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Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy

ConditionsGEP-NETGastroenteropancreatic Neuroendocrine TumorGastroenteropancreatic Neuroendocrine Tumor DiseaseNeuroendocrine TumorsCarcinoidCarcinoid TumorPancreatic NET
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorRayzeBio, Inc.

About this trial

This study aims to determine the safety, pharmacokinetics (PK) and recommended Phase 3 dose (RP3D) of RYZ101 in Part 1, and the safety, efficacy, and PK of RYZ101 compared with investigator-selected standard of care (SoC) therapy in Part 2 in subjects with inoperable, advanced, well-differentiated, somatostatin receptor expressing (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have progressed following treatment with Lutetium 177-labelled somatostatin analogue (177Lu-SSA) therapy, such as 177Lu-DOTATATE or 177Lu-DOTATOC (177Lu-DOTATATE/TOC), or 177Lu-high affinity \[HA\]-DOTATATE.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically proven, Grade 1-2 well differentiated, inoperable, advanced GEP-NETs (Ki67 ≤20%) Eastern Cooperative Oncology Group (ECOG) status 0-2. Ki67% <20% is not required for the ad hoc subcohort of the PK/ECG substudy.

Progressive, SSTR-PET positive (i.e., Krenning score 3 or 4) GEP-NET (GI or pancreas) following 2-4 cycles of treatment with 177Lu-labeled SSA. Must have achieved disease control for at least 6 months following Lu-177 SSA (archival tissue is not required for the ad hoc subcohort of the PK/ECG substudy). No time limit is defined between 177Lu-SSA treatment and randomization. There must be at least 1 SSTR-PET imaging-positive measurable site of disease (according to RECIST v1.1) and no RECIST v1.1 measurable metastatic lesions that are SSTR imaging-negative.

Adequate renal function, as evidenced by estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m2 (calculated using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]) (Levey et al. 2009)

Part 2: Hemoglobin concentration ≥5.0 mmol/L (≥8.0 g/dL); ANC ≥1000 cells/µL (≥1000 cells/mm3); platelets ≥75 x 109/L (75 x 103/mm3).

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • RYZ101

    Drug

    RP3D as determined in Phase 1b

  • Everolimus

    Drug

    Everolimus

  • Sunitinib

    Drug

    Sunitinib

  • Octreotide

    Drug

    High-dose octreotide

  • Lanreotide

    Drug

    Lanreotide

Treatment groups

338 Participants
are divided into 4 treatment groups
Group A: Phase 1b - RYZ101Experimental treatment 1 intervention
Group B: Phase 3 - RYZ101Active comparator 1 intervention
Group C: Phase 3 - Standard of CareActive comparator 4 interventions
Group D: Phase 3 - RYZ101, PK/ECG Substudy adhoc subcohortActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Phase 1b: RP3D

Incidence of DLTs during the first 56 days of study treatment will be assessed.

Time frame
56 days of study treatment
2

Phase 3: PFS as determined by BICR

PFS will be defined as the time from the date of randomization until the date of progression (as determined by BICR from tumor assessments using RECIST v1.1) or death due to any cause, whichever occurs earlier.

Time frame
After the target number of 143 PFS events have occurred

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RayzeBio, Inc.

Lead sponsor

Source ClinicalTrials.gov
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