A Study of PHN-012 in Patients With Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorPheon Therapeutics
About this trial
This first-in-human study will evaluate safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of PHN-012, a novel antibody-drug conjugate (ADC), in patients with advanced solid tumors.
Eligibility criteria
Qualifiers
Colorectal adenocarcinoma (CRC), or
Non-small cell lung cancer (NSCLC), or
Pancreatic ductal adenocarcinoma (PDAC).
Has received at least one prior systemic therapy and radiologically or clinically determined progressive disease during or after the most recent line of therapy, and for whom no further standard therapy is available or who is intolerant to standard therapy.
Disqualifiers
Had prior treatment with any ADC containing topoisomerase-1 inhibiting payload.
Has unstable central nervous system metastasis.
Has persistent toxicities from previous systemic anti-cancer treatments of Grade >1.
Has received systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of the study drug.
Trial design
Treatments tested in this trial
- PHN-012
Treatment groups
165 Participants
are divided into 1 treatment groupLocations
20Spain
PHN-012-001 Site08023, BarcelonaCommunity of Catalonia, Spain
PHN-012-001 Site08035, BarcelonaCommunity of Catalonia, Spain
PHN-012-001 Site28007, MadridMadrid, Spain
PHN-012-001 Site28027, MadridMadrid, Spain
Sponsors and collaborators
Pheon Therapeutics
Lead sponsor
Source ClinicalTrials.gov