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 |