MPT-0118 / Monopteros Therap - LARVOL DELTA

First-in-human study of MALT1 inhibitor MPT-0118: Results from monotherapy dose escalation in advanced or metastatic refractory solid tumors (ESMO 2023) - P1 | "Clinical trial identification NCT04859777. The biomarker data are consistent with the purported mechanism. The results warrant advancing to study Part B in combination with pembrolizumab."

IO biomarker • Metastases • Monotherapy • P1 data • Breast Cancer • Chordoma • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CD8 • IFNG • MALT1 • PD-L1

Translational Studies Using the MALT1 Inhibitor (S)-Mepazine to Induce Treg Fragility and Potentiate Immune Checkpoint Therapy in Cancer. (PubMed, J Immunother Precis Oncol) - P1 | "Activity in syngeneic tumor models and human PDOTS was likely mediated by induction of tumor-associated Treg fragility. This translational study supports ongoing clinical investigations (ClinicalTrials.gov Identifier: NCT04859777) of MPT-0118, (S)-mepazine succinate, in patients with advanced or metastatic treatment-refractory solid tumors."

Journal • Immune Modulation • Oncology • Solid Tumor • MALT1

Reprogramming regulatory T cells (Treg) using a MALT1 inhibitor for cancer therapy (SITC 2021) - P1, P1b | "MPT-0118 exploits the therapeutic opportunity presented by destabilized Treg in the TME. Treg reprogramming represents a novel strategy with the potential to improve responses to ICB therapy in a broad range of solid tumors."

Colorectal Cancer • Endometrial Cancer • Gastrointestinal Cancer • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor • IFNG • MALT1

[VIRTUAL] MPT-0118 a clinical drug candidate to assess Treg reprogramming via MALT1 blockade (ESMO 2021) - P1 | "MPT-0118 Treg reprogramming represents a novel strategy with the potential to mitigate the critical problem of low ICT response rates in solid tumors. MPT-0118 recently started a phase 1/1b dose-escalation and cohort-expansion clinical trial."

Clinical • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • IFNG • MALT1

First-in-human study of MALT1 inhibitor MPT-0118 as monotherapy and in combination with pembrolizumab in advanced or metastatic refractory solid tumors: Single-agent dose escalation results (AACR-NCI-EORTC 2022) - No abstract available

Combination therapy • Monotherapy • P1 data • Oncology • Solid Tumor • MALT1

A Study of MPT-0118 in Subjects With Advanced or Metastatic Refractory Solid Tumors (clinicaltrials.gov) - P1; N=70; Recruiting; Sponsor: Monopteros Therapeutics Inc.

Clinical • Combination therapy • Monotherapy • New P1 trial • Oncology • Solid Tumor

Monopteros Therapeutics Announces Two Presentations at the Tumor Immune Microenvironment Workshop of the Society for Immunotherapy of Cancer (SITC) (Businesswire) - "Monopteros Therapeutics Inc...announced two presentations at the tumor immune microenvironment workshop of the Society for Immunotherapy of Cancer (SITC), to be held in person in San Diego and virtually from April 21-22, 2022. These presentations demonstrate that highly activated immunosuppressive regulatory T cells (Tregs) in solid tumors have the potential to become interferon-gamma-producing effector T cells and that the occurrence of this reprogrammed state increases the clinical response to immune checkpoint therapy in cancer patients. Further, translational nonclinical results for MPT-0118, currently undergoing a phase 1 clinical trial (NCT04859777), are presented."

P1 data • Preclinical • Oncology • Solid Tumor

[VIRTUAL] A phase I/Ib trial study of MPT-0118 as monotherapy and in combination with pembrolizumab in subjects with advanced or metastatic solid tumors (ESMO 2021) - P1 | "The primary objectives of Parts A and B are to determine the safety and tolerability, maximum tolerated dose, dose limiting toxicities, and RP2D of MPT-0118 as monotherapy and in combination. The primary objectives of Part C are to confirm safety in combination and to evaluate the preliminary anti-tumor activity."

Clinical • Combination therapy • Monotherapy • P1 data • Hematological Malignancies • Lymphoma • Marginal Zone Lymphoma • Oncology • Solid Tumor • IFNG • MALT1 • PD-L1

Monopteros Therapeutics Initiates Clinical Trial to Reprogram Regulatory T Cells in Solid Tumors (Businesswire) - "Monopteros Therapeutics Inc...developing MPT-0118, a first-in-class MALT1 inhibitor for the treatment of solid tumors, today announced that it has dosed the first patient in its Phase 1/1b dose escalation and cohort expansion clinical trial...'Immunosuppressive regulatory T cells are preventing many patients with solid tumors from realizing the durable benefit from cancer immunotherapy currently achieved by a minority of patients,' commented Keith Flaherty, MD...In the Phase 1/1b clinical trial, MPT-0118 is provided to patients as a tablet formulation for oral dosing."

Media quote • Trial status • Oncology • Solid Tumor