A Study of PHN-012 in Patients With Advanced Solid Tumors
First-in-Human, Phase 1 Study of PHN-012, an Antibody Drug Conjugate, in Patients With Advanced Solid Tumors
1 other identifier
interventional
165
2 countries
21
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2025
Typical duration for phase_1
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2025
CompletedFirst Posted
Study publicly available on registry
August 17, 2025
CompletedStudy Start
First participant enrolled
September 23, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2028
April 17, 2026
April 1, 2026
1.9 years
August 11, 2025
April 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Incidence of dose limiting toxicities (Phase 1a)
12 months
Type, incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (Phase 1a)
12 months
Frequency of dose interruptions, reductions, and discontinuations (Phase 1a and 1b)
24 months
Overall response rate (ORR) (Phase 1b)
12 months
Secondary Outcomes (19)
Best overall response (BOR) (Phase 1a and 1b)
24 months
Disease control rate (DCR) (Phase 1a and 1b)
24 months
Progression free survival (PFS) (Phase 1a and 1b)
24 months
Time to response (TTR) (Phase 1a and 1b)
24 months
Overall survival (OS) (Phase 1a and 1b)
24 months
- +14 more secondary outcomes
Study Arms (1)
Phase 1a and Phase 1b
EXPERIMENTALPHN-012 is administered intravenously
Interventions
Eligibility Criteria
You may qualify if:
- Has histologically confirmed, advanced/metastatic:
- Colorectal adenocarcinoma (CRC), or
- Non-small cell lung cancer (NSCLC), or
- 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).
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 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
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, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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
August 11, 2025
First Posted
August 17, 2025
Study Start
September 23, 2025
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
May 1, 2028
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share