title:
A Phase 1 Open-Label Safety Pharmacokinetic and Preliminary Efficacy Study of STRO-001 an Anti-CD74 Antibody Drug Conjugate in Patients With Advanced B-Cell Malignancies
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
First-in-human Phase 1 trial to study the safety pharmacokinetics and preliminary efficacy of STRO-001 given intravenously every 3 weeks
Detailed Description:
This study is a first-in-human Phase 1 open-label multicenter dose escalation study with dose expansion to identify the maximum tolerated dose MTD the recommended phase 2 doses RP2D and to evaluate the safety tolerability and preliminary anti-tumor activity of STRO-001 in adult subjects with B-cell malignancies MM and NHL who are refractory to or intolerant of all established therapy known to provide clinical benefit for their condition ie trial subjects must not be candidates for any regimens known to provide clinical benefit The study will consist of two parts Part 1 dose escalation and Part 2 dose expansion
The study uses an accelerated dose titration design for dose escalation Doses will be escalated using an N-of-1 per dosing cohort until the first instance of a treatment-related clinically relevant Grade 2 non-hematologic toxicity or a Grade 3 hematologic toxicity of any type is observed during Cycle 1 first 21 days Following this a standard 33 trial design is used for all further escalation cohorts Dose escalation is conducted independently for the two dose escalation tumor cohorts MM and NHL A recommended STRO-001 dose for expansion will be determined for MM and NHL
The dose expansion Part 2 portion of the study will begin when Part 1 is completed Enrollment in dose expansion will include separate tumor cohorts of MM and NHL
In both Part 1 and Part 2 of the study STRO-001 will be dosed as an intravenous IV infusion on Day 1 of a 21-day cycle until disease progression Labs will be drawn on a weekly basis for Cycles 1-4 and every three weeks starting with Cycle 5 Weekly clinical evaluations will be conducted during the first 4 cycles thereafter clinical evaluations will be conducted on infusion days Day 1 of each cycle Samples for pharmacokinetics PK analysis will occur at specific times on Days 1 2 and 8 of the first two cycles of treatment Day 1 of the third cycle of treatment and at End of Treatment visit Additional clinical evaluations and labs may occur at the discretion of the investigator
Subjects who receive any dose of STRO-001 will be included in safety analyses Disease evaluations will include peripheral blood analysis bone marrow assessments and scans as appropriate Disease status will be evaluated per MM-specific or NHL-specific criteria Samples will be collected to assess the PK and immunogenicity of STRO-001 Biomarkers may be assessed from bone marrow peripheral blood andor tissue samples Subjects will continue to receive study drug until disease progression unacceptable toxicity withdrawal of consent or end of study study completion
The study uses an accelerated dose titration design for dose escalation Doses will be escalated using an N-of-1 per dosing cohort until the first instance of a treatment-related clinically relevant Grade 2 non-hematologic toxicity or a Grade 3 hematologic toxicity of any type is observed during Cycle 1 first 21 days Following this a standard 33 trial design is used for all further escalation cohorts Dose escalation is conducted independently for the two dose escalation tumor cohorts MM and NHL A recommended STRO-001 dose for expansion will be determined for MM and NHL
The dose expansion Part 2 portion of the study will begin when Part 1 is completed Enrollment in dose expansion will include separate tumor cohorts of MM and NHL
In both Part 1 and Part 2 of the study STRO-001 will be dosed as an intravenous IV infusion on Day 1 of a 21-day cycle until disease progression Labs will be drawn on a weekly basis for Cycles 1-4 and every three weeks starting with Cycle 5 Weekly clinical evaluations will be conducted during the first 4 cycles thereafter clinical evaluations will be conducted on infusion days Day 1 of each cycle Samples for pharmacokinetics PK analysis will occur at specific times on Days 1 2 and 8 of the first two cycles of treatment Day 1 of the third cycle of treatment and at End of Treatment visit Additional clinical evaluations and labs may occur at the discretion of the investigator
Subjects who receive any dose of STRO-001 will be included in safety analyses Disease evaluations will include peripheral blood analysis bone marrow assessments and scans as appropriate Disease status will be evaluated per MM-specific or NHL-specific criteria Samples will be collected to assess the PK and immunogenicity of STRO-001 Biomarkers may be assessed from bone marrow peripheral blood andor tissue samples Subjects will continue to receive study drug until disease progression unacceptable toxicity withdrawal of consent or end of study study completion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None