Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Carcinoma, Non-Small-Cell Lung

Breast Neoplasms

Prostatic Neoplasms

Lung Neoplasms

Small Cell Lung Carcinoma

Lymphoma

Carcinoma, Neuroendocrine

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Carcinoma

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Small Cell Lung Cancer

Lymphosarcoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Fulvestrant

Patients with NSCLC, SCLC, high-grade neuroendocrine cancer of any primary site, any solid tumors with L-MYC or N-MYC amplification, or DLBCL

Patients with NSCLC with high or low L-MYC or N-MYC expression

Patients with L-MYC or N-MYC amplified solid tumors

Patients with HR-positive, HER2-negative breast cancer in combination with fulvestrant

Patients with prostate cancer in combination with enzalutamide

Oral MRT-2359

Orally administered tablets of MRT-2359 in conjunction with intramuscular administration of fulvestrant.

Orally administered tablets of MRT-2359 in conjunction with orally administered enzalutamide.

Monte Rosa Therapeutics

This Phase 1/2, open-label, multicenter study is conducted in patients with previously treated selected solid tumors, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), high-grade neuroendocrine cancer of any primary site, diffuse large B-cell lymphoma (DLBCL), and tumors with L-MYC or N-MYC amplification. Patients receive escalating doses of a GSPT1 molecular glue degrader MRT-2359 to determine safety, tolerability, maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of MRT-2359. Once the MTD and/or RP2D is identified, additional patients enroll to Phase 2 study, which includes molecular biomarkers stratification or selection, namely expression or amplification of L-MYC and N-MYC genes, hormone receptor positive (HR)-positive, human epidermal growth factor 2 (HER2)-negative breast cancer and prostate cancer.

This Phase 1/2, open-label, multicenter, dose escalation and expansion study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary clinical activity of MRT-2359 in patients with previously treated selected solid tumors, including lung cancer (NSCLC and SCLC), high-grade neuroendocrine cancer of any primary site, and DLBCL.

* The primary aim of Phase 1 part is safety, tolerability, MTD and/or RP2D of MRT-2359.
* The primary aim of Phase 2 part is assessment of preliminary anti-tumor activity of MRT-2359.

Study of Oral MRT-2359 in Selected Cancer Patients

A Phase 1/2 Study of Oral MRT-2359 in Patients With MYC-Driven and Other Selected Solid Tumors Including Lung Cancer and Diffuse B-Cell Lymphoma

Monte Rosa Therapeutics, Inc

Antibodies

Immunoglobulins

All participants receive ORM-5029 in escalating dose cohorts in Part 1 Dose Escalation and at the Expansion Dose Level (EDL) in Part 2 Dose Expansion.

All participants receive ORM-5029 at dose levels with pharmacodynamic activity or efficacy signals (Expansion Cohort A) or at the Expansion Dose Level (EDL) (Expansion Cohorts B and C).

ORM-5029

Orum Therapeutics USA, Inc.

Nusrat Jahan, MD

Nicolaos J Palaskas, MD, PhD

Antonio Giordano, MD, PhD

Katherine Clifton, MD

Massimo Cristofanilli, MD

Erika P Hamilton, MD

Paula Pohlmann, MD, PhD

Sharon T Wilks, MD, FACP

Alex Spira, MD, PhD

This is a Phase 1 first-in-human study of ORM-5029 in participants with HER2-expressing advanced solid tumors. The study consists of two parts: a Part 1 Dose Escalation and Part 2 Dose Expansion.

Study of ORM-5029 in Subjects With HER2-Expressing Advanced Solid Tumors

Phase I Multicenter, Open-Label, First-in-Human Study of ORM-5029 in Subjects With HER2-Expressing Advanced Solid Tumors

Identify the Dose-limiting Toxicities (DLTs) for each dose level tested and determine the MTD and EDL for ORM-5029

Evaluate the safety and tolerability of ORM-5029 by identifying the treatment-emergent adverse events (TEAEs)

ORR is defined as the percentage of subjects with Partial Response (PR) or Complete Response (CR)

DOR is defined as the length of time from the date of the first documented response (PR or CR) until the date of first documented progression or date of death from any cause, whichever came first

CBR is defined as CR + PR + stable disease (SD) up to 4 months

TTR is defined as the length of time from baseline until the date of first documented response (PR or CR)

PFS is defined as the length of time from baseline until the date of first documented progression or date of death from any cause, whichever came first

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Oral MRT-2359 in Selected Cancer Patients	NCT05546268	NSCLC SCLC High Grade Neur... DLBCL L-MYC and N-MYC... NSCLC With High... HR-positive, HE... Prostate Cancer	Oral MRT-2359 Oral MRT-2359 Oral MRT-2359 Oral MRT-2359 Oral MRT-2359 Oral MRT-2359	18 Years -	Monte Rosa Therapeutics, Inc
Study of ORM-5029 in Subjects With HER2-Expressing Advanced Solid Tumors	NCT05511844	HER2-positive B... HER-2 Protein O... HER-2 Gene Ampl... HER2 Gene Mutat...	ORM-5029	18 Years -	Orum Therapeutics USA, Inc.
Study of ORM-5029 in Subjects With HER2-Expressing Advanced Solid Tumors	NCT05511844	HER2-positive B... HER-2 Protein O... HER-2 Gene Ampl... HER2 Gene Mutat...	ORM-5029	18 Years -	Orum Therapeutics USA, Inc.

Spots Global Cancer Trial Database for gspt1

Every month we try and update this database with for gspt1 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 gspt1

Every month we try and update this database with for gspt1 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 gspt1 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.