Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Pancreatic Neoplasms

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

HBI-2376 will be given orally in ascending doses (escalation cohort), until the maximum tolerated dose or recommended Phase 2 dose is reached. Up to 6 patients will then be enrolled in the expansion cohort at the recommended dose.

HBI-2376

John Ning, MD,PhD,FAIC

Susan Hmwe

Ravi Salgia, MD

Christina Spencer

Alberto Bessudo, MD

Noli Raz

David J Park, MD

Victoria S Chua-Alcala, MD, CLS

Sant Chawla, MD

Joanna Gutierrez

Jonathan Goldman, MD

Kiera Grofsik

Sajeve Thomas, MD

Ines Padron

Harshad Amin, MD

Kim Roby

Nashat Gabrail, MD

Penny Watkins, RN

Donald A Richards, MD, PhD

Cynthia DeLeon

Alexander Spira, MD, PhD

Marcia R Cruz-Correa, MD,PhD,AGAF,FASGE

A Phase 1 dose escalation study in patients with advanced solid tumors harboring KRAS or EGFR mutations to determine the maximum tolerated dose and recommended Phase II dose of HBI-2376 and characterize its pharmacokinetic profile.

A Phase 1, Open-Label, Dose Escalation of HBI-2376 in Patients with Advanced Malignant Solid Tumors Harboring KRAS or EGFR Mutations. The primary and secondary objectives are:

1. To determine the MTD and recommended Phase 2 dose (RP2D), of HBI-2376 as an oral monotherapy for advanced solid tumors harboring KRAS or EGFR mutations
2. To characterize the PK of HBI-2376 in subjects with advanced malignant solid tumors harboring KRAS or EGFR mutations

HBI-2376 is a SHP2 Inhibitor and will be dosed once daily throughout the escalation and expansion phase. Up to 42 subjects will be enrolled sequentially into the 3+3 dose escalation and monitored throughout the study for safety and tolerability. The dose escalation phase will consist of 6 cohorts, with doses ranging from 6 to 40mg. Once the MTD of RP2D is established, additional 6 subjects will be enrolled into the expansion phase at that dose level.

3+3 Dose Escalation Design with Expansion

A Dose Escalation Study of SHP2 Inhibitor in Patients With Solid Tumors Harboring KRAS of EGFR Mutations

A Phase 1, Open-Label, Dose Escalation of HBI-2376 in Patients With Advanced Malignant Solid Tumors Harboring KRAS or EGFR Mutations

Safety endpoints: Incidence of dose-limiting toxicities (DLTs), adverse events (AEs), and serious adverse events (SAEs) overall, by severity, by relationship to HBI-2376, and those that led to discontinuation of HBI-2376

Pharmacokinetic variables including maximum plasma concentration (Cmax)

Pharmacokinetic variables including minimum plasma concentration (Cmin)

Pharmacokinetic variables including Area Under the Curve (AUC)

Pharmacokinetic variables including clearance

Pharmacokinetic variables including serum half-life

Pharmacokinetic variables including volume of distribution

HUYABIO International, LLC.

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

mRNA-2736

This study is designed to evaluate the safety and tolerability of mRNA-2736 in participants with RRMM.

This open-label, Phase 1, dose-escalation, first-in-human (FIH) clinical study of mRNA-2736 in participants with RRMM is designed to evaluate the safety and tolerability of escalating doses of mRNA-2736, administered intravenously (IV), to determine maximum tolerated dose and/or recommended Phase 2 dose, pharmacokinetics, pharmacodynamics, and preliminary efficacy of mRNA-2736.

mRNA-2736 for Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

A Phase 1, Open-Label, Multicenter, Study of mRNA-2736 in Patients With Relapsed or Refractory Multiple Myeloma

ModernaTX, Inc.

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

HBI-2438 will be given orally in ascending doses (escalation cohort), until the maximum tolerated dose or recommended Phase 2 dose is reached. Up to 6-8 patients will then be enrolled in the expansion cohort at the recommended dose.

HBI-2438

Leslie Posadas

Amitabha Mazumder, MD

Rameez Umer

Richard P Zekman, DO

Jennifer Ross

Jaswinder Singh, MD

Maria R Cruz-Correa, MD,PhD,AGAF,FASGE

A Phase 1 dose escalation study in patients with advanced solid tumors harboring KRAS G12C mutation to determine the maximum tolerated dose and recommended Phase II dose of HBI-2438 and characterize its pharmacokinetic profile.

A Phase 1, Open-Label, Dose Escalation of HBI-2438 in Patients with Advanced Malignant Solid Tumors Harboring KRAS G12C Mutation. The primary and secondary objectives are:

1. To determine the MTD and recommended Phase 2 dose (RP2D) of HBI-2438 as an oral monotherapy for advanced solid tumors harboring KRAS G12C mutation.
2. To characterize the PK of HBI-2438 in subjects with advanced malignant solid tumors harboring KRAS G12C mutation.

HBI-2438 is an orally administered KRAS G12C Inhibitor and will be dosed once daily throughout the escalation and expansion phase. Up to 44 subjects will be enrolled sequentially into the 3+3 dose escalation and monitored throughout the study for safety and tolerability. The dose escalation phase will consist of 6 cohorts, with doses ranging from 150 to 1200mg. Once the MTD of RP2D is established, an additional 6-8 subjects with brain metastases will be enrolled into the expansion phase at that dose level.

A Dose Escalation Study of HBI-2438 in Patients With Solid Tumors Harboring KRAS G12C Mutation

A Phase 1, Open Label, Dose Escalation of HBI-2438 in Patients With Advanced Malignant Solid Tumors Harboring KRAS G12C Mutation

Safety endpoints: Incidence of dose-limiting toxicities (DLTs)

Safety endpoints: adverse events (AEs), and serious adverse events (SAEs) overall

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Dose Escalation Study of SHP2 Inhibitor in Patients With Solid Tumors Harboring KRAS of EGFR Mutations	NCT05163028	Non Small Cell ... Colorectal Canc... Pancreatic Canc... Solid Tumor Cancer Cancer of Pancr... Cancer of Colon	HBI-2376	18 Years -	HUYABIO International, LLC.
mRNA-2736 for Participants With Relapsed or Refractory Multiple Myeloma (RRMM)	NCT05918250	Relapsed or Ref...	mRNA-2736	18 Years -	ModernaTX, Inc.
mRNA-2736 for Participants With Relapsed or Refractory Multiple Myeloma (RRMM)	NCT05918250	Relapsed or Ref...	mRNA-2736	18 Years -	ModernaTX, Inc.
A Dose Escalation Study of HBI-2438 in Patients With Solid Tumors Harboring KRAS G12C Mutation	NCT05485974	Lung Cancer Non Small Cell ... Colorectal Canc... Cancer of Pancr... Colon Cancer Solid Tumor Cancer	HBI-2438	18 Years -	HUYABIO International, LLC.
A Dose Escalation Study of SHP2 Inhibitor in Patients With Solid Tumors Harboring KRAS of EGFR Mutations	NCT05163028	Non Small Cell ... Colorectal Canc... Pancreatic Canc... Solid Tumor Cancer Cancer of Pancr... Cancer of Colon	HBI-2376	18 Years -	HUYABIO International, LLC.

Spots Global Cancer Trial Database for fih

Every month we try and update this database with for fih 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 fih

Every month we try and update this database with for fih 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 fih 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.