June 2025 SCRI Release Copied
SCRI Trials and Trial Regimen Updates
The following updates were completed between May 17, 2025, through June 19, 2025. Sarah Cannon Research Institute now manages all SCRI/USOR trials and trial regimens.
For questions about these trials and regimens, please contact SCRIiKMEMRedits@McKesson.com.
New Builds Completed
| Study Number | Notes for New Build |
| 24179 | USOR 24179 BMT 56 Phase 2 Vimselitinib Q28D |
| 23165 | USOR 23165 GI 356 Phase 2 Part B FOLFIRI Q28D – v2.1 01MAR2024
USOR 23165 GI 356 Phase 2 Part B FOLFOX Q28D – v2.1 01MAR2024 USOR 23165 GI 356 Phase 2 Part B Tinengotinib Q28D – v2.1 01MAR2024 |
| 24250 | USOR 24250 LUN 583 Phase 1b/2 Part 1 Telisotuzumab Adizutecan + Budigalimab Q21D
USOR 24250 LUN 583 Phase 1b/2 Part 2 Arm 3 Budigalimab + Pemetrexed + Carboplatin fb Budigalimab + Pemetrexed Q21D USOR 24250 LUN 583 Phase 1b/2 Part 2 Arm 3 Budigalimab + Pemetrexed + Cisplatin fb Budigalimab + Pemetrexed Q21D USOR 24250 LUN 583 Phase 1b/2 Part 2 SOC Arm Pembrolizumab + Pemetrexed + Carboplatin fb Pembrolizumab + Pemetrexed Q21D USOR 24250 LUN 583 Phase 1b/2 Part 2 SOC Arm Pembrolizumab + Pemetrexed + Cisplatin fb Pembrolizumab + Pemetrexed Q21D |
| 24326 | USOR 24326 GI 394 Ph1b Arm A1/A2 Toripalimab-tpzi + CHS-114 Q21D |
| 23309 | USOR 23309 BRE 439 Phase 3 Arm 1 MK-2870 + Pembrolizumab Q42D 24Jan2025
USOR 23309 BRE 439 Phase 3 Arm 2 Pembrolizumab +/- Capecitabine Q42D 24Jan2025 |
| 24234 | USOR 24234 GI 391 Phase 2 Arm A Casdozokitug + Toripalimab + Bevacizumab Q21D
USOR 24234 GI 391 Phase 2 Arm B Casdozokitug + Toripalimab + Bevacizumab Q21D USOR 24234 GI 391 Phase 2 Arm C Toripalimab + Bevacizumab Q21D |
| 24155 | USOR 24155 GI 385 Phase 3 Arm A Amivantamab + mFOLFOX6 Q28D
USOR 24155 GI 385 Phase 3 Arm A Amivantamab + FOLFIRI Q28D USOR 24155 GI 385 Phase 3 Arm B Cetuximab D1,15 + FOLFIRI Q28D USOR 24155 GI 385 Phase 3 Arm B Cetuximab D1,15 + mFOLFOX6 Q28D USOR 24155 GI 385 Phase 3 Arm B Cetuximab D1,8,15,22 + FOLFIRI Q28D USOR 24155 GI 385 Phase 3 Arm B Cetuximab D1,8,15,22 + mFOLFOX6 Q28D |
| 23269 | USOR 23269 RM 1032 Phase 1/2 Part 1a AVZO-021 Q28D
USOR 23269 RM 1032 Phase 1/2 Part 1a Food Effect Substudy AVZO-021 D‑4,‑2 USOR 23269 RM 1032 Phase 1/2 Part 1b Cohort B1 AVZO-021 + Fulvestrant Q28D USOR 23269 RM 1032 Phase 1/2 Part 1b Cohort B2 AVZO-021 + Palbociclib + Endocrine Therapy Q28D USOR 23269 RM 1032 Phase 1/2 Part 1b Cohort B3 AVZO-021 + Ribociclib + Endocrine Therapy Q28D USOR 23269 RM 1032 Phase 1/2 Part 1b Cohort B4 AVZO-021 + Abemaciclib + Endocrine Therapy Q28D USOR 23269 RM 1032 Phase 1/2 Part 1b Cohort B5 AVZO-021 + Sacituzumab Govitecan-hziy Q28D USOR 23269 RM 1032 Phase 1/2 Part 1b Cohort C AVZO-021 + Carboplatin Q28D USOR 23269 RM 1032 Phase 1/2 Part 2a AVZO-021 Q28D |
| 23322 | USOR 23322 LUN 563 Phase 3 Arm 1 Dato-DXd + Rilvegostomig Q21D
USOR 23322 LUN 563 Phase 3 Arm 2 Rilvegostomig Q21D USOR 23322 LUN 563 Phase 3 Arm 3 Pembrolizumab Q21D |
| 24240 | USOR 24240 MULTI 95 Phase 1 Part 2 (Cohorts 3,4,5) VT3989 Q28D
USOR 24240 MULTI 95 Phase 1 Part 3 Cohort A Safety Lead-In VT3989 + Nivolumab + Ipilimumab Q42D USOR 24240 MULTI 95 Phase 1 Part 3 Cohort A VT3989 + Nivolumab + Ipilimumab Q42D USOR 24240 MULTI 95 Phase 1 Part 3 Cohort B Safety Lead-In VT3989 + Osimertinib Q28D USOR 24240 MULTI 95 Phase 1 Part 3 Cohort B VT3989 + Osimertinib Q28D |
| 24267 | USOR 24267 LYM 250 Phase 3 Zanubrutinib + Sonrotoclax or Placebo Q28D |
| 24310 | USOR 24310 GU 256 Phase 1/1b Food Effect Sub-Study (Cohort F) ORIC-944 (D-7) + Darolutamide (D-6)
USOR 24310 GU 256 Phase 1/1b Food Effect Sub-Study (Cohort F) ORIC-944 + Darolutamide Q28D USOR 24310 GU 256 Phase 1/1b Part 3 (Cohorts A and C) Lead-in ORIC-944 (D-7) + Apalutamide (D-6) USOR 24310 GU 256 Phase 1/1b Part 3 (Cohorts A and C) ORIC-944 + Apalutamide Q28D USOR 24310 GU 256 Phase 1/1b Part 3 (Cohorts B and D) Lead-in ORIC-944 (D-7) + Darolutamide (D-6) USOR 24310 GU 256 Phase 1/1b Part 3 (Cohorts B and D) ORIC-944 + Darolutamide Q28D |
| 23251 | USOR 23251 BRE 442 Phase 3 Arm 1 Saruparib + Camizestrant Q28D – v2.0 30JAN2024
USOR 23251 BRE 442 Phase 3 Arm 2 CDK4/6i + ET Q28D – v2.0 30JAN2024 USOR 23251 BRE 442 Phase 3 Arm 3 Camizestrant + CDK4/6i Q28D – v2.0 30JAN2024 |
| 24064 | USOR 24064 MULTI 90 Phase 1b Zongertinib + T-DM1 Q21D – v4.0 25FEB2025
USOR 24064 MULTI 90 Phase 1b Zongertinib + T-DXd Q21D – v4.0 25FEB2025 USOR 24064 MULTI 90 Phase 1b Zongertinib + Trastuzumab + Capecitabine Q21D – v4.0 25FEB2025 USOR 24064 MULTI 90 Phase 1b Zongertinib + Trastuzumab Q21D – v4.0 25FEB2025 |
| 24301 | USOR 24301 BRE 452 Phase 2 All Arms Adjuvant T-DM1 Q21D – 28APR2025
USOR 24301 BRE 452 Phase 2 Arm A Neoadjuvant Zanidatamab + Paclitaxel Q21D – 28APR2025 USOR 24301 BRE 452 Phase 2 Arm B Neoadjuvant Zanidatamab + Docetaxel + Carboplatin Q21D – 28APR2025 USOR 24301 BRE 452 Phase 2 Arm C Adjuvant Trastuzumab +/- Pertuzumab Q21D – 28APR2025 USOR 24301 BRE 452 Phase 2 Arm C Neoadjuvant Trastuzumab + Pertuzumab + Docetaxel + Carboplatin Q21D – 28APR2025 USOR 24301 BRE 452 Phase 2 Arms A and B Adjuvant Zanidatamab Q21D – 28APR2025 |
Updated Reference Information
| Study Number | Updated Reference Information | Updated Regimen Instructions | Other Changes |
| 23120 | N/A | N/A | Added monotherapy regimen |
| 23239 | Amendment 06: 03 Mar 2025 | N/A | N/A |
| 23190 | Amendment 03: 12 Sep 2024 | N/A | Updated premedication |
| 23085 | Amendment 3.0: 08JAN2025 | N/A | Added new regimen |
| 23297 | (Subprotocol A) Amendment 4: 29 Jan 2025 (Master Protocol) Amendment 4: 29 Jan 2025 |
N/A | Updated premedication instruction. |
| 23294 | N/A | N/A | Drug procurement updated |
| 23190 | N/A | N/A | Drug procurement updated |
| 23292 | Amendement v18: 24 Feb 2025 | N/A | Added New Cohort |
| 24004 | Amendment V4.0: 14 FEB 2025 | Updated observation wording | Updated drug preparation |
| 22249 | Amendment v6.0: 27 Nov 2024 | N/A | Updated order of administration |
| 23288 | N/A | N/A | Updated drug procurement |
| 23243 | N/A | N/A | Updated drug procurement |
| 24093 | Version 3.0: 29 Nov 2024 | N/A | Updated drug instruction |
| 24130 | N/A | N/A | Updated drug preparation |
| 24153 | N/A | N/A | Updated drug formulation |
| 23307 | Sub B PA3: 24 Jan 2025 | N/A | N/A |
| 23273 | Amendment 4 Version 5.0 | N/A | Updated drug administration |
| 23049 | PA V4: 12 AUGUST 2024 | N/A | N/A |
| 23288 | a3, v4.0: 14Mar2025 | N/A | Updated infusion time.
Added new cohort |
| 24146 | N/A | N/A | Updated drug instructions. |
| 24068 | PA v4.0: 13 Mar 2025 | N/A | Updated drug instructions. |
| 21270 | PA V8.0: 24 Jan 2025 | N/A | N/A |
| 23223 | Version 7.0: 02 Apr 2025; Local Amendment 05: 07 Apr 2025 | N/A | Updated drug name |
| 21533 | PA5 v6.0: 22 Jan 2025 | N/A | Added new regimen |
| 22252 | Master PA5: 14 Nov 2024 | N/A | N/A |
| 24014 | PA1: 31 Mar 2025 | N/A | Updated drug instructions. |
| 24099 | Version 4.0, 29APR2025 | N/A | Update administration instruction |
| 22026 | N/A | N/A | Updated drug name |
| 24050 | N/A | N/A | New phase open |
| 24111 | PA3.0: 28 Feb 2025. | N/A | N/A |
| 24004 | N/A | N/A | Updated stability |
| 22159 | N/A | N/A | Updated drug administration |
| 23170 | Version 5, 24APR2025 | N/A | Added new regimen |
| 23129 | Version 5.0, 29APR2025 | N/A | Added standard wording to drug instructions |
| 24070 | Memo, 07APR2025 | N/A | Updated drug dose |
