Actively Recruiting
First-in-Human Study of PHN-012 Antibody Drug Conjugate in Patients With Advanced Solid Tumors
Led by Pheon Therapeutics · Updated on 2026-06-05
165
Participants Needed
20
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating PHN-012, a new antibody-drug conjugate (ADC), in patients with advanced solid tumors including colorectal adenocarcinoma, non-small cell lung cancer, and pancreatic ductal adenocarcinoma. This first-in-human phase 1 study aims to assess the safety, tolerability, anti-tumor activity, immune response, pharmacokinetics, and pharmacodynamics of PHN-012 in patients who have progressed after prior systemic therapy and have no further standard options. PHN-012 is given intravenously during the study. Participants receive treatment in phase 1a and phase 1b periods, where researchers monitor dose limiting toxicities, adverse events, dose adjustments, and overall response rates. The study includes assessments over 12 to 24 months to understand the drug's behavior, effectiveness, and safety profile in this patient group. Participants will be closely monitored with regular evaluations including measurement of tumor response, disease control, survival, and immune system reactions. Researchers will collect blood samples to study drug levels and immune responses over time. Safety is closely followed by tracking adverse events and serious adverse events. The study will last up to 24 months with ongoing assessments to gather comprehensive data on PHN-012's effects and tolerability.
CONDITIONS
Brief Title
A Study of PHN-012 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has histologically confirmed advanced or metastatic colorectal adenocarcinoma, non-small cell lung cancer, or pancreatic ductal adenocarcinoma.
- Has received at least one prior systemic therapy with progressive disease during or after the most recent therapy.
- Has no further standard therapy available or is intolerant to standard therapy.
- Has measurable disease.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Has adequate organ function.
- Has available tumor tissue sample at screening (archival or fresh biopsy).
You will not qualify if you...
- Prior treatment with any antibody-drug conjugate containing topoisomerase-1 inhibiting payload.
- Unstable central nervous system metastasis.
- Persistent toxicities from previous systemic anti-cancer treatments of Grade greater than 1.
- Received systemic anti-neoplastic therapy within five half-lives or 21 days before first dose.
- Received wide-field radiotherapy (> 30% marrow-bearing bones) within 28 days or focal radiation for pain or fracture risk within 14 days before first dose without recovery.
- Had major surgery (excluding vascular access placement or biopsies) within 28 days before first dose without recovery.
- History of non-infectious pneumonitis or interstitial lung disease requiring steroids within 6 months or active/suspected condition not ruled out by imaging at screening.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months depending on individual response and tolerance
Participants receive PHN-012 administered intravenously as part of the study treatment for their advanced solid tumors.
Regular visits for treatment administration and monitoring
Trial Site Locations
Total: 20 locations
1
PHN-012-001 Site
Los Angeles, California, United States, 90033
Actively Recruiting
2
PHN-012-001 Site
San Diego, California, United States, 92037
Not Yet Recruiting
3
PHN-012-001 Site
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
4
PHN-012-001 Site
Boston, Massachusetts, United States, 02114
Actively Recruiting
5
PHN-012-001 Site
St Louis, Missouri, United States, 63108
Actively Recruiting
6
PHN-012-001 Site
Durham, North Carolina, United States, 27710
Actively Recruiting
7
PHN-012-001 Site
Portland, Oregon, United States, 97239
Actively Recruiting
8
PHN-012-001 Site
Nashville, Tennessee, United States, 37203
Actively Recruiting
9
PHN-012-001 Site
Houston, Texas, United States, 77030
Actively Recruiting
10
PHN-012-001 Site
San Antonio, Texas, United States, 78229
Actively Recruiting
11
PHN-012-001 Site
Fairfax, Virginia, United States, 22031
Actively Recruiting
12
PHN-012-001 Site
Barcelona, Community of Catalonia, Spain, 08023
Actively Recruiting
13
PHN-012-001 Site
Barcelona, Community of Catalonia, Spain, 08035
Actively Recruiting
14
PHN-012-001 Site
Madrid, Madrid, Spain, 28007
Not Yet Recruiting
15
PHN-012-001 Site
Madrid, Madrid, Spain, 28027
Actively Recruiting
16
PHN-012-001 Site
Madrid, Madrid, Spain, 28034
Actively Recruiting
17
PHN-012-001 Site
Madrid, Madrid, Spain, 28040
Actively Recruiting
18
PHN-012-001 Site
Madrid, Madrid, Spain, 28050
Actively Recruiting
19
PHN-012-001 Site
Valencia, Valencia, Spain, 46009
Actively Recruiting
20
PHN-012-001 Site
Valencia, Valencia, Spain, 46010
Actively Recruiting
Research Team
M
Myles Clancy
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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