NCT07127874 A Study of PHN-012 in Patients With Advanced Solid Tumors
| NCT ID | NCT07127874 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Pheon Therapeutics |
| Condition | Colon Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 165 participants |
| Start Date | 2025-09-23 |
| Primary Completion | 2027-09 |
Trial Parameters
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Brief Summary
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
Inclusion Criteria: * Has histologically confirmed, advanced/metastatic: 1. Colorectal adenocarcinoma (CRC), or 2. Non-small cell lung cancer (NSCLC), or 3. 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. * Has measurable disease. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Has adequate organ function. * Has available tumor tissue sample at screening (either an archival specimen or fresh biopsy material). Exclusion Criteria: * 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-l
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