Clinical trial · Interventional
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
NCT07127874CI-TRIAL-00120915recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260930-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer (NSCLC) | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PHN-012 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Phase 1a and Phase 1b
- description
- PHN-012 is administered intravenously
- interventionNames
- Drug: PHN-012
Primary outcomes (4)
- measure
- Incidence of dose limiting toxicities (Phase 1a)
- timeFrame
- 12 months
- measure
- Type, incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (Phase 1a)
- timeFrame
- 12 months
- measure
- Frequency of dose interruptions, reductions, and discontinuations (Phase 1a and 1b)
- timeFrame
- 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.