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NCT05477576 (RYZ101 in SSTR+ gastroenteropancreatic neuroendocrine tumors): BVCT ex-ante prediction vs. reported outcome

On 25 Aug 2026, BioinvestGPT's BVCT predicted technical partial success and commercial success for this trial. The 12 Oct 2026 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially TBD (pending for OS data).

Clinical Trial

NCTID
NCT05477576
Acronym
ACTION-1
Drug Name
RYZ101
Drug MoA
alpha-emitting radionuclide drug conjugate
Drug Modality
radionuclide drug conjugate
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
SSTR+ gastroenteropancreatic neuroendocrine tumors (GEP-NETs)
Human Patients
343
Sponsor
Bristol Myers Squibb
Phase
Phase 3

Prediction of , index 2179

Prospective Prediction
Prediction Index
2179
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit in OS moderately superior to the SoC arm (everolimus/sunitinib/octreotide/lanreotide) with HR < 0.6 and weakly-to-moderately superior to cabozantinib with HR < 0.7)
Technical Prediction
partial SUCCESS (statistically significant clinical benefit in PFS numerically-to-weakly superior to the SoC arm (everolimus/sunitinib/octreotide/lanreotide) with HR < 0.9 yet non-superior-non-inferior to cabozantinib with 0.9 < HR < 1.1)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
48 days in advance
Readout Data Interpretation
RYZ101 met the primary endpoint PFS with a statistically significant and clinically meaningful improvement superior to the SoC; OS data immature
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially TBD (pending for OS data)
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-11-04. Third-party data.

Official title
Phase 1b/3 Global, Randomized, Controlled, Open-label Trial Comparing Treatment With RYZ101 to Standard of Care Therapy in Subjects With Inoperable, Advanced, SSTR+, Well-differentiated GEP-NETs That Have Progressed Following Prior 177Lu-SSA Therapy
Phase
Phase 3
Status
Active not recruiting
Enrollment
343
Lead sponsor
RayzeBio, Inc.
Conditions
GEP-NET; Gastroenteropancreatic Neuroendocrine Tumor; Gastroenteropancreatic Neuroendocrine Tumor Disease; Neuroendocrine Tumors; Carcinoid; Carcinoid Tumor; Pancreatic NET
Interventions
DRUG: RYZ101; DRUG: Everolimus; DRUG: Sunitinib; DRUG: Octreotide; DRUG: Lanreotide
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2022-03-24
Primary completion
2026-12
Completion
2030-12
Primary outcomes
  • Phase 1b: RP3D (56 days of study treatment)
  • Phase 3: PFS as determined by BICR (After the target number of 143 PFS events have occurred)

NCT05477576 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials