roltotatug vedotin (TORL-4-500) / TORL Biotherap - LARVOL DELTA

TORL4500-001: A Phase 1, First in Human Study of TORL-4-500 in Patients With Advanced Cancer (clinicaltrials.gov) - P1 | N=70 | Active, not recruiting | Sponsor: TORL Biotherapeutics, LLC | Recruiting ➔ Active, not recruiting | Trial completion date: Oct 2026 ➔ May 2027 | Trial primary completion date: Oct 2025 ➔ Mar 2027

Enrollment closed • First-in-human • Trial completion date • Trial primary completion date • Hepatocellular Cancer • Oncology • Solid Tumor

Therapeutic potential of TORL-4-500, an antibody-drug conjugate directed against delta like non-canonical notch ligand 1 (DLK1) (AACR 2024) - P1 | "Each of the doses tested in this study was well tolerated in mice with no dose-limiting toxicity observed. The nonclinical pharmacokinetics and toxicokinetics of TORL-4-500 were characterized in mice and monkeys and results support dosing in humans.In summary, TORL-4-500 is a novel therapeutic for DLK1 positive cancers and on the basis of these promising preclinical efficacy results, a first in human trial to evaluate safety, tolerability, pharmacokinetics, and antitumor activity of TORL-4-500 has been launched in patients with advanced cancer and is currently ongoing (NCT06005740)."

ADC • First-in-human • Genito-urinary Cancer • Lung Cancer • Melanoma • Oncology • Sarcoma • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Testicular Cancer • DLK1

A phase I, first in human study of TORL-4-500 in patients with advanced cancer (ESMO 2024) - P1 | "This study is currently open with patients enrolling in dose escalation. Once the RP2D is established, dose expansion in DLK1+ indication-specific cohorts will commence."

Clinical • Metastases • P1 data • Genito-urinary Cancer • Lung Cancer • Oncology • Pancreatic Cancer • Sarcoma • Solid Tumor • Testicular Cancer • DLK1 • NOTCH1

TORL BioTherapeutics Announces $158 Million Oversubscribed Series B-2 Financing to Advance the Clinical Development of its Novel Antibody-Drug Conjugate (ADC) Oncology Pipeline (PRNewswire) - "Proceeds from this Series B-2 financing will be used to continue the clinical development of TORL-1-23, the Company's first-in-class ADC to treat CLDN 6+ tumors, through Phase 1 and a pivotal Phase 2 trial that will start in the second half of 2024....Proceeds will also be used to fund the on-going Phase 1 studies for the TORL-2-307 program, both a monoclonal antibody (mAb) and an ADC, for the treatment of CLDN 18.2+ solid tumors, TORL-3-600, an ADC for the treatment of CDH17+ colorectal cancer, and TORL-4-500, an ADC for the treatment of Delta like non-canonical Notch Ligand 1 (DLK1) positive solid tumors."

Financing • New P1 trial • New P2 trial • Colorectal Cancer • Gastroesophageal Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor

A Phase 1, First in Human Study of TORL-4-500 in Patients With Advanced Cancer (clinicaltrials.gov) - P1 | N=70 | Recruiting | Sponsor: TORL Biotherapeutics, LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Oncology • Solid Tumor

First in Human Study of TORL-4-500 in Participants With Advanced Cancer (clinicaltrials.gov) - P1 | N=70 | Not yet recruiting | Sponsor: TORL Biotherapeutics, LLC

Metastases • New P1 trial • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Oncology • Solid Tumor