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