First-in-Human, Phase 1 Study of PHN-012, an Antibody Drug Conjugate, in Patients With Advanced Solid Tumors
Study Identifier:
PM14-A-003-20
CT.gov Identifier:
EudraCT Identifier:
EU Trial (CTIS) Number:
N/A
Study Contact Information:
Recruiting
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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.
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Bowel (Colorectal)
Pancreas
Non-Small Cell Lung Cancer
Unspecified Cancer
Solid Tumor
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
Female & Male
Age
18+ years
Study Drug
Drug: EXPERIMENTAL: Phase 1a and Phase 1b
Read More
Drug: PHN-012 is administered intravenously
Drug: Drug: PHN-012
Drug: PHN-012 is an ADC
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting
Requirements information
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.
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START Madrid, Spain (CIOCC)
Madrid, Spain, 28050
Investigator
Juan José Soto
Status
Recruitment Complete
Condition(s) Treated at Site
Bowel (Colorectal)
Pancreas
Non-Small Cell Lung Cancer
Unspecified Cancer
Solid Tumor