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- Actinium-225 DOTATATE (RYZ101) / BMS
Phase 1b portion of the ACTION-1 phase 1b/3 trial of RYZ101 in gastroenteropancreatic neuroendocrine tumors (GEP-NET) progressing after 177 Lu somatostatin analogue (SSA) therapy: Safety and efficacy findings. (Level 1, West Hall; Poster Bd #: F4) - Dec 17, 2024 - Abstract #ASCOGI2025ASCO_GI_558;
P3
Initial data suggest promising efficacy and a manageable safety profile. Part 2 (phase 3) of the ACTION-1 trial is enrolling and will compare RYZ101 at 10.2 MBq every 8 weeks for 4 cycles with standard of care in patients with advanced SSTR2+ GEP-NETs progressing after 177Lu-labeled SSAs.
- Actinium-225 DOTATATE (RYZ101) / BMS
ACTION-1 phase Ib/3 trial of RYZ101 in gastroenteropancreatic neuroendocrine tumors progressing after 177Lu somatostatin analogue therapy: Phase 1b safety/efficacy () - Nov 15, 2024 - Abstract #NANETS2024NANETS_177;
- Keytruda (pembrolizumab) / Merck (MSD), Actinium-225 DOTATATE (RYZ101) / BMS
RYZ101 (225Ac-DOTATATE) (Halls 2-3) - Nov 1, 2024 - Abstract #SABCS2024SABCS_1743;
- |||| Actinium-225 DOTATATE (RYZ101) / BMS
New P1/2 trial, Metastases: TRACY-1: Trial of 225Ac-DOTATATE (RYZ101) Alone and with Pembrolizumab in Subjects with ER+, HER2-negative Unresectable or Metastatic Breast Cancer Expressing SSTRs (clinicaltrials.gov) - Sep 19, 2024
P1/2, N=172, Recruiting, Sponsor: RayzeBio, Inc.
- |||||| Actinium-225 DOTATATE (RYZ101) / BMS
Enrollment open, Metastases: ACTION-1: Study of RYZ101 Compared with SOC in Pts W Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy (clinicaltrials.gov) - Aug 26, 2024
P3, N=288, Recruiting, Sponsor: RayzeBio, Inc.
Part 2 (phase 3) of the ACTION-1 trial is enrolling and will compare RYZ101 at 10.2 MBq every 8 weeks for 4 cycles with standard of care in patients with advanced SSTR2+ GEP-NETs progressing after 177Lu-labeled SSAs. Active, not recruiting --> Recruiting
- Actinium-225 DOTATATE (RYZ101) / BMS, Tecentriq (atezolizumab) / Roche
RYZ101 (225Ac-DOTATATE) + Carboplatin + Etoposide + Atezolizumab in Somatostatin Receptor Expressing Extensive-Stage Small-Cell Lung Cancer (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_1440;
P1
Conclusions : There were no DLTs reported at DL1 (6.5 MBq) and the dose of RYZ101 has been escalated to the next dose level. The study is actively enrolling patients to receive RYZ101 at DL2 (8.3 MBq) and additional safety data will be presented once mature.
- | Actinium-225 DOTATATE (RYZ101) / BMS
Trial primary completion date, Combination therapy: Study of RYZ101 in Combination With SoC in Subjects With SSTR+ ES-SCLC (clinicaltrials.gov) - May 28, 2024
P1, N=31, Recruiting, Sponsor: RayzeBio, Inc.
The study is actively enrolling patients to receive RYZ101 at DL2 (8.3 MBq) and additional safety data will be presented once mature. Trial primary completion date: Apr 2024 --> Mar 2025
- || Actinium-225 DOTATATE (RYZ101) / BMS
New P1 trial: AcTRESS: A Phase I Study to Assess the Tolerability of 225Ac-DOTATATE in Patients With Refractory and Relapsing Multiple Myeloma Expressing Somatostatin Receptors (clinicaltrials.gov) - May 12, 2024
P1, N=30, Not yet recruiting, Sponsor: Jules Bordet Institute
- Actinium-225 DOTATATE (RYZ101) / BMS
Phase Ib portion of the ACTION-1 phase Ib/3 trial of RYZ101 in gastroenteropancreatic neuroendocrine tumors (GEP-NET) progressing after 177Lu somatostatin analogue (SSA) therapy: safety and efficacy findings (801B (Convention Center); In-Person) - May 8, 2024 - Abstract #SNMMI2024SNMMI_1760;
P3
2 MBq was declared the recommended phase 3 dose. Initial data suggest promising efficacy.
- ||||| Actinium-225 DOTATATE (RYZ101) / BMS
Enrollment closed, Metastases: ACTION-1: Study of RYZ101 Compared with SOC in Pts W Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy (clinicaltrials.gov) - Apr 28, 2024
P3, N=288, Active, not recruiting, Sponsor: RayzeBio, Inc.
Initial data suggest promising efficacy. Recruiting --> Active, not recruiting
- Actinium-225 DOTATATE (RYZ101) / BMS
Phase Ib portion of the ACTION-1 phase Ib/3 trial of RYZ101 in gastroenteropancreatic neuroendocrine tumors (GEP-NET) progressing after 177 Lu somatostatin analogue (SSA) therapy: Safety and efficacy findings. (Hall A; Poster Bd #: 236) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2064;
P3
Initial data suggest promising efficacy. Longer-term safety and efficacy data will be presented.
- Actinium-225 DOTATATE (RYZ101) / BMS
Phase classification, Combination therapy: Study of RYZ101 in Combination With SoC in Subjects With SSTR+ ES-SCLC (clinicaltrials.gov) - Apr 9, 2024
P1, N=31, Recruiting, Sponsor: RayzeBio, Inc.
Longer-term safety and efficacy data will be presented. Phase classification: P1b --> P1
- |||| Actinium-225 DOTATATE (RYZ101) / BMS
Trial completion date, Trial primary completion date, Metastases: ACTION-1: Study of RYZ101 Compared with SOC in Pts W Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy (clinicaltrials.gov) - Dec 22, 2023
P3, N=288, Recruiting, Sponsor: RayzeBio, Inc.
- | Actinium-225 DOTATATE (RYZ101) / RayzeBio
Preclinical, Journal: RYZ101 (Ac-225 DOTATATE) Opportunity Beyond Gastroenteropancreatic Neuroendocrine Tumors: Preclinical Efficacy in Small Cell Lung Cancer. (Pubmed Central) - Dec 4, 2023
The anti-tumor effect was further enhanced when RYZ101 was combined with carboplatin and etoposide at clinically relevant doses. In summary, RYZ101 is a highly potent, alpha-emitting radiopharmaceutical agent, and preclinical data demonstrate the potential of RYZ101 for the treatment of patients with SSTR-positive cancers.
- || Actinium-225 DOTATATE (RYZ101) / BMS
Phase classification, Metastases: ACTION-1: Study of RYZ101 Compared with SOC in Pts W Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy (clinicaltrials.gov) - Nov 18, 2023
P3, N=288, Recruiting, Sponsor: RayzeBio, Inc.
In summary, RYZ101 is a highly potent, alpha-emitting radiopharmaceutical agent, and preclinical data demonstrate the potential of RYZ101 for the treatment of patients with SSTR-positive cancers. Phase classification: P1b --> P3
- || Actinium-225 DOTATATE (RYZ101) / BMS
Enrollment change, Metastases: ACTION-1: Study of RYZ101 Compared with SOC in Pts W Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy (clinicaltrials.gov) - Sep 1, 2023
P1b, N=288, Recruiting, Sponsor: RayzeBio, Inc.
Phase classification: P1b --> P3 N=218 --> 288
- Actinium-225 DOTATATE (RYZ101) / RayzeBio
Phase Ib portion of the ACTION-1 phase Ib/3 trial of RYZ101 in gastroenteropancreatic neuroendocrine tumors (GEP-NET) progressing after 177Lu somatostatin analogue (SSA) therapy: Safety and efficacy findings () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2717;
P1b
Initial data suggest promising efficacy. Part 2 (phase 3) is enrolling and will compare RYZ101 at 10.2MBq q8w for 4 cycles with standard of care in pts with advanced SSTR2+ GEP-NETs progressing following prior 177Lu-labeled SSAs.
- RYZ101 / RayzeBio, Tecentriq (atezolizumab) / Roche
RYZ101 + Carboplatin + Etoposide + Atezolizumab in Somatostatin Receptor Expressing Extensive-Stage Small-Cell Lung Cancer (Exhibit Hall) - Jul 25, 2023 - Abstract #IASLCWCLC2023IASLC_WCLC_2359;
P1b
In the dose-expansion portion, a total sample size of n=19 (including patients treated at the MTD/RP2D during the dose-escalation phase) is planned. Approximately 15 sites in the US will participate in the study.
- RYZ101 / RayzeBio
RYZ101 (Ac-225 DOTATATE) Opportunity Beyond GEP-NETs: Preclinical Efficacy in Small Cell Lung Cancer (Exhibit Hall) - Jul 25, 2023 - Abstract #IASLCWCLC2023IASLC_WCLC_1840;
P1b
Preclinical data demonstrate the potential of RYZ101 for the treatment of patients with SSTR+ SCLC. A Phase 1b trial of RYZ101 in combination with atezolizumab, carboplatin, and etoposide is underway in patients with SSTR+ ES-SCLC (NCT05595460).
- RYZ101 / RayzeBio
ACTION-1 phase Ib/3 trial of RYZ101 in somatostatin receptor subtype 2 (Available On Demand; Poster Bd # 453) - Apr 26, 2023 - Abstract #ASCO2023ASCO_1259;
P1b
Part 2 (Phase 3) will commence after Part 1 and will compare RYZ101 at the RP3D with standard of care in pts with advanced SSTR2+ GEP-NETs with disease progression following prior 177Lu-labeled SSAs. Clinical trial information: NCT05477576.
- ||| Actinium-225 DOTATATE (RYZ101) / BMS
Enrollment open, Metastases: ACTION-1: Study of RYZ101 Compared with SOC in Pts W Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy (clinicaltrials.gov) - Apr 21, 2023
P1b, N=218, Recruiting, Sponsor: RayzeBio, Inc.
Clinical trial information: NCT05477576. Active, not recruiting --> Recruiting
- RYZ101 / RayzeBio
Anti-tumor activity of RYZ101 (Ac-225 DOTATATE) in somatostatin receptor-expressing preclinical models of small-cell lung cancer (Section 19; Poster Board #9) - Mar 14, 2023 - Abstract #AACR2023AACR_7272;
P1b
In summary, RYZ101 is a first-in-class, highly potent, ?-emitting radiopharmaceutical therapy being developed for the treatment of SSTR+ solid tumors. Preclinical data demonstrate the potential of RYZ101 for the treatment of patients with SSTR+ SCLC.
- || Actinium-225 DOTATATE (RYZ101) / BMS
Enrollment closed, Metastases: ACTION-1: Study of RYZ101 Compared with SOC in Pts W Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy (clinicaltrials.gov) - Mar 14, 2023
P1b, N=218, Active, not recruiting, Sponsor: RayzeBio, Inc.
Preclinical data demonstrate the potential of RYZ101 for the treatment of patients with SSTR+ SCLC. Recruiting --> Active, not recruiting
- ||| RYZ101 / RayzeBio
RayzeBio Announces Issuance of Two Patents for RYZ101 (225Ac-DOTATATE) https://t.co/Qg9T2rxNZh (Twitter) - Jan 4, 2023
- || Actinium-225 DOTATATE (RYZ101) / BMS
Enrollment open, Combination therapy: Study of RYZ101 in Combination With SoC in Subjects With SSTR+ ES-SCLC (clinicaltrials.gov) - Nov 23, 2022
P1b, N=31, Recruiting, Sponsor: RayzeBio, Inc.
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- RYZ101 / RayzeBio
ACTION-1: A Randomized Phase Ib/3 trial of RYZ101 Compared with SoC in SSTR2+ Well-Differentiated GEP-NET with Progression Following Lu-177 SSA () - Nov 8, 2022 - Abstract #NANETS2022NANETS_122;
Part 2 will commence after Part 1 at ~60 sites in North America, South America, Europe, and Asia. CONCLUSIONS No conclusions; TiP abstract.
- || Actinium-225 DOTATATE (RYZ101) / BMS
New P1 trial, Combination therapy: Study of RYZ101 in Combination With SoC in Subjects With SSTR+ ES-SCLC (clinicaltrials.gov) - Oct 27, 2022
P1b, N=31, Not yet recruiting, Sponsor: RayzeBio, Inc.
- | Actinium-225 DOTATATE (RYZ101) / BMS
New P1 trial, Metastases: ACTION-1: Study of RYZ101 Compared with SOC in Pts W Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy (clinicaltrials.gov) - Jul 28, 2022
P1b, N=218, Recruiting, Sponsor: RayzeBio, Inc.