NCT07127874RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 29 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 165 (estimated)
- First submitted
- 11 Aug 2025
- Start date
- 23 Sept 2025
- Primary completion date
- Sept 2027
- Lead sponsor
- Pheon Therapeutics
- Diseases
- Lung cancer, Pancreatic cancer, Colorectal cancer
- NCT number
- NCT07127874
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 165
- From 23 Sept 2025 to the primary completion date, Sept 2027
- 16 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Had prior treatment with any ADC containing topoisomerase-1 inhibiting payload.
- 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.
Other
- Has unstable central nervous system metastasis.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.