TGW211 / Tagworks - LARVOL DELTA

CleavHER: TGW211 for Click-Cleavable Imaging in HER2-Positive Cancers. (clinicaltrials.gov) - P1 | N=19 | Recruiting | Sponsor: Radboud University Medical Center

Trial initiation date • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Preclinical evaluation of click-cleavable radioimmunoconjugates for enhanced treatment efficacy in radioimmunotherapy (AACR 2026) - "Tagworks' TGW211 program in Phase 0/1 aims at increasing the therapeutic index of radiolabeled trastuzumab (TGW211-DC), targeting HER2+ tumors. Moreover, beneficial dosimetry of click-cleavable TRT was projected for TGW211. A First-in-human Phase 0/1 study with HER2+ cancer patients has recently been initiated."

First-in-human • Preclinical • Oncology • HER-2

CleavHER: TGW211 for Click-Cleavable Imaging in HER2-Positive Cancers. (clinicaltrials.gov) - P1 | N=19 | Recruiting | Sponsor: Radboud University Medical Center | Initiation date: Aug 2025 ➔ Dec 2025 | Not yet recruiting ➔ Recruiting

Enrollment open • Trial initiation date • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Preclinical evaluation of a novel click-cleavable radioimmunoconjugate for improved therapy of HER2 expressing tumours (EANM 2025) - "Tagworks’ TGW211 program aims at solving this issue for HER2+ tumours using the cleavable trastuzumab radioimmunoconjugate TGW211-DC [1] . Extensive toxicological evaluation of TGW211-DC and trigger, alone or in combination, did not reveal any significant adverse effects , demonstrating safety. First-in-human study with HER2-positive cancer patients is in preparation."

Preclinical • Oncology • HER-2

Tagworks Pharmaceuticals Announces CTA Authorization and Initiation of Phase 0/1 Clinical Trial for TGW211, a Radiopharmaceutical for the Treatment of HER2+ Tumors (PRNewswire) - "Under an investigator-initiated trial agreement, Tagworks and Radboudumc have initiated the first-in-human Phase 0/1 clinical development of TGW211 in a single center, open-label imaging study in patients with HER2-positive solid tumors....Phase 0/1 clinical trial (CleavHER trial) of TGW211 initiated, sponsored by the Radboud University Medical Center in the Netherlands; enrollment of first patients expected by end of 2025 and preliminary safety and dosimetry data expected in 2026."

Clinical data • Trial status • Gastric Cancer • Gastroesophageal Cancer • HER2 Positive Breast Cancer

CleavHER: TGW211 for Click-Cleavable Imaging in HER2-Positive Cancers. (clinicaltrials.gov) - P1 | N=19 | Not yet recruiting | Sponsor: Radboud University Medical Center | Trial completion date: Dec 2027 ➔ Dec 2026 | Trial primary completion date: Aug 2027 ➔ Dec 2026

Trial completion date • Trial primary completion date • HER2 Positive Breast Cancer • Oncology • Solid Tumor

CleavHER: TGW211 for Click-Cleavable Imaging in HER2-Positive Cancers. (clinicaltrials.gov) - P1 | N=27 | Not yet recruiting | Sponsor: Radboud University Medical Center

New P1 trial • HER2 Positive Breast Cancer • Oncology • Solid Tumor