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

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:
ORR: 45% (n=20)

Doses of 2.4 mg/kg:
ORR: 50% (n=8); DoR: 22 weeks

Doses of 3.0 mg/kg:
ORR: 42% (n=12); DoR: 30 weeks

Clinically Significant Adverse Events

Serious AE:
Grade 3-4 AE: neutropenia (23%), fatigue (16.7%)

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
https://www.clearityfoundation.org/wp-content/uploads/2023/11/TORL-1-23-abstract-ESMO-2023.pdf

Konecny GE et al. Poster
https://www.clearityfoundation.org/wp-content/uploads/2023/11/TORL-1-23-poster-ESMO-2023.pdf

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
https://www.prnewswire.com/news-releases/torl-biotherapeutics-announces-appointment-of-mark-j-alles-as-chairman-and-chief-executive-officer-highlights-significant-progress-of-its-oncology-clinical-programs-302029058.html

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