A Study of PHN-010 in Patients with Advanced Solid Tumors
- Conditions
- Lung CancerColon CancerEndometrial CancerOvarian CancerCervical CancerAdvanced CancerAdvanced Solid Tumor
- Interventions
- Registration Number
- NCT06457997
- Lead Sponsor
- Pheon Therapeutics
- Brief Summary
This first-in-human study will evaluate safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of PHN-010, a novel antibody-drug conjugate (ADC), in patients with advanced solid tumors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 273
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Has histologically confirmed, advanced/metastatic:
- Colorectal adenocarcinoma (CRC), or
- Serous, endometroid, or clear-cell epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, or
- Serous, endometroid or clear-cell endometrial cancer, or
- Adenocarcinoma or squamous-cell carcinoma of the cervix, or
- Non-small cell lung cancer (NSCLC).
-
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.
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Has adequate organ function.
-
Has available tumor tissue sample at screening (either an archival specimen collected ≤ 3 years prior to the date of informed consent 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 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 acute and/or clinically significant bacterial, fungal, or viral infection including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV).
- Has a history of non-infectious pneumonitis (NIP) / interstitial lung disease (ILD) requiring systemic steroids, active NIP / ILD or suspected NIP / ILD which cannot be ruled out by imaging for Screening.
Other protocol defined Inclusion/Exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Phase 1a and Phase 1b PHN-010 PHN-010 is administered intravenously.
- Primary Outcome Measures
Name Time Method Incidence of dose limiting toxicities (Phase 1a) 18 months Type, incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (Phase 1a) 18 months Frequency of dose interruptions, reductions, and discontinuations (Phase 1a and 1b) 18 months Overall response rate (ORR) (Phase 1b) 36 months
- Secondary Outcome Measures
Name Time Method Time to response (TTR) (Phase 1a and 1b) 36 months Overall survival (OS) (Phase 1a and 1b) 36 months Cancer antigen 125 (CA-125) response (Phase 1a and 1b) 36 months Time to CA-125 response (Phase 1a and 1b) 36 months Pharmacokinetics, Cmax of free payload (Phase 1a and 1b) 36 months Pharmacokinetics, maximum concentration (Cmax) of total ADC (Phase 1a and 1b) 36 months Pharmacokinetics, Cmax of total antibody (Phase 1a and 1b) 36 months Progression free survival (PFS) (Phase 1a and 1b) 36 months Disease control rate (DCR) (Phase 1a and 1b) 36 months Pharmacokinetics, time of Cmax (Tmax) of total ADC (Phase 1a and 1b) 36 months Pharmacokinetics, Tmax of total antibody (Phase 1a and 1b) 36 months Pharmacokinetics, Tmax of free payload (Phase 1a and 1b) 36 months Pharmacokinetics, area under the curve (AUC) of total ADC (Phase 1a and 1b) 36 months Pharmacokinetics, terminal half-life (t1/2) of total ADC (Phase 1a and 1b) 36 months Best overall response (BOR) (Phase 1a and 1b) 36 months Pharmacokinetics, AUC of total antibody (Phase 1a and 1b) 36 months Pharmacokinetics, t1/2 of total antibody (Phase 1a and 1b) 36 months Pharmacokinetics, t1/2 of free payload (Phase 1a and 1b) 36 months Pharmacokinetics, AUC of total free payload (Phase 1a and 1b) 36 months Concentration of anti-drug antibodies (Phase 1a and 1b) 36 months Type, incidence and severity of AEs and SAEs (Phase 1b) 18 months
Trial Locations
- Locations (8)
AdventHealth
🇺🇸Orlando, Florida, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
NEXT - San Antonio
🇺🇸San Antonio, Texas, United States
NEXT - Virginia
🇺🇸Fairfax, Virginia, United States
University of Washington/Fred Hutchinson Cancer Center
🇺🇸Seattle, Washington, United States