A Study of PHN-010 in Patients With Advanced Solid Tumors

Stopped early · Phase 1

Conditions studied: Lung Cancer, Colon Cancer, Endometrial Cancer, Ovarian Cancer, Cervical Cancer, Advanced Solid Tumor, Advanced Cancer

In brief

This first-in-human study will evaluate safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of PHN-010, a novel antibody-drug conjugate (ADC), in patients with advanced solid tumors.

Key facts

Study ID

NCT06457997

Run by

Pheon Therapeutics

People needed

26

Starts

2024-07-01

Expected to finish

2025-09-11

Last updated by the study team

2026-01-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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 acute and/or clinically significant bacterial, fungal, or viral infection including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV).
• Has a history of non-infectious pneumonitis (NIP) / interstitial lung disease (ILD) requiring systemic steroids, active NIP / ILD or suspected NIP / ILD which cannot be ruled out by imaging for Screening.
• Other protocol defined Inclusion/Exclusion criteria apply.

Where it is running

• AdventHealth — Orlando, Florida, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• NEXT - San Antonio — San Antonio, Texas, United States
• NEXT - Virginia — Fairfax, Virginia, United States
• University of Washington/Fred Hutchinson Cancer Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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