Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Neuroendocrine Tumors

Carcinoid Tumor

Intestinal Neoplasms

Pancreatic Neoplasms

Stomach Neoplasms

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Stomach Diseases

Neuroendocrine Tumor

Gastro-enteropancreatic Neuroendocrine Tumor

Pancreatic Neuroendocrine Tumor

Pancreatic Cancer

Stomach Cancer

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Gastrointestinal Agents

Anti-Infective Agents

Everolimus

Somatostatin

Sunitinib

Octreotide

Lanreotide

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Antineoplastic Agents, Hormonal

Part 1 is an uncontrolled dose de-escalation study to confirm the safety and determine the RP3D of RYZ101 based on Bayesian optimal interval design. Eligible participants will be enrolled in cohorts of 6 to receive RYZ101 up to 4 infusions every 8 weeks. If the initial dose level is not tolerated, the dose will be de-escalated; up to 3 dose levels will be assessed.

Actinium 225 radiolabeled somatostatin analog (SSA) for injection

Investigator's choice of standard of care between everolimus, sunitinib, octreotide, or lanreotide.

RYZ101

Everolimus 10 mg

Sunitinib 37.5 MG

High-dose octreotide LAR 60 mg Q4W by i.m. injection

Octreotide LAR 60 MG Injection

High dose frequency lanreotide 120 mg Q2W by deep s.c. injection

Lanreotide 120Mg Sa Susp Inj Syringe

Denis Ferreira, MD

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.

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

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

Incidence and severity of AEs by NCI CTCAE v5, including SAEs, laboratory changes, ECG changes, and other safety findings

Relationship between biomarkers, including but not limited to CgA in the serum and (5-HIAA) in the urine, with AEs of special interest and/or efficacy endpoints (e.g., PFS, OS, BOR, DoR)

Measured by continuous ECG recording using a 12-lead Holter monitoring device

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

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.

Calculated mean TIAC (hours) and absorbed radiation dose coefficients (mGy/MBq) to critical organs (e.g., the kidneys and bone marrow) and tumors after the 1st and 4th RYZ101 infusions will be assessed

OS will be defined as the time from the date of randomization until the date of death due to any cause.

ORR, as determined by BICR according to RECIST v1.1.

ORR, as assessed by the Investigator according to RECIST v1.1

Assessed by BICR and by the Investigator according to RECIST v1.1

Only for subjects with a RECIST v.1.1 response, assessed by BICR and by the Investigator according to RECIST v1.1

RayzeBio, Inc.

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Small Cell Lung Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Small Cell Lung Cancer

Etoposide

Carboplatin

Atezolizumab

Etoposide phosphate

Radiopharmaceuticals

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

RYZ101 (Actinium 225 radiolabeled somatostatin analog (SSA)) 6.5 MBq/175 μCi in combination with standard of care (SoC) carboplatin + etoposide + atezolizumab

6.5 MBq/175 μCi administered by IV for up to 6 infusions once every 4 or 6 weeks

RYZ101 Dose Level 1

8.3 MBq/225 μCi administered by IV for up to 6 infusions once every 4 or 6 weeks

RYZ101 Dose Level 2

10.2 MBq/275 μCi administered by IV for up to 6 infusions once every 4 or 6 weeks

RYZ101 Dose Level 3

4.6 MBq/125 μCi administered by IV for up to 6 infusions once every 4 or 6 weeks

RYZ101 Dose Level -1

1200 mg administered IV for 4 x 21-day cycles, followed by 1680 mg every 28-days (maintenance)

AUC 5-6 administered IV for 4 x 21-day cycles

80-100 mg/m2 administered IV on 3 consecutive days for 4 x 21-day cycles

RayzeBio Clinical Trials

Jonathan Goldman

Megan Gee

Claire Mulvey, MD

Ephraim Parent, MD

Caitlin Mynard

Justin Rineer, MD

Mark Crystal

Manish Thakur, MD

Heather Austin

Krisha Howell, MD

Aaron Mansfield, MD

Marlene Bridwell

Robert Langdon, MD

John Waldron

John Waldron, MD

Sonam Puri, MD

Iris G. Garcia-Acevedo, BSN-RN

Noridza Rivera-Rodriguez, MD

Denise Ferreira, MD

This study aims to determine the safety, preliminary antitumor activity, and pharmacokinetics (PK) of RYZ101 in combination with standard of care (SoC) therapy consisting of carboplatin + etoposide + atezolizumab in untreated subjects with somatostatin receptor expressing (SSTR+) ES-SCLC.

Study of RYZ101 in Combination With SoC in Subjects With SSTR+ ES-SCLC

Phase 1b Single Arm, Open-label Trial of RYZ101 in Combination With Carboplatin + Etoposide + Atezolizumab in Subjects With Somatostatin Receptor Expressing (SSTR+) Extensive Stage Small Cell Lung Cancer (ES-SCLC)

RP2D as determined by incidence rate of DLTs

Safety and tolerability of RYZ101 in combination with SoC as measured by incidence and severity of AEs including SAEs, laboratory changes and other safety findings

Durable ORR defined as the proportion of subjects with measurable disease at baseline who achieve confirmed CR or PR according to RECIST v1.1 lasting at least 4 months

ORR as assessed by the Investigator according to RECIST v1.1

Only for subjects with a RECIST v.1.1 response, assessed by the Investigator according to RECIST v1.1

OS as defined from the time of first dose of RYZ101 or first dose of SoC therapy to the date of death due to any cause

BOR as assessed by the Investigator according to RECIST v1.1

Disease control rate (PR + CR + SD) as assessed by the Investigator according to RECIST v1.1

PFS as defined from date of first dose of RYZ101 or first dose of SoC therapy to the date of progression as assessed by the Investigator according to RECIST v1.1

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy	NCT05477576	GEP-NET Gastroenteropan... Gastroenteropan... Neuroendocrine ... Carcinoid Carcinoid Tumor Pancreatic NET	RYZ101 Everolimus 10 m... Sunitinib 37.5 ... Octreotide LAR ... Lanreotide 120M...	18 Years -	RayzeBio, Inc.
Study of RYZ101 in Combination With SoC in Subjects With SSTR+ ES-SCLC	NCT05595460	SCLC,Extensive ...	RYZ101 Dose Lev... RYZ101 Dose Lev... RYZ101 Dose Lev... RYZ101 Dose Lev... Atezolizumab Carboplatin Etoposide	18 Years -	RayzeBio, Inc.

Spots Global Cancer Trial Database for ryz101

Every month we try and update this database with for ryz101 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ryz101

Every month we try and update this database with for ryz101 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ryz101 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.