| Trial ID # | NCT05103683 |
| Phase | I |
| Drug Class | Antibody Drug Conjugates: CLDN6 |
| Drug Name | TORL-1-23 |
| Drugs in Trial | TORL-1-23 |
| Eligible Participant | Platinum resistant or refractory ovarian cancer |
| Patients Enrolled | 36 patients in dose escalation, median 4 prior therapies (1-9);14 patients in dose expansion, median 3 prior therapies (1-4) |
| Therapy Setting | Recurrence |
| Study Design | Open-Label, Non-randomized |
| Endpoints | ORR, DoR, evaluated per RECIST |
| Efficacy | Doses of 2.4 mg/kg or 3.0 mg/kg: Doses of 2.4 mg/kg: Doses of 3.0 mg/kg: |
| Clinically Significant Adverse Events | Serious AE: |
| Conclusion | TORL-1-23 has a favorable safety/tolerability profile with encouraging preliminary anti-tumor activity in heavily-pretreated CLDN6-expressing ovarian cancer |
| Reference | Konecny GE et al. First-in-human phase I study of a novel claudin 6 (CLDN6) targeted antibody drug conjugate (ADC) TORL-1-23. Ann Oncol (2023) 34(2) abstract 756P Konecny GE et al. Poster TORL BioTherapeutics Announces Appointment of Mark J. Alles as Chairman and Chief Executive Officer; Highlights Significant Progress of its Oncology Clinical Programs, press release, 1/9/24 Konecny GE et al. Phase I, two-part, multicenter first-in-human (FIH) study of TORL-1-23: A novel claudin 6 (CLDN6) targeting antibody drug conjugate (ADC) in patient with advanced solid tumors. Ann Oncol (2024) 35(2) abstract 721MO |