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New treatment option for Colon Cancer
Official title A Study of PHN-012 in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT07127874
What this study is testing
What is PHN-012?
PHN-012 is an investigational medicine, being studied as a potential treatment for colon cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
You likely can't join 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...
- 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...
See the full eligibility criteria
- 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...
- 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).
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- San Diego, California, United States
- Washington D.C., District of Columbia, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- Durham, North Carolina, United States
- Portland, Oregon, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Fairfax, Virginia, United States
- Barcelona, Community of Catalonia, Spain
- Madrid, Madrid, Spain
- Valencia, Valencia, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; San Diego, California, United States; Washington D.C., District of Columbia, United States; Boston, Massachusetts, United States; St Louis, Missouri, United States; Durham, North Carolina, United States and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.