Clinical Trials in Spain / NCT07127874
Recruiting
Phase 1
A Study of PHN-012 in Patients With Advanced Solid Tumors
NCT07127874 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Colon CancerPancreatic CancerLung Cancer (NSCLC)Advanced CancerAdvanced Solid Tumors
Investigational drug(s) / intervention(s)
PHN-012
PHN-012: PHN-012 is an ADC
Study summary
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.
Eligibility
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.
Primary outcome measure(s)
- Incidence of dose limiting toxicities (Phase 1a) — 12 months
- Type, incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (Phase 1a) — 12 months
- Frequency of dose interruptions, reductions, and discontinuations (Phase 1a and 1b) — 24 months
- Overall response rate (ORR) (Phase 1b) — 12 months
Trial sites (26)
| Facility | City | Region | Status |
|---|---|---|---|
| PHN-012-001 Site | Los Angeles | California | Recruiting |
| PHN-012-001 Site | San Diego | California | Recruiting |
| PHN-012-001 Site | Washington D.C. | District of Columbia | Recruiting |
| PHN-012-001 Site | Boston | Massachusetts | Recruiting |
| PHN-012-001 Site | St Louis | Missouri | Recruiting |
| PHN-012-001 Site | Durham | North Carolina | Recruiting |
| PHN-012-001 Site | Portland | Oregon | Recruiting |
| PHN-012-001 Site | Nashville | Tennessee | Recruiting |
| PHN-012-001 Site | Houston | Texas | Recruiting |
| PHN-012-001 Site | San Antonio | Texas | Recruiting |
| PHN-012-001 Site | Fairfax | Virginia | Recruiting |
| PHN-012-001 Site | Seoul | Gangnam-gu | Recruiting |
| PHN-012-001 Site | Seongnam-si | Gyeonggi-do | Recruiting |
| PHN-012-001 Site | Seoul | Jongno-gu | Recruiting |
| PHN-012-001 Site | Seoul | Seodaemun-gu | Recruiting |
| PHN-012-001 Site | Seoul | Seoucho-gu | Recruiting |
| PHN-012-001 Site | Seoul | Songpa-gu | Recruiting |
| PHN-012-001 Site | Barcelona | Community of Catalonia | Recruiting |
| PHN-012-001 Site | Barcelona | Community of Catalonia | Recruiting |
| PHN-012-001 Site | Madrid | Madrid | Recruiting |
| PHN-012-001 Site | Madrid | Madrid | Recruiting |
| PHN-012-001 Site | Madrid | Madrid | Recruiting |
| PHN-012-001 Site | Madrid | Madrid | Recruiting |
| PHN-012-001 Site | Madrid | Madrid | Recruiting |
| PHN-012-001 Site | Valencia | Valencia | Recruiting |
| PHN-012-001 Site | Valencia | Valencia | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07127874 on ClinicalTrials.gov ↗ ← All trials in Spain