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

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