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

Study Identifier:
PHN-012-001
CT.gov Identifier:
NCT07127874
EudraCT Identifier:
202552000000
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Bowel (Colorectal)
  • Pancreas
  • Non-Small Cell Lung Cancer
  • Unspecified Cancer
  • Solid Tumor
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: EXPERIMENTAL: Phase 1a and Phase 1b
    • Read More
  • Drug: PHN-012 is administered intravenously
  • Drug: Drug: PHN-012
  • Drug: PHN-012 is an ADC
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (CIOCC)
    Madrid, Spain, 28050
    Investigator
    Emiliano Calvo
    Status
    Recruiting
    Condition(s) Treated at Site
    Bowel (Colorectal)
    Pancreas
    Non-Small Cell Lung Cancer
    Unspecified Cancer
    Solid Tumor
    Location
    START Barcelona
    Barcelona, Spain, 08023
    Investigator
    Tatiana Hernandez Guerrero
    Status
    Recruiting
    Condition(s) Treated at Site
    Bowel (Colorectal)
    Pancreas
    Non-Small Cell Lung Cancer
    Unspecified Cancer
    Solid Tumor
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Victor Moreno Garcia
    Status
    Recruiting
    Condition(s) Treated at Site
    Bowel (Colorectal)
    Pancreas
    Non-Small Cell Lung Cancer
    Unspecified Cancer
    Solid Tumor