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News
Tam-Peli meets primary endpoint for relapsed small-cell lung cancer in phase III trial
1+ day, 2+ hour ago (401+ words) The Clinical Trial Vanguard Tam-Peli meets primary endpoint for relapsed small-cell lung cancer in phase III trial Topotecan has been the default second-line chemotherapy for relapsed small-cell lung cancer for decades, and its survival benefit in that setting is modest…...
CMO Location Drives Site Selection for Parkinsonian Imaging Trial
1+ day, 2+ hour ago (171+ words) clinicaltrialvanguard.com CMO Location Drives Site Selection for Parkinsonian Imaging Trial When a radiopharmaceutical expires within hours of manufacture, the drug’s chemistry, not the disease’s prevalence, decides where a trial can run. That constraint shaped every decision in a site…...
Insilico Medicine Begins Phase III Trial of AI-Discovered Drug Rentosertib for IPF
4+ day, 2+ hour ago (422+ words) The Clinical Trial Vanguard Insilico Medicine Begins Phase III Trial of AI-Discovered Drug Rentosertib for IPF Rentosertib just cleared a threshold no AI-discovered drug has reached before: 320 patients, 47 sites, 52 weeks of treatment in a randomized, double-blind, placebo-controlled Phase III. Insilico Medicine…...
Novartis Pays $50M Milestone as MRT-6160 Enters Phase 2 for Sjögren’s Disease
5+ day, 2+ hour ago (336+ words) The Clinical Trial Vanguard Novartis Pays $50M Milestone as MRT-6160 Enters Phase 2 for Sjögren’s Disease A $50 million check is the clearest signal yet that Novartis believes VAV1 degradation works in humans. Monte Rosa Therapeutics triggered that milestone payment on September 8, 2026, when Novartis…...
BridgeBio Shifts BBO-8520 Focus to KRAS Combinations in Second-Line NSCLC
5+ day, 2+ hour ago (322+ words) The Clinical Trial Vanguard BridgeBio Shifts BBO-8520 Focus to KRAS Combinations in Second-Line NSCLC A 63% objective response rate from a Phase 1 monotherapy arm is an unusual number to anchor a strategic pivot on, but that is what BridgeBio Oncology Therapeutics…...
A 25% Sample Size Cut Sounds Like a Win, Until You See the Amendment Queue
5+ day, 1+ hour ago (790+ words) The Clinical Trial Vanguard A 25% Sample Size Cut Sounds Like a Win, Until You See the Amendment Queue A clinical operations lead gets the news from her biostatistics team: the new digitally enhanced composite endpoint just cut the required sample…...
Tekton Research Sites Enroll 60 Participants in Phase 2 Obesity Trial, Triple Goal
1+ week, 2+ hour ago (334+ words) The Clinical Trial Vanguard Tekton Research Sites Enroll 60 Participants in Phase 2 Obesity Trial, Triple Goal Enrolling three times the planned number of participants is rare enough that it usually points to something structural, not just enthusiasm. Tekton Research’s San Antonio…...
FDA Guidance Expands Cancer Trial Eligibility, Reshaping Feasibility Models
1+ week, 1+ day ago (383+ words) The Clinical Trial Vanguard FDA Guidance Expands Cancer Trial Eligibility, Reshaping Feasibility Models Forty percent of Phase III cancer trials explicitly barred patients with an ECOG performance status of 2 or higher, and among trials that allowed those patients, they made…...
Ultragenyx’s apazunersen fails Phase 3 primary endpoint in Angelman syndrome
1+ week, 4+ day ago (527+ words) The Clinical Trial Vanguard Ultragenyx’s apazunersen fails Phase 3 primary endpoint in Angelman syndrome Two years of Phase 1/2 momentum collapsed in a single readout: Ultragenyx’s Phase 3 Aspire study for apazunersen (GTX-102) in Angelman syndrome failed both its primary endpoint and its…...
NSABP B-59 Failed. The Real Question Is Why We Keep Designing Trials That Can’t Detect the Signal.
1+ week, 4+ day ago (198+ words) That failure carries weight far beyond the TNBC space. Every immuno-oncology sponsor running a Phase 3 program with a PD-L1 inhibitor, in any indication, should be reading the B-59 readout and asking a harder question than “did it work?” The harder question…...