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

First-in-Human, Phase 1b Study of PHN-010, an Antibody Drug Conjugate, in Patients With Advanced Solid Tumors

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.

Study Overview

• Status: Terminated
• Conditions: Cervical Cancer; Ovarian Cancer; Lung Cancer; Advanced Solid Tumor; Endometrial Cancer; Advanced Cancer; Colon Cancer
• Intervention / Treatment: Drug: PHN-010

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32804
      • Adventhealth
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Research Institute
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center
    • San Antonio, Texas, United States, 78229
      • NEXT - San Antonio
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • NEXT - Virginia
  • Washington
    • Seattle, Washington, United States, 98109
      • University of Washington/Fred Hutchinson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Has histologically confirmed, advanced/metastatic:

  1. Colorectal adenocarcinoma (CRC), or
  2. Serous, endometroid, or clear-cell epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, or
  3. Serous, endometroid or clear-cell endometrial cancer, or
  4. Adenocarcinoma or squamous-cell carcinoma of the cervix, or
  5. Non-small cell lung cancer (NSCLC).
• 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 collected ≤ 3 years prior to the date of informed consent 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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 1a and Phase 1b; PHN-010 is administered intravenously.	Drug: PHN-010; PHN-010 is an ADC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of dose limiting toxicities (Phase 1a)	18 months
Type, incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (Phase 1a)	18 months
Frequency of dose interruptions, reductions, and discontinuations (Phase 1a and 1b)	18 months
Overall response rate (ORR) (Phase 1b)	36 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Best overall response (BOR) (Phase 1a and 1b)	36 months
Disease control rate (DCR) (Phase 1a and 1b)	36 months
Progression free survival (PFS) (Phase 1a and 1b)	36 months
Time to response (TTR) (Phase 1a and 1b)	36 months
Overall survival (OS) (Phase 1a and 1b)	36 months
Cancer antigen 125 (CA-125) response (Phase 1a and 1b)	36 months
Time to CA-125 response (Phase 1a and 1b)	36 months
Pharmacokinetics, maximum concentration (Cmax) of total ADC (Phase 1a and 1b)	36 months
Pharmacokinetics, Cmax of total antibody (Phase 1a and 1b)	36 months
Pharmacokinetics, Cmax of free payload (Phase 1a and 1b)	36 months
Pharmacokinetics, time of Cmax (Tmax) of total ADC (Phase 1a and 1b)	36 months
Pharmacokinetics, Tmax of total antibody (Phase 1a and 1b)	36 months
Pharmacokinetics, Tmax of free payload (Phase 1a and 1b)	36 months
Pharmacokinetics, area under the curve (AUC) of total ADC (Phase 1a and 1b)	36 months
Pharmacokinetics, AUC of total antibody (Phase 1a and 1b)	36 months
Pharmacokinetics, AUC of total free payload (Phase 1a and 1b)	36 months
Pharmacokinetics, terminal half-life (t1/2) of total ADC (Phase 1a and 1b)	36 months
Pharmacokinetics, t1/2 of total antibody (Phase 1a and 1b)	36 months
Pharmacokinetics, t1/2 of free payload (Phase 1a and 1b)	36 months
Concentration of anti-drug antibodies (Phase 1a and 1b)	36 months
Type, incidence and severity of AEs and SAEs (Phase 1b)	18 months

Collaborators and Investigators

• Sponsor: Pheon Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): September 11, 2025
• Study Completion (Actual): September 11, 2025

Study Registration Dates

• First Submitted: June 6, 2024
• First Submitted That Met QC Criteria: June 11, 2024
• First Posted (Actual): June 13, 2024

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Cancer; Carcinoma; Solid Tumor; Antibody-Drug Conjugate
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Intestinal Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Uterine Diseases; Genital Diseases, Female; Lung Diseases; Endocrine Gland Neoplasms; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Colonic Diseases; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Uterine Cervical Diseases; Uterine Neoplasms; Neoplasms; Carcinoma; Lung Neoplasms; Colonic Neoplasms; Ovarian Neoplasms; Uterine Cervical Neoplasms; Endometrial Neoplasms
• Other Study ID Numbers: PHN-010-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No