Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2022-05-12
2024-09-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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CLN-418: Part 1
Experimental Part 1: Dose escalation
Intravenous IV administrations of CLN-418 on Day 1 of each 21 day treatment cycle
Dose for cohorts to be confirmed following consultation and approval by Safety Review Committee
CLN-418
Intravenous (IV) administration
CLN-418: Part 2
Experimental Part 2: Dose Expansion
Treatment administered at Maximum Tolerated Dose (MTD) and / or Recommended Phase 2 Dose (RP2D) established in Part 1
CLN-418
Intravenous (IV) administration
Interventions
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CLN-418
Intravenous (IV) administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Harbour BioMed US, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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CLN-418-001
Identifier Type: -
Identifier Source: org_study_id
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