A Study of PHN-012 in Patients With Advanced Solid Tumors

Recruiting now · Phase 1

Conditions studied: Colon Cancer, Pancreatic Cancer, Lung Cancer (NSCLC), Advanced Cancer, Advanced Solid Tumors

In brief

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.

Key facts

Study ID

NCT07127874

Run by

Pheon Therapeutics

People needed

165

Starts

2025-09-23

Expected to finish

2028-05-01

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has histologically confirmed, advanced/metastatic:
• 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.
• 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).

You may not qualify if…

• 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.
• Has received wide-field radiotherapy (> 30% of marrow-bearing bones) within 28 days, or focal radiation for analgesic purpose or for lytic lesions at risk of fracture within 14 days prior to first dose of the study drug, or no recovery from side effects of such intervention.
• Had major surgery (not including placement of vascular access device or tumor biopsies) within 28 days prior to first dose of the study drug, or no recovery from side effects of such intervention.
• Has a history of non-infectious pneumonitis (NIP) / interstitial lung disease (ILD) requiring systemic steroids within 6 months prior to first dose of the study drug, active NIP / ILD or suspected NIP / ILD which cannot be ruled out by imaging for Screening.

Where it is running

• PHN-012-001 Site — Valencia, Valencia, Spain (enrolling)
• PHN-012-001 Site — San Diego, California, United States (enrolling)
• PHN-012-001 Site — Washington D.C., District of Columbia, United States (enrolling)
• PHN-012-001 Site — Boston, Massachusetts, United States (enrolling)
• PHN-012-001 Site — St Louis, Missouri, United States (enrolling)
• PHN-012-001 Site — Durham, North Carolina, United States (enrolling)
• PHN-012-001 Site — Portland, Oregon, United States (enrolling)
• PHN-012-001 Site — Nashville, Tennessee, United States (enrolling)
• PHN-012-001 Site — Houston, Texas, United States (enrolling)
• PHN-012-001 Site — San Antonio, Texas, United States (enrolling)
• PHN-012-001 Site — Fairfax, Virginia, United States (enrolling)
• PHN-012-001 Site — Madrid, Madrid, Spain (enrolling)
• PHN-012-001 Site — Madrid, Madrid, Spain (enrolling)
• PHN-012-001 Site — Madrid, Madrid, Spain (enrolling)
• PHN-012-001 Site — Valencia, Valencia, Spain (enrolling)
• PHN-012-001 Site — Los Angeles, California, United States (enrolling)
• PHN-012-001 Site — Seoul, Jongno-gu, South Korea (enrolling)
• PHN-012-001 Site — Seoul, Seodaemun-gu, South Korea (enrolling)
• PHN-012-001 Site — Barcelona, Community of Catalonia, Spain (enrolling)
• PHN-012-001 Site — Barcelona, Community of Catalonia, Spain (enrolling)
• PHN-012-001 Site — Madrid, Madrid, Spain (enrolling)
• PHN-012-001 Site — Seoul, Gangnam-gu, South Korea
• PHN-012-001 Site — Seongnam-si, Gyeonggi-do, South Korea
• PHN-012-001 Site — Seoul, Songpa-gu, South Korea
• PHN-012-001 Site — Madrid, Madrid, Spain

Full record on ClinicalTrials.gov

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