Advanced Solid TumorPhase 1NCT05306444
CLN-418 Study on Subjects With Advanced Solid Tumors
A Phase 1 study testing CLN-418 in people with Advanced Solid Tumor, run by Harbour BioMed US, Inc. at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- CLN-418
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 12 May 2022to 10 Sep 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States5 sites
MD Anderson
Houston, Texas, 77030
Carolina BioOncology Institute - Cancer Research Centre
Huntersville, North Carolina, 28078
NEXT Oncology
Irving, Texas, 75039
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Florida Cancer Specialists
Sarasota, Florida, 34232
Australia2 sites
St George Private Hospital
Kogarah, New South Wales, 2217
Southern Medical Day Care Centre
Wollongong, New South Wales, 2500
About this study
Official title: 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
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.
Read the detailed 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.
- Conditions
- Advanced Solid Tumor
- Being tested
- CLN-418
- Keywords
- Advanced Solid Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLN-418Drug
Also called HBM7008
Intravenous (IV) administration
| Study group | Role | What they receive |
|---|---|---|
| CLN-418: Part 1 | Experimental | 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 Receives: Drug: CLN-418 |
| CLN-418: Part 2 | Experimental | Experimental Part 2: Dose Expansion
Treatment administered at Maximum Tolerated Dose (MTD) and / or Recommended Phase 2 Dose (RP2D) established in Part 1 Receives: Drug: CLN-418 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with dose-limiting toxicity (DLT)
Number of subjects who experienced DLT events during 21 days after first administration of CLN-418, divided by the number of DLT evaluable Subjects
Measured: From Day 1 until day 21
Secondary outcomes (9)
Adverse events (AEs) according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Number of participants with Adverse Events (including vital signs, physical examinations, and abnormal laboratory parameters).
Measured: From signing of Informed Consent Form (ICF) till 84 days after last dose
Objective response rate, defined as the proportion of subjects with best overall response of complete response (CR) or partial response (PR) per RECIST 1.1
Proportion of subjects with best overall response of complete response (CR) or partial response (PR) per RECIST 1.1
Measured: From time of consent until the first documented disease progression, unacceptable toxicity, withdrawal of consent, lack of treatment benefits, death or study termination whichever comes first, assessed up to 12 months
Duration of response
The time interval from first occurrence of a documented objective response to the time of disease progression as determined by the Investigator using RECIST 1.1 or death from any cause, whichever comes first.
Measured: From time of consent until the first documented disease progression, unacceptable toxicity, withdrawal of consent, lack of treatment benefits, death or study termination whichever comes first, assessed up to 12 months
Disease control rate
The proportion of subjects with a best overall response of Complete Response (CR), Partial Response (PR), or stable disease (SD).
Measured: From time of consent until the first documented disease progression, unacceptable toxicity, withdrawal of consent, lack of treatment benefits, death or study termination whichever comes first, assessed up to 12 months.
Duration of disease control
The time from the date of start of treatment to the date of disease progression or death for subjects who had CR or PR or SD during treatment
Measured: From time of consent until the first documented disease progression, unacceptable toxicity, withdrawal of consent, lack of treatment benefits, death or study termination whichever comes first, assessed up to 12 months.
Maximal tumor shrinkage
The greatest tumor shrinkage achieved at any follow-up assessment
Measured: From time of consent until the first documented disease progression, unacceptable toxicity, withdrawal of consent, lack of treatment benefits, death or study termination whichever comes first, assessed up to 12 months
Pharmacokinetics Analysis - Serum Concentration
Reporting of serum concentration of CLN-418
Measured: Up to 84 days post last dose
Anti-drug antibodies
Measure of detectable Anti-drug antibody (ADA) and neutralizing antibodies in serum samples at specific study timepoints
Measured: Up to 84 days post last dose
Pharmacokinetics Analysis - Time Deviation
Reporting time deviation data of CLN-418
Measured: Up to 84 days post last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start12 May 2022
- Primary completion28 Aug 2024
- Study completion10 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Dose escalation (Part 1) followed by Dose expansion (Part 2)
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harbour BioMed US, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05306444
- Sponsor's protocol ID
- CLN-418-001
- Status last verified
- Apr 2025
- First submitted
- 24 Feb 2022
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data generated by this study will be considered confidential by the Investigator, except to the extent that it is included in a publication. The general strategy regarding publication of the study will be mutually agreed upon by the Investigator and Sponsor. The Sponsor reserves the right to manage the publication of all study results. The Investigator agrees that oral and written communication to third parties of any procedures or results from the study is subject to prior written consent of the Sponsor. Presentation material and/or manuscript(s) for publication will be reviewed by the Sponsor prior to submission for publication. Alterations in the material will only be made in agreement between the Investigator and the Sponsor
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05306444
- Acronym / sponsor ID
- CLN-418-001
- Conditions
- Advanced Solid Tumor
- Keywords
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Harbour BioMed US, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 May 2022 (actual)
- Primary completion
- 28 Aug 2024 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 1 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Dose escalation (Part 1) followed by Dose expansion (Part 2)
| Arm | Type | Receives |
|---|---|---|
| CLN-418: Part 1 | Experimental | Drug: CLN-418Experimental 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: Part 2 | Experimental | Drug: CLN-418Experimental Part 2: Dose Expansion Treatment administered at Maximum Tolerated Dose (MTD) and / or Recommended Phase 2 Dose (RP2D) established in Part 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CLN-418Also: HBM7008Intravenous (IV) administration | Drug | CLN-418: Part 1, CLN-418: Part 2 |
Primary outcome
Proportion of subjects with dose-limiting toxicity (DLT)
Time frame: From Day 1 until day 21
Number of subjects who experienced DLT events during 21 days after first administration of CLN-418, divided by the number of DLT evaluable Subjects
9 secondary outcomes
Adverse events (AEs) according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Time frame: From signing of Informed Consent Form (ICF) till 84 days after last dose
Objective response rate, defined as the proportion of subjects with best overall response of complete response (CR) or partial response (PR) per RECIST 1.1
Time frame: From time of consent until the first documented disease progression, unacceptable toxicity, withdrawal of consent, lack of treatment benefits, death or study termination whichever comes first, assessed up to 12 months
Duration of response
Time frame: From time of consent until the first documented disease progression, unacceptable toxicity, withdrawal of consent, lack of treatment benefits, death or study termination whichever comes first, assessed up to 12 months
Disease control rate
Time frame: From time of consent until the first documented disease progression, unacceptable toxicity, withdrawal of consent, lack of treatment benefits, death or study termination whichever comes first, assessed up to 12 months.
Duration of disease control
Time frame: From time of consent until the first documented disease progression, unacceptable toxicity, withdrawal of consent, lack of treatment benefits, death or study termination whichever comes first, assessed up to 12 months.
Maximal tumor shrinkage
Time frame: From time of consent until the first documented disease progression, unacceptable toxicity, withdrawal of consent, lack of treatment benefits, death or study termination whichever comes first, assessed up to 12 months
Pharmacokinetics Analysis - Serum Concentration
Time frame: Up to 84 days post last dose
Anti-drug antibodies
Time frame: Up to 84 days post last dose
Pharmacokinetics Analysis - Time Deviation
Time frame: Up to 84 days post last dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Individual participant dataSharing planned: No. Data generated by this study will be considered confidential by the Investigator, except to the extent that it is included in a publication. The general strategy regarding publication of the study will be mutually agreed upon by the Investigator and Sponsor. The Sponsor reserves the right to manage the publication of all study results. The Investigator agrees that oral and written communication to third parties of any procedures or results from the study is subject to prior written consent of the Sponsor. Presentation material and/or manuscript(s) for publication will be reviewed by the Sponsor prior to submission for publication. Alterations in the material will only be made in agreement between the Investigator and the Sponsor
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CLN-418 in people with Advanced Solid Tumor, run by Harbour BioMed US, Inc. at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with dose-limiting toxicity (DLT) (time frame: From Day 1 until day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.