A Phase 1, First in Human, Dose-Escalation Study of TORL-1-23 in Participants With Advanced Cancer

Trial ID # NCT05103683
Phase I
Drug Class Antibody Drug Conjugates: CLDN6
Drug Name TORL-1-23
Drugs in Trial TORL-1-23
Eligible Participant

Advanced solid tumors

Patients Enrolled

42 patients in dose escalation, median 4 prior therapies (1-9), 30 OC

Therapy Setting


Study Design

Open-Label, Non-randomized


ORR, evaluated per RECIST


ORR: 33.3% (9PR, n=27)

Doses of 2.4 mg/kg or 3.0 mg/kg:
ORR: 58% (7PR, n=12)

Clinically Significant Adverse Events

TORL-1-23 has a favorable safety/tolerability profile with encouraging preliminary anti-tumor activity in heavily-pretreated CLDN6-expressing ovarian cancer


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

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