Back to Trials
NCT07127874PHASE1Recruiting

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

Pheon Therapeutics

Start Date

9/23/2025

Completion Date

5/1/2028

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

Age Range: 18 years to No maximum

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.

Interventions

DRUG

PHN-012

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Colon CancerPancreatic CancerLung Cancer (NSCLC)Advanced CancerAdvanced Solid Tumors

Locations

PHN-012-001 Site

Los Angeles, California 90033

United States

PHN-012-001 Site

San Diego, California 92037

United States

PHN-012-001 Site

Washington D.C., District of Columbia 20007

United States

PHN-012-001 Site

Boston, Massachusetts 02114

United States

PHN-012-001 Site

St Louis, Missouri 63108

United States

PHN-012-001 Site

Durham, North Carolina 27710

United States

PHN-012-001 Site

Portland, Oregon 97239

United States

PHN-012-001 Site

Nashville, Tennessee 37203

United States

PHN-012-001 Site

Houston, Texas 77030

United States

PHN-012-001 Site

San Antonio, Texas 78229

United States

PHN-012-001 Site

Fairfax, Virginia 22031

United States

PHN-012-001 Site

Barcelona, Community of Catalonia 08023

Spain

PHN-012-001 Site

Barcelona, Community of Catalonia 08035

Spain

PHN-012-001 Site

Madrid, Madrid 28007

Spain

PHN-012-001 Site

Madrid, Madrid 28027

Spain

PHN-012-001 Site

Madrid, Madrid 28034

Spain

PHN-012-001 Site

Madrid, Madrid 28040

Spain

PHN-012-001 Site

Madrid, Madrid 28050

Spain

PHN-012-001 Site

Valencia, Valencia 46009

Spain

PHN-012-001 Site

Valencia, Valencia 46010

Spain