October 2024 SCRI Release Copied
SCRI Trials and Trial Regimen Updates
The following updates were completed between Sept. 20, 2024, through Oct. 18, 2024. Sarah Cannon Research Institute now manages all SCRI/USOR trials and trial regimens. For questions about these trials and regimens, please contact SCRI.DLEMRAnalysts@scri.com.
New Builds Completed
| Study Number | Notes for New Build |
| 23300 | USOR 23300 GI 368 Phase I TORL-2-307-ADC Q21D |
| 23182 | USOR 23182 AML 72 Phase 1 Consolidation Ziftomenib + (HiDAC) Cytarabine Q28D
USOR 23182 AML 72 Phase 1 Consolidation Ziftomenib + (IDAC) Cytarabine Q28D USOR 23182 AML 72 Phase 1 Induction Ziftomenib + (FLAG-IDA) Fludarabine D1-4 + Cytarabine D1-5 + G-CSF D-1-5 + Idarubicin D1,3 Q28D USOR 23182 AML 72 Phase 1 Maintenance Ziftomenib Q28D USOR 23182 AML 72 Phase 1 Ziftomenib + (LDAC) Cytarabine Q28D USOR 23182 AML 72 Phase 1 Ziftomenib + Gilteritinib Q28D |
| 24249 | USOR 24249 PRO 37 Extended Access Nab-Sirolimus IV D1,8 (+/- Letrozole PO) Q21D |
| 23307 | USOR 23307 GI 370 Phase 1b Arm B AMG 193 + mFOLFIRINOX Q28D
USOR 23307 GI 370 Phase 1b Part 1 Arm A bAMG 193 + nab-Paclitaxel (D1,8,15) + Gemcitabine (D1,8,15) Q28D USOR 23307 GI 370 Phase 1b Part 1 BTC AMG 193 + Pembrolizumab + Gemcitabine + Cisplatin D 1, 8 Q21D |
| 23276 | USOR 23276 LUN 547 Phase III Tarlatamab or Placebo D1,8,15 fb D1,15 Q28D |
| 23297 | USOR 23297 LUN 549 Phase 1b Subprotocol A Part 1 Arm A AMG 193 + Carboplatin + Paclitaxel + Pembrolizumab Q21D
USOR 23297 LUN 549 Phase 1b Subprotocol A Part 1 Arm B AMG 193 + Carboplatin + Pemetrexed + Pembrolizumab Q21D USOR 23297 LUN 549 Phase 1b Subprotocol A Part 1 Arm C AMG 193 + Pembrolizumab Q21D USOR 23297 LUN 549 Phase 1b Subprotocol B Part 1 AMG 193 + Sotorasib Q21D USOR 23297 LUN 549 Phase 1b Subprotocol C Part 1 AMG 193 Q21D |
| 24073 | USOR 24073 | MM185| Phase 3 | Arm A Teclistamab SQ Cycle 1 Step Up Dosing
USOR 24073 | MM185| Phase 3 | Arm A Teclistamab SQ Q28D Cycle 2+ USOR 24073 | MM185| Phase 3 | Arm B Carfilzomib D1,8,15 + Dexamethasone D1,8,15,22 fb D1,8,15 Q28D USOR 24073 | MM185| Phase 3 | Arm B Carfilzomib D1,2,8,9,15,16 + Dexamethasone D1,2,8,9,15,16,22,23 Q28D USOR 24073 | MM185| Phase 3 | Arm B Pomalidomide D1-14 + Bortezomib D1,4,8,11 fb D1,8 + Dexamethasone Q21D
|
| 24065 | USOR 24065 CNS 37 Phase 2 BPM31510 IV + Vitamin K1 SC + Temozolomide PO qd + XRT Q7D
USOR 24065 CNS 37 Phase 2 Additional Temozolomide Q28D |
Updated Reference Information
| Study Number | Updated Reference Information | Other Changes |
| 23116 | Pharmacy Manual V6 | Atezolizumab stability
Bevacizumab stability and dose changes |
| 23078 | RM930_Protocol_Amendment_v4_20240701_Clean | NA |
| 20345 | XPORT-MF-034 Protocol v5.0-29JUL2024 – | NA |
| 23116 | Protocol – ML44719 – AVASTIN – v5 – Published | NA |
| 23229 | TTX-030-003 IMP Pharmacy Manual_V2.0 | NA |
| 23141 | EFC17757_Prednisone tapering_Memo_1_Final v2.0_29Aug2024 | New prednisone tapering guidelines added |
| 21550 | CABL001AUS08–v02-protocol CABL001AUS08–v02tc-protocol |
NA |
| 24077 | KT-US-484-0136 ZUMA 23 (A-1181-0036) Protocol Amendment 3 Memo | NA |
| 23116 | ML44719 Pharmacy Manual V6.0 _Final Clean_10Jul2024.docx | NA |
| 23066 | Pharmacy Manual_1.0_08 Mar 2023 (2) | NA |
| 23235 | Pharmacy manual Protocol Version 3.0 (06AUG2024) |
NA |
| 21253 | acr-368-201-protocol-v8-5june2024-final- | NA |
| 22311 | Tissue 32 CSP Amd 5 V6.1 Administrative Amendment 12Aug24-Final | NA |
| 22302 | STRO-002-GM3_PCL_-_Dose_Reductions_-_10Sep2024.docx | New doses added to regimes |
| 22124 | BMT54_Protocol_20240904_A06 | NA |