CLN-418 Study on Subjects With Advanced Solid Tumors

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 look at the anti-tumor activity, pharmacokinetics and immunogenicity of CLN-418.The study consists of 2 parts. In Part 1, patients are enrolled into different cohort doses in order to identify the appropriate recommended phase 2 dose (RP2D) or maximum tolerated dose (MTD). In Part 2, participants with metastatic / unresectable Non small cell lung cancer (NSCLC), Triple Negative Breast Cancer (TNBC) will receive the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) established in Part 1 of the study. In Part 1 and Part 2, participants will be administered treatment every 3 weeks.

Inclusion criteria

• 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 criteria

• 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.