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NCT07127874From ClinicalTrials.govRecruiting

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

First-in-Human, Phase 1 Study of PHN-012, an Antibody Drug Conjugate, in Patients With Advanced Solid Tumors

  • Colon Cancer
  • Pancreatic Cancer
  • Lung Cancer (NSCLC)
  • Advanced Cancer
  • Advanced Solid Tumors

At a glance

Phase
Phase 1
Study type
Interventional
Sponsor
Pheon Therapeutics
Enrolment target
165
Started
23 September 2025
Main results due
September 2027
Study sites
26
Registry updated
29 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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-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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(26)

  • 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

  • PHN-012-001 Site

    Portland, Oregon, United States

    Recruiting

  • PHN-012-001 Site

    Nashville, Tennessee, United States

    Recruiting

  • PHN-012-001 Site

    Houston, Texas, United States

    Recruiting

  • PHN-012-001 Site

    San Antonio, Texas, United States

    Recruiting

  • PHN-012-001 Site

    Fairfax, Virginia, United States

    Recruiting

  • PHN-012-001 Site

    Seoul, Gangnam-gu, South Korea

    Recruiting

  • PHN-012-001 Site

    Seongnam-si, Gyeonggi-do, South Korea

    Recruiting

  • PHN-012-001 Site

    Seoul, Jongno-gu, South Korea

    Recruiting

  • PHN-012-001 Site

    Seoul, Seodaemun-gu, South Korea

    Recruiting

  • PHN-012-001 Site

    Seoul, Seoucho-gu, South Korea

    Recruiting

  • PHN-012-001 Site

    Seoul, Songpa-gu, South Korea

    Recruiting

  • PHN-012-001 Site

    Barcelona, Community of Catalonia, Spain

    Recruiting

  • PHN-012-001 Site

    Barcelona, Community of Catalonia, Spain

    Recruiting

  • PHN-012-001 Site

    Madrid, Madrid, Spain

    Recruiting

  • PHN-012-001 Site

    Madrid, Madrid, Spain

    Recruiting

  • PHN-012-001 Site

    Madrid, Madrid, Spain

    Recruiting

  • PHN-012-001 Site

    Madrid, Madrid, Spain

    Recruiting

  • PHN-012-001 Site

    Madrid, Madrid, Spain

    Recruiting

  • PHN-012-001 Site

    Valencia, Valencia, Spain

    Recruiting

  • PHN-012-001 Site

    Valencia, Valencia, Spain

    Recruiting

Showing 26 of 26 sites. 26 of the 26 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07127874. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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