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

Last updated: April 16, 2026
Sponsor: Pheon Therapeutics
Overall Status: Active - Recruiting

Phase

1

Condition

Pancreatitis

Digestive System Neoplasms

Pancreatic Cancer

Treatment

PHN-012

Clinical Study ID

NCT07127874
PHN-012-001
  • Ages > 18
  • All Genders

Study 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

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 clinicallydetermined progressive disease during or after the most recent line of therapy, andfor whom no further standard therapy is available or who is intolerant to standardtherapy.

  • 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 freshbiopsy material).

Exclusion

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 fracturewithin 14 days prior to first dose of the study drug, or no recovery from sideeffects of such intervention.

  • Had major surgery (not including placement of vascular access device or tumorbiopsies) within 28 days prior to first dose of the study drug, or no recovery fromside 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 forScreening.

Study Design

Total Participants: 165
Treatment Group(s): 1
Primary Treatment: PHN-012
Phase: 1
Study Start date:
September 23, 2025
Estimated Completion Date:
May 31, 2028

Connect with a study center

  • PHN-012-001 Site

    Barcelona, Community of Catalonia 08035
    Spain

    Site Not Available

  • PHN-012-001 Site

    Madrid, Madrid 28050
    Spain

    Active - Recruiting

  • PHN-012-001 Site

    Valencia, Valencia 46010
    Spain

    Active - Recruiting

  • PHN-012-001 Site

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • PHN-012-001 Site

    San Diego, California 92037
    United States

    Site Not Available

  • PHN-012-001 Site

    Washington D.C., District of Columbia 20007
    United States

    Active - Recruiting

  • PHN-012-001 Site

    Washington D.C. 4140963, District of Columbia 4138106 20007
    United States

    Site Not Available

  • PHN-012-001 Site

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • PHN-012-001 Site

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Site Not Available

  • PHN-012-001 Site

    St Louis, Missouri 63108
    United States

    Active - Recruiting

  • PHN-012-001 Site

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • PHN-012-001 Site

    Durham 4464368, North Carolina 4482348 27710
    United States

    Site Not Available

  • PHN-012-001 Site

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • PHN-012-001 Site

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • PHN-012-001 Site

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Site Not Available

  • PHN-012-001 Site

    Houston, Texas 77030
    United States

    Active - Recruiting

  • PHN-012-001 Site

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • PHN-012-001 Site

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • PHN-012-001 Site

    San Antonio 4726206, Texas 4736286 78229
    United States

    Site Not Available

  • PHN-012-001 Site

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • PHN-012-001 Site

    Fairfax 4758023, Virginia 6254928 22031
    United States

    Site Not Available

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