CLN-418 Study on Subjects With Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Advanced Solid Tumor

In brief

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.

Key facts

Study ID

NCT05306444

Run by

Harbour BioMed US, Inc.

People needed

48

Starts

2022-05-12

Expected to finish

2024-09-10

Last updated by the study team

2025-04-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• USC Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Florida Cancer Specialists — Sarasota, Florida, United States
• Carolina BioOncology Institute - Cancer Research Centre — Huntersville, North Carolina, United States
• MD Anderson — Houston, Texas, United States
• NEXT Oncology — Irving, Texas, United States
• St George Private Hospital — Kogarah, New South Wales, Australia
• Southern Medical Day Care Centre — Wollongong, New South Wales, Australia

Full record on ClinicalTrials.gov

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