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

NCT06457997 | Terminated Phase 1 FDA Drug

• 1 other identifier: PHN-010-001
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Lung Cancer; Colon Cancer; Endometrial Cancer; Ovarian Cancer; Cervical Cancer; Advanced Solid Tumor; Advanced Cancer

Keywords

Antibody-Drug Conjugate; Carcinoma; Cancer; Solid Tumor

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (21)

• 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

Study Arms (1)

Phase 1a and Phase 1b

EXPERIMENTAL

PHN-010 is administered intravenously.

Drug: PHN-010

Interventions

PHN-010 DRUG

PHN-010 is an ADC

Phase 1a and Phase 1b

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has histologically confirmed, advanced/metastatic:
• Colorectal adenocarcinoma (CRC), or
• Serous, endometroid, or clear-cell epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, or
• Serous, endometroid or clear-cell endometrial cancer, or
• Adenocarcinoma or squamous-cell carcinoma of the cervix, or
• 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).

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.

Sponsors & Collaborators

• Pheon Therapeutics: lead

Study Sites (8)

AdventHealth

Orlando, Florida, 32804, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

NEXT - San Antonio

San Antonio, Texas, 78229, United States

Location

NEXT - Virginia

Fairfax, Virginia, 22031, United States

Location

University of Washington/Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Colonic Neoplasms; Endometrial Neoplasms; Ovarian Neoplasms; Uterine Cervical Neoplasms; Carcinoma; Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Cervical Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 13, 2024
• Study Start: July 1, 2024
• Primary Completion: September 11, 2025
• Study Completion: September 11, 2025
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)