| TIME TRIALS February 2021 Provides You Access to a Network of Just-In-Time Biomarker-Driven Trials for Your Patients
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Your organization has enrolled in the TIME TrialTM Network, which | TIME TRIALS February 2021 provides you access to a network of just-in-time biomarker-driven trials for your patients. Studies currently enrolling in the TIME TrialTM Program: SOLID TUMOR SOLID TUMOR CONT. Elevation ELVAP-001-01 Ideaya IDE196-001 GNAQ/11 hotspot mutation (CRESTONE) Phase I/II At least 1 prior standard therapy; NRG1 fusion Phase II NCT03947385 No prior treatment with a PKC At least 1 prior standard therapy NCT04383210 IDE196 inhibitor Seribantumab Janssen CAN2002 (RAGNAR) FGFR 1-4 fusions & specified Phase II mutations BREAST NCT04083976 At least 1 prior standard therapy JNJ-42756493 (Erdafitinib) Excludes Bladder Cancer HER2-, ER+ & ESR1 mutations Sermonix SMX 18-001 (ELAINE I) Progression following AI in Phase II Turning Point TPX-0005-01 combination with a CDK 4/6 inhibitor; (TRIDENT) NCT03781063 NTRK 1-3 fusions No more than 1 prior systemic Phase II Lasofoxifene or Fulvestrant Allowed up to 2 prior TRK TKIs chemotherapy NCT03093116 TPX-0005 (Repotrectinib) Sermonix SMX 20-001 (ELAINE II) HER2-, ER+ & ESR1 mutations Phase II Progression following first or second- Blueprint BLU-667-101 (ARROW) RET fusion NCT04432454 line hormone therapy; No more than 1 Phase I/II At least 1 prior standard therapy; no Lasofoxifene & Abemaciclib prior systemic chemotherapy NCT03037385 prior treatment with a selective RET Pralsetinib (BLU-667) inhibitor ; Excludes MTC and NSCLC Ayala AL-TNBC-01 (TENACITY) Notch Activation Phase II No more than three lines of systemic Merus MCLA-128-CL01 NCT04461600 therapy; No prior treatment with Phase I/II NRG1 fusion AL101 gamma secretase inhibitors NCT02912949 At least 1 prior standard therapy Zenocutuzumab (MCLA-128) Novellus PLX120-03 Phase I/IIa BRAF mutations NCT02428712 At least 1 prior standard therapy PLX8394 To learn more about the TIME TrialTM Program, please visit our website tempus.com/clinical-trial-matching | TIME TRIALS February 2021 NSCLC GASTRIC/GEJ Janssen EDI1001 (CHRYSALIS) Part A: HER2-; Elevated DKK1 mRNA MET amp & EGFR mutation expression Phase I Progression following EGFR TKI ; NCT02609776 Leap Therapeutics DEK-DKK1- No prior systemic treatment; No prior tx Up to 2 prior systemic chemotherapies with an anti-DKK1 therapy, PD-1, anti- JNJ-61186372 P205 (DisTinGuish) Phase Ila PD-L1, anti-PD-L-2 EMD Serono MS200095-0031 NCT04363801 Part B: Elevated DKK1 mRNA expression (INSIGHT 2) MET amp & EGFR mutation DKN-01 & Tislelizumab No more than 1 prior systemic treatment; Phase II Progression following first-line No prior tx with an anti-DKK1 therapy, PD- NCT03940703 osimertinib 1, anti-PD-L1, anti-PD-L-2 Tepotinib & Osimertinib Calithera CX-839-014 (KEAPSAKE) Phase II LYMPHOMA KEAP1 or NRF2 mutation NCT04265534 No prior systemic treatment in the Telaglenastat or Placebo with Molecular Templates NHL-003 metastatic setting CD20+ B-Cell NHL Pembrolizumab, Carboplatin, Phase IIa Must have received all approved therapies, NCT03645395 Pemetrexed including CD20 targeted therapy MT-3724 & Lenalidomide Turning Point TPX-0005-01 (TRIDENT) ROS1 fusion Phase II Allowed up to 2 prior ROS1 TKIs NCT03093116 Allowed up to 1 prior chemotherapy TPX-0005 (Repotrectinib) Exon 19 deletions (Exon 19del) or Exon Janssen NCS3001 (Mariposa) 21 L858R substitution Phase III No prior systemic treatment in NCT04487080 metastatic setting (adjuvant or Amivantamab or Placebo & neoadjuvant therapy is allowed if more Osimertinib or Lazertinib than 12 months prior to progression) Janssen NCS3003 (Papillon) EGFR Exon 20 ins activating mutation Phase III No prior systemic treatment in NCT03093116 metastatic setting (adjuvant or To learn more about the TIME TrialTM Program, please visit our website Amivantamab, Pemetrexed, & neoadjuvant therapy is allowed if more tempus.com/clinical-trial-matching Carboplatin than 12 months prior to progression) | TIME TRIALS February 2021 PROSTATE Janssen PCR3001 (MAGNITUDE) Phase III BRCA 1/2 mutation NCT03748641 No prior systemic treatment in Niraparib (JNJ-64091742) or Placebo the metastatic setting with Abiraterone Acetate Janssen PCR3002 (AMPLITUDE) BRCA1, BRCA2, BRIP1, CDK12, Phase III CHEK2, FANCA, PALB2, RAD51B, NCT04497844 RAD54L mutation Niraparib (JNJ-64091742) or Placebo No prior treatment with PARP- with Abiraterone Acetate inhibitor Screening for DNA-repair defects Janssen Prevalence for enrollment into Magnitude or Observational (Pre-Screening) Amplitude NCT03871816 No prior treatment with a poly polymerase inhibitor (PARPi) Key INDICATION Sponsor Study Name Phase Target NCT# Prior therapy requirements Study Drugs To learn more or for any questions, please contact Stephanie O’Leary at 715.533.2716 or email stephanie.o'[email protected] ..