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Clinical Trials in the USA / NCT07127874
Recruiting Phase 1

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

NCT07127874 · tracked via the Priya Life Science USA tracker
Sponsor
Pheon Therapeutics
Phase
Phase 1
Started
2025-09-23
Last updated
2026-08-06

Condition(s) studied

Colon CancerPancreatic CancerLung Cancer (NSCLC)Advanced CancerAdvanced Solid Tumors

Investigational drug(s) / intervention(s)

PHN-012

PHN-012: PHN-012 is an ADC

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (26)

FacilityCityRegionStatus
PHN-012-001 Site Los Angeles California Recruiting
PHN-012-001 Site San Diego California Recruiting
PHN-012-001 Site Washington D.C. District of Columbia Recruiting
PHN-012-001 Site Boston Massachusetts Recruiting
PHN-012-001 Site St Louis Missouri Recruiting
PHN-012-001 Site Durham North Carolina Recruiting
PHN-012-001 Site Portland Oregon Recruiting
PHN-012-001 Site Nashville Tennessee Recruiting
PHN-012-001 Site Houston Texas Recruiting
PHN-012-001 Site San Antonio Texas Recruiting
PHN-012-001 Site Fairfax Virginia Recruiting
PHN-012-001 Site Seoul Gangnam-gu Not Yet Recruiting
PHN-012-001 Site Seongnam-si Gyeonggi-do Not Yet Recruiting
PHN-012-001 Site Seoul Jongno-gu Recruiting
PHN-012-001 Site Seoul Seodaemun-gu Recruiting
PHN-012-001 Site Seoul Seoucho-gu Not Yet Recruiting
PHN-012-001 Site Seoul Songpa-gu Not Yet Recruiting
PHN-012-001 Site Barcelona Community of Catalonia Recruiting
PHN-012-001 Site Barcelona Community of Catalonia Recruiting
PHN-012-001 Site Madrid Madrid Not Yet Recruiting
PHN-012-001 Site Madrid Madrid Recruiting
PHN-012-001 Site Madrid Madrid Recruiting
PHN-012-001 Site Madrid Madrid Recruiting
PHN-012-001 Site Madrid Madrid Recruiting
PHN-012-001 Site Valencia Valencia Recruiting
PHN-012-001 Site Valencia Valencia Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07127874 on ClinicalTrials.gov ↗ ← All trials in the USA