ProfoundBio, a US-based clinical-stage biotechnology company developing novel antibody-drug conjugate (ADC) therapeutics for cancer, announced on Monday that it has commenced dosing in the Phase 1/2 first-in-human clinical trial of PRO1107 (NCT06171789).

The product is being assessed in a global, open-label, multicentre Phase 1/2 trial that is designed to determine the safety, tolerability, pharmacokinetics, and antitumor activity of PRO1107 in subjects with advanced solid tumours, which includes non-small cell lung, breast, and ovarian cancer. It is designed as a two part study, Part A is intended to determine the recommended optimal dose regimen(s) via dose escalation and expansion, and Part B concentrates on the expansion of treatment to specific tumour types.

Naomi Hunder, MD, ProfoundBio chief medical officer, said, 'By bringing the first ADC with our next generation MMAE linker-drug platform to the clinic, we are furthering our commitment to developing ADCs with the potential for improved outcomes for patients. We believe our preclinical data support the potential of PRO1107 to provide much improved safety and activity compared to prior PTK7 ADCs, demonstrating the compelling attributes of our LD343 platform, which incorporates our novel highly hydrophilic linker combined with the clinically validated MMAE payload conjugated at a high drug-antibody ratio of 8. We look forward to evaluating PRO1107 as a treatment for the broad population of patients with PTK7-expressing tumours, and we are thankful to the investigators and patients who make this research possible.'