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Recruiting NCT07127874

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

Phase I Interventional Colon Cancer Pancreatic Cancer Lung Cancer (NSCLC) Advanced Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PHN-012.
Who it may be relevant to
Registry conditions: Colon Cancer, Pancreatic Cancer, Lung Cancer (NSCLC), Advanced Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, South Korea, Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug PHN-012
    PHN-012 is an ADC

Primary outcome measures

  • Incidence of dose limiting toxicities (Phase 1a) [Time frame: 12 months]
  • Type, incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (Phase 1a) [Time frame: 12 months]
  • Frequency of dose interruptions, reductions, and discontinuations (Phase 1a and 1b) [Time frame: 24 months]
  • Overall response rate (ORR) (Phase 1b) [Time frame: 12 months]
Secondary outcome measures (12)
  • Best overall response (BOR) (Phase 1a and 1b) [Time frame: 24 months]
  • Disease control rate (DCR) (Phase 1a and 1b) [Time frame: 24 months]
  • Progression free survival (PFS) (Phase 1a and 1b) [Time frame: 24 months]
  • Time to response (TTR) (Phase 1a and 1b) [Time frame: 24 months]
  • Overall survival (OS) (Phase 1a and 1b) [Time frame: 24 months]
  • Pharmacokinetics, maximum concentration (Cmax) of total ADC (Phase 1a and 1b) [Time frame: 24 months]
  • Pharmacokinetics, Cmax of total antibody (Phase 1a and 1b) [Time frame: 24 months]
  • Pharmacokinetics, Cmax of free payload (Phase 1a and 1b) [Time frame: 24 months]
  • Pharmacokinetics, time of Cmax (Tmax) of total ADC (Phase 1a and 1b) [Time frame: 24 months]
  • Pharmacokinetics, Tmax of total antibody (Phase 1a and 1b) [Time frame: 24 months]
  • Pharmacokinetics, Tmax of free payload (Phase 1a and 1b) [Time frame: 24 months]
  • Pharmacokinetics, area under the curve (AUC) of total ADC (Phase 1a and 1b) [Time frame: 24 months]

Eligibility criteria

Inclusion criteria

  • 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).

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 11 centers
  • PHN-012-001 Site — Los Angeles
  • PHN-012-001 Site — San Diego
  • PHN-012-001 Site — Washington D.C.
  • PHN-012-001 Site — Boston
  • PHN-012-001 Site — St Louis
  • PHN-012-001 Site — Durham
  • PHN-012-001 Site — Portland
  • PHN-012-001 Site — Nashville
  • … and 3 more centers
Spain · 9 centers
  • PHN-012-001 Site — Barcelona
  • PHN-012-001 Site — Barcelona
  • PHN-012-001 Site — Madrid
  • PHN-012-001 Site — Madrid
  • PHN-012-001 Site — Madrid
  • PHN-012-001 Site — Madrid
  • PHN-012-001 Site — Madrid
  • PHN-012-001 Site — Valencia
  • … and 1 more center
South Korea · 6 centers
  • PHN-012-001 Site — Seoul
  • PHN-012-001 Site — Seongnam-si
  • PHN-012-001 Site — Seoul
  • PHN-012-001 Site — Seoul
  • PHN-012-001 Site — Seoul
  • PHN-012-001 Site — Seoul

Identifiers

NCT: NCT07127874 · PHN-012-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗