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RecruitingPhase 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests PHN-012 in humans for the first time. PHN-012 is an antibody linked to a cancer-killing drug, and the study checks its safety, how it works in the body, and its effects on tumors. It is for people with certain advanced colon, rectal, lung, or pancreatic cancers.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • A tissue test shows advanced or spread cancer: colorectal adenocarcinoma, non-small cell lung cancer, or pancreatic ductal adenocarcinoma.
  • Had at least one cancer treatment that works throughout the body. Cancer grew during or after the latest treatment, and no more standard treatment is available or its side effects cannot be tolerated.
  • Have cancer that can be measured.
  • Are fully active or can do light work, with limits only on hard physical activity.
  • Have organs that work well enough for the study.
  • Have a tumor tissue sample available at screening, from an earlier test or a new biopsy.

Who can't join

  • Previously had an antibody-linked cancer drug carrying a topoisomerase-1 blocker, a drug that blocks an enzyme cancer cells use.
  • Have cancer that has spread to the brain or spinal cord and is not stable.
  • Still have side effects worse than mild from earlier cancer treatments that work throughout the body.
  • Had cancer treatment that works throughout the body too close to the first study dose: within 21 days or the time for the drug amount to halve five times, whichever is shorter.
  • Had radiation to more than 30% of bones containing bone marrow within 28 days before the first dose; targeted radiation for pain or weakened bones at risk of breaking within 14 days; or have not recovered from radiation side effects.
  • Had major surgery within 28 days before the first dose, or have not recovered from its side effects. Surgery to place a device for blood vessel access or take a tumor sample does not count.
  • Have lung inflammation or scarring not caused by infection that is active or cannot be ruled out by screening scans, or needed steroid treatment throughout the body for it within 6 months before the first dose.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (11)

CA

DC

MA

MO

NC

OR

TN

TX

VA