A Study of PHN-012 in Patients With Advanced Solid Tumors
Not Applicable
Not yet recruiting
- Conditions
- Colon CancerPancreatic CancerAdvanced CancerAdvanced Solid TumorsLung Cancer (NSCLC)
- Interventions
- Registration Number
- NCT07127874
- Lead Sponsor
- Pheon Therapeutics
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 165
Inclusion 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 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Phase 1a and Phase 1b PHN-012 PHN-012 is administered intravenously
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Pharmacokinetics, Cmax of free payload (Phase 1a and 1b) 24 months Type, incidence and severity of AEs and SAEs (Phase 1b) 12 months Best overall response (BOR) (Phase 1a and 1b) 24 months Pharmacokinetics, Tmax of total antibody (Phase 1a and 1b) 24 months Pharmacokinetics, Tmax of free payload (Phase 1a and 1b) 24 months Pharmacokinetics, area under the curve (AUC) of total ADC (Phase 1a and 1b) 24 months Pharmacokinetics, time of Cmax (Tmax) of total ADC (Phase 1a and 1b) 24 months Pharmacokinetics, AUC of total free payload (Phase 1a and 1b) 24 months Pharmacokinetics, terminal half-life (t1/2) of total ADC (Phase 1a and 1b) 24 months Concentration of anti-drug antibodies (Phase 1a and 1b) 24 months Disease control rate (DCR) (Phase 1a and 1b) 24 months Progression free survival (PFS) (Phase 1a and 1b) 24 months Time to response (TTR) (Phase 1a and 1b) 24 months Overall survival (OS) (Phase 1a and 1b) 24 months Pharmacokinetics, maximum concentration (Cmax) of total ADC (Phase 1a and 1b) 24 months Pharmacokinetics, Cmax of total antibody (Phase 1a and 1b) 24 months Pharmacokinetics, AUC of total antibody (Phase 1a and 1b) 24 months Pharmacokinetics, t1/2 of total antibody (Phase 1a and 1b) 24 months Pharmacokinetics, t1/2 of free payload (Phase 1a and 1b) 24 months
Trial Locations
- Locations (1)
PHN-012-001 Site
🇺🇸Fairfax, Virginia, United States
PHN-012-001 Site🇺🇸Fairfax, Virginia, United States