CLN-418 Study on Subjects With Advanced Solid Tumors

Last updated: April 23, 2025
Sponsor: Harbour BioMed US, Inc.
Overall Status: Completed

Phase

1

Condition

Neoplasms

Treatment

CLN-418

Clinical Study ID

NCT05306444
CLN-418-001
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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., breastcancer, ovarian cancer, endometrial cancer, cervical cancer, squamous cell non-smallcell lung cancer (sNSCLC), cholangiocarcinoma, esophagus cancer, urothelialcarcinoma, head and neck squamous cell carcinoma (HNSCC)), followed bydose-expansion cohorts (Part 2) of subjects with advanced and/or metastaticnon-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC).orrecurrent and progressed since last antitumor therapy for which no alternative,curative standard therapy exists.

  4. Adequate organ and bone marrow function.

Exclusion

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 tofirst dose of investigational product, any other anti-cancer therapy within 2 weeksprior to first dose of investigational product.

  3. Not yet recovered from surgery or (immune-related) toxicity related with previoustreatment.

  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 eithersymptomatic or untreated that require concurrent treatment.

  7. Active infection that requires treatment with antibiotics or antiviral treatmentwithin 3 weeks prior to first dose of investigational product.

  8. Known history of infection with human immunodeficiency virus or known acquiredimmunodeficiency syndrome (AIDS).

  9. Known autoimmune disease.

  10. Clinically significant cardiac condition.

  11. Pregnant or breastfeeding women.

Study Design

Total Participants: 48
Treatment Group(s): 1
Primary Treatment: CLN-418
Phase: 1
Study Start date:
May 12, 2022
Estimated Completion Date:
September 10, 2024

Study 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 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.

Connect with a study center

  • St George Private Hospital

    Kogarah, New South Wales 2217
    Australia

    Site Not Available

  • Southern Medical Day Care Centre

    Wollongong, New South Wales 2500
    Australia

    Site Not Available

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California 90033
    United States

    Site Not Available

  • Florida Cancer Specialists

    Sarasota, Florida 34232
    United States

    Site Not Available

  • Carolina BioOncology Institute - Cancer Research Centre

    Huntersville, North Carolina 28078
    United States

    Site Not Available

  • MD Anderson

    Houston, Texas 77030
    United States

    Site Not Available

  • NEXT Oncology

    Irving, Texas 75039
    United States

    Site Not Available

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