Tagworks Pharmaceuticals BV has announced the initiation of the third dose level in its ongoing Phase 1 clinical trial for TGW101, a first-in-class antibody-drug conjugate (ADC) targeting tumor-associated glycoprotein 72 (TAG-72) in patients with advanced solid tumors. This milestone underscores the company’s commitment to advancing its innovative Click-to-Release technology, which aims to enhance therapeutic outcomes in oncology.
CEO Ken Mills expressed optimism regarding the trial’s progress, citing the favorable safety profile observed thus far as a key factor in the Safety Oversight Committee’s decision to escalate dosing. The trial is designed to evaluate safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity, with the primary objectives focused on determining the maximum tolerated dose and recommended Phase 2 dose.
Currently, the trial has successfully initiated three dose levels, with plans for up to seven, contingent upon ongoing safety assessments. As Tagworks aims to enroll up to 50 patients across U.S. sites, the implications of this trial extend beyond immediate safety data, potentially addressing significant unmet needs in solid tumor treatment. Preliminary findings are expected to be shared in early to mid-2026, marking a critical juncture for the development of TGW101 and its role in the evolving landscape of cancer therapeutics.
