MDX2001 / OPKO Health - LARVOL DELTA

MDX-2001-101 study protocol: a phase I/IIa, multicenter, first-in-human, open-label clinical trial evaluating MDX2001 monotherapy in patients with advanced solid tumors. (PubMed, Future Oncol) - "Here, we present the protocol design for study MDX-2001-101, a multicenter, open-label, phase I/IIa clinical trial designed to evaluate the safety, tolerability, and antitumor effects of MDX2001 in patients with advanced solid tumors. The study comprises a phase Ia dose escalation guided by a Bayesian optimal interval design with a targeted maximum tolerated dose toxicity rate of 30%, a phase Ib dose expansion, and a phase IIa indication expansion."

First-in-human • Journal • Monotherapy • P1/2 data • Oncology • Solid Tumor • MET

A phase I/IIa, multicenter, first-in-human, open-label clinical trial evaluating MDX2001, a tetraspecific T cell engager-expander in patients with advanced solid tumors (ESMO 2025) - P1/2 | "The study will be conducted in United States, Europe, and Asia. Recruitment is ongoing."

Clinical • First-in-human • Metastases • P1/2 data • Oncology • Solid Tumor • MET • TACSTD2

OPKO Health Reports Second Quarter 2025 Business Highlights and Financial Results (GlobeNewswire) - "Highlights from the second quarter of 2025 and recent weeks include the following:...The MDX2001 CMet-Trop2/CD3-CD28 tetraspecific antibody has advanced to the fifth dose level in its Phase 1 clinical trial, with Phase 1b studies in selected solid tumors expected in 2026. MDX2004, a multispecific immune rejuvenator, is expected to enter the clinic later this year. Human clinical trials with the MDX2003 tetraspecific antibody for lymphoma/leukemia are expected to begin in early 2026."

New trial • Trial status • Leukemia • Lymphoma • Solid Tumor

A phase 1/2a, multicenter, first-in-human, open-label clinical trial evaluating MDX2001, a tetraspecific T cell engager-expander in patients with advanced solid tumors. (ASCO 2025) - P1/2 | "The study will be conducted in United States, Europe, and Asia. Recruitment is ongoing."

Clinical • Metastases • P1/2 data • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Solid Tumor • MET • TACSTD2

Preclinical characterization of MDX2001, a novel tetraspecific T cell engager (CD3/CD28) targeting TROP2 and c-MET in solid tumor malignancies (SITC 2024) - "Ethics Approval Animal study conducted at Charles River Laboratories (CRL) in compliance with CRL IACUC under IACUC No. I033."

Preclinical • Breast Cancer • Hematological Malignancies • Oncology • Solid Tumor • CD28 • IFNG • IL6 • MET • TACSTD2

A quantitative systems pharmacology model for first-in-human dosing of MDX2001, a multispecific antibody for the treatment of advanced solid tumors (SITC 2024) - "Conclusions The final QSP model supports initiation of first-in-human studies with MDX2001 in patients with advanced solid tumor malignancies. Ethics Approval All animal experiments were performed under protocols approved by the appropriate Institutional Animal Care and Use Committees."

Metastases • P1 data • Oncology • Solid Tumor

A phase I/IIa first-in-human clinical trial evaluating MDX2001, a multi-specific antibody in patients with advanced solid tumor malignancies (ESMO 2024) - P1/2 | "Patients will have radiographic tumor assessments every 8 weeks and will continue to receive treatment until disease progression per RECIST v1.1 (as assessed by the investigator), unacceptable toxicity, withdrawal of consent or the sponsor terminates the study, whichever occurs first. The study will be conducted in United States,United Kingdom, Europe, and Asia."

Clinical • Metastases • P1/2 data • Oncology • Solid Tumor • MET • TACSTD2

OPKO Health Reports Second Quarter 2024 Business Highlights and Financial Results (GlobeNewswire) - "Enrollment underway in the MDX2001 Phase 1 trial for the treatment of solid tumor cancers....This Phase 1 open-label trial is expected to enroll 45 cancer patients with a variety of solid tumors at six clinical trial sites, and to evaluate safety, tolerability, pharmacokinetics and early evidence of anti-tumor activity."

Enrollment status • Solid Tumor

Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=115 | Recruiting | Sponsor: ModeX Therapeutics, An OPKO Health Company | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Monotherapy • Biliary Cancer • Breast Cancer • Cervical Cancer • Colon Cancer • Colorectal Cancer • Endocrine Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Kidney Cancer • Liver Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Prostate Cancer • Rectal Cancer • Renal Cell Carcinoma • Solid Tumor • Thyroid Gland Carcinoma

Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=115 | Not yet recruiting | Sponsor: ModeX Therapeutics, An OPKO Health Company

New P1/2 trial • Biliary Cancer • Breast Cancer • Cervical Cancer • Colon Cancer • Colorectal Cancer • Endocrine Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Kidney Cancer • Liver Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Prostate Cancer • Rectal Cancer • Renal Cell Carcinoma • Solid Tumor • Thyroid Gland Carcinoma