PHN-012 for people with advanced colon, lung (NSCLC), or pancreatic cancer.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human Phase 1, dose-escalation trial of PHN-012 designed to define safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity. Eligible participants must have advanced or metastatic colorectal adenocarcinoma, non-small cell lung cancer, or pancreatic ductal adenocarcinoma with measurable disease, ECOG 0-1, prior systemic therapy, and available tumor tissue. Patients who previously received ADCs with a topoisomerase‑I payload, who have unstable CNS metastases, or clinically significant unresolved toxicities are excluded. Sites for dosing and follow-up are in Los Angeles, San Diego, and Washington, D.C., and the study will collect serial blood samples and tumor assessments to characterize safety and early signals of efficacy.

Why it matters

Who can join: the full rules

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-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's running

• PHN-012-001 Site
  Los Angeles, California, United States Recruiting
• PHN-012-001 Site
  San Diego, California, United States Recruiting
• PHN-012-001 Site
  Washington D.C., District of Columbia, United States Recruiting
• PHN-012-001 Site
  Boston, Massachusetts, United States Recruiting
• PHN-012-001 Site
  St Louis, Missouri, United States Recruiting
• PHN-012-001 Site
  Durham, North Carolina, United States Recruiting

Study contacts

• Study coordinator: Myles Clancy
• Email: PHN012001trial@pheontx.com
• Phone: 1-857-342-3090

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.