ixotatug vedotin (TORL-1-23)

Collagen and silicone punctal plugs were placed and the patient was started on preservative free artificial tears, topical loteprednol 0.5 %, later replaced with topical prednisolone acetate 1 % drops, and brimonidine 0.2 % in both eyes. Ocular symptoms and exam findings waxed and waned with continued infusions of the ADC. This case reports an incidence of corneal pseudomicrocysts associated with TORL-1-23 treatment, which should be recognized as a potential adverse effect of this novel therapy.

P1, N=90, Recruiting, TORL Biotherapeutics, LLC | Trial primary completion date: Apr 2025 --> Aug 2026 | Trial completion date: Nov 2025 --> Nov 2026

P1, N=90, Recruiting, TORL Biotherapeutics, LLC | Trial primary completion date: Nov 2024 --> Apr 2025

P2, N=230, Recruiting, TORL Biotherapeutics, LLC | Not yet recruiting --> Recruiting

P2, N=230, Not yet recruiting, TORL Biotherapeutics, LLC

19 patients with platinum-resistant/refractory ovarian cancer were evaluated across 8 dose levels (0.2 to 2.4 mg/kg IV every 3 weeks, 21 day cycles) (data cutoff 01APR2023). Most pts had ≥ 3 prior treatment lines in the metastatic setting. The most common treatment-related adverse events were Gr1 peripheral neuropathy (n=3), Gr1/2 fatigue (n=2), and Gr1 nausea (n=2).

Conclusions In participants with heavily-pretreated CLDN6-expressing ovarian cancer, the novel TORL-1-23 ADC has a favorable safety/tolerability profile and encouraging antitumor activity in a phase 1 dose finding study. Further evaluation in ovarian cancer and other CLDN6+ cancers is warranted.

TORL-1-23 has a favorable safety/tolerability profile and PK characteristics with preliminary antitumor activity in pts with heavily-pretreated CLDN6-expressing ovarian and testicular cancers. Doses above the historic MTD for MMAE containing ADCs may be explored given the safety/tolerability and PK data observed up to 2.4 mg/kg. Dose finding is ongoing to identify the MTD and optimal doses for subsequent development.