A Phase 1 Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of CLN-418 in Subjects With Advanced Solid Tumors

CLN-418-001

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.

2022-05-12

2024-06-01

2024-06-01

Recruiting

Early phase I

108

Inclusion Criteria: 1. Willingness to sign a written informed consent document. 2. Male or female subject aged ≥18 years old at the time of screening. 3. 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. 4. Adequate organ and bone marrow function. Exclusion Criteria: 1. Prior used anti-B7H4 and/or anti-4-1BB antibody treatment. 2. 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. 3. Not yet recovered from surgery or (immune-related) toxicity related with previous treatment. 4. Known history or active infection of hepatitis B or C. 5. History of cirrhosis or non-alcohol steatohepatitis, alcohol or drug-related, autoimmune hepatitis. 6. Known brain metastases or other central nervous system metastases that are either symptomatic or untreated that require concurrent treatment. 7. Active infection that requires treatment with antibiotics or antiviral treatment within 3 weeks prior to first dose of investigational product. 8. Known history of infection with human immunodeficiency virus or known acquired immunodeficiency syndrome (AIDS). 9. Known autoimmune disease. 10. Clinically significant cardiac condition. 11. Pregnant or breastfeeding women.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Dose escalation (Part 1) followed by Dose expansion (Part 2)', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 108, 'type': 'ESTIMATED'}}

2023-12-13