Status:
COMPLETED
CLN-418 Study on Subjects With Advanced Solid Tumors
Lead Sponsor:
Harbour BioMed US, Inc.
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Study to evaluate the safety and tolerability of the study drug CLN-418, to determine the maximum tolerated dose and/or recommended Phase 2 study dose of CLN-418.
Detailed Description
This is a study to evaluate the safety and tolerability of the study drug CLN-418, and to determine the maximum tolerated dose and/or recommended Phase 2 study dose of CLN-418. The study will also lo...
Eligibility Criteria
Inclusion
- Willingness to sign a written informed consent document.
- Male or female subject aged ≥18 years old at the time of screening.
- Histologically or cytologically confirmed advanced solid tumors (e.g., breast cancer, ovarian cancer, endometrial cancer, cervical cancer, squamous cell non-small cell lung cancer (sNSCLC), cholangiocarcinoma, esophagus cancer, urothelial carcinoma, head and neck squamous cell carcinoma (HNSCC)), followed by dose-expansion cohorts (Part 2) of subjects with advanced and/or metastatic non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC).or recurrent and progressed since last antitumor therapy for which no alternative, curative standard therapy exists.
- Adequate organ and bone marrow function.
Exclusion
- Prior used anti-B7H4 and/or anti-4-1BB antibody treatment.
- Immuno-oncology therapy or targeted anti-cancer therapy within 4 weeks prior to first dose of investigational product, any other anti-cancer therapy within 2 weeks prior to first dose of investigational product.
- Not yet recovered from surgery or (immune-related) toxicity related with previous treatment.
- Known history or active infection of hepatitis B or C.
- History of cirrhosis or non-alcohol steatohepatitis, alcohol or drug-related, autoimmune hepatitis.
- Known brain metastases or other central nervous system metastases that are either symptomatic or untreated that require concurrent treatment.
- Active infection that requires treatment with antibiotics or antiviral treatment within 3 weeks prior to first dose of investigational product.
- Known history of infection with human immunodeficiency virus or known acquired immunodeficiency syndrome (AIDS).
- Known autoimmune disease.
- Clinically significant cardiac condition.
- Pregnant or breastfeeding women.
Key Trial Info
Start Date :
May 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 10 2024
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT05306444
Start Date
May 12 2022
End Date
September 10 2024
Last Update
April 25 2025
Active Locations (7)
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1
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
2
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
3
Carolina BioOncology Institute - Cancer Research Centre
Huntersville, North Carolina, United States, 28078
4
MD Anderson
Houston, Texas, United States, 77030