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PHN-012 for people with advanced colon, lung (NSCLC), or pancreatic cancer.

First-in-Human, Phase 1 Study of PHN-012, an Antibody Drug Conjugate, in Patients With Advanced Solid Tumors

Phase 1 Interventional Pheon Therapeutics · NCT07127874

This trial will try PHN-012, a new antibody-drug conjugate, in people with advanced colon, non-small cell lung, or pancreatic cancer who have already received other treatments.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment165 (estimated)
Ages18 Years and up
SexAll
SponsorPheon Therapeutics Industry-sponsored
Drugs / interventionsradiation
Locations21 sites (Los Angeles, California and 20 other locations)
Trial IDNCT07127874 on ClinicalTrials.gov

What this trial studies

This is a first-in-human Phase 1, dose-escalation trial of PHN-012 designed to define safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity. Eligible participants must have advanced or metastatic colorectal adenocarcinoma, non-small cell lung cancer, or pancreatic ductal adenocarcinoma with measurable disease, ECOG 0-1, prior systemic therapy, and available tumor tissue. Patients who previously received ADCs with a topoisomerase‑I payload, who have unstable CNS metastases, or clinically significant unresolved toxicities are excluded. Sites for dosing and follow-up are in Los Angeles, San Diego, and Washington, D.C., and the study will collect serial blood samples and tumor assessments to characterize safety and early signals of efficacy.

Who should consider this trial

Good fit: People with advanced or metastatic colorectal adenocarcinoma, non-small cell lung cancer, or pancreatic ductal adenocarcinoma who have measurable disease, ECOG performance status 0 or 1, have progressed after at least one prior systemic therapy, and can provide tumor tissue are the intended candidates.

Not a fit: Patients with unstable brain metastases, ongoing Grade >1 toxicities from prior therapy, prior exposure to ADCs carrying a topoisomerase‑I payload, poor organ function, or ECOG >1 are unlikely to be eligible or benefit from this trial.

Why it matters

Potential benefit: If successful, PHN-012 could provide a new targeted treatment option that shrinks tumors or controls disease in patients who have exhausted standard therapies.

How similar studies have performed: Other antibody-drug conjugates that deliver topoisomerase‑I inhibitors have shown meaningful clinical activity and led to regulatory approvals in certain cancers, so this approach has precedent.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Has histologically confirmed, advanced/metastatic:

  1. Colorectal adenocarcinoma (CRC), or
  2. Non-small cell lung cancer (NSCLC), or
  3. 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).

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 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.

Where this trial is running

Los Angeles, California and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Colon CancerPancreatic CancerLung CancerAdvanced CancerAdvanced Solid TumorsAntibody Drug ConjugateCarcinomaCancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.