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Trial Title:
A Study of PHN-010 in Patients with Advanced Solid Tumors
NCT ID:
NCT06457997
Condition:
Lung Cancer
Colon Cancer
Endometrial Cancer
Ovarian Cancer
Cervical Cancer
Advanced Solid Tumor
Advanced Cancer
Conditions: Official terms:
Endometrial Neoplasms
Conditions: Keywords:
Antibody-Drug Conjugate
Carcinoma
Cancer
Solid Tumor
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
PHN-010
Description:
PHN-010 is an ADC
Arm group label:
Phase 1a and Phase 1b
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.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
- Has histologically confirmed, advanced/metastatic:
1. Colorectal adenocarcinoma (CRC), or
2. Serous, endometroid, or clear-cell epithelial ovarian cancer, fallopian tube
cancer, or primary peritoneal cancer, or
3. Serous, endometroid or clear-cell endometrial cancer, or
4. Adenocarcinoma or squamous-cell carcinoma of the cervix, or
5. 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.
- 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).
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 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
AdventHealth
Address:
City:
Orlando
Zip:
32804
Country:
United States
Status:
Recruiting
Contact:
Last name:
Guru Sonpavde, MD
Facility:
Name:
Sarah Cannon Research Institute
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Contact:
Phone:
(844) 482-4812
Contact backup:
Last name:
Vivek Subbiah, MD
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Funda Meric-Bernstam, MD
Facility:
Name:
NEXT - San Antonio
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ildefonso Ismael Rodriguez, MD
Facility:
Name:
NEXT - Virginia
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Contact:
Last name:
M. Adham Salkeni, MD, FRCPC
Start date:
July 1, 2024
Completion date:
July 2027
Lead sponsor:
Agency:
Pheon Therapeutics
Agency class:
Industry
Source:
Pheon Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06457997
