Advanced Solid Tumor MalignancyPhase 1NCT05501821
Study of KBA1412 in Participants With Advanced Solid Malignant Tumors
A Phase 1 study testing KBA1412 and Pembrolizumab in people with Advanced Solid Tumor Malignancy, run by Kling Biotherapeutics B.V. at 5 sites in 2 countries.
Trial summary
The purpose of this trial is to assess the safety and efficacy of KBA1412, a patient derived, fully human, monoclonal antibody targeting CD9, in patients with advanced solid malignant tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor Malignancy
- What is being tested?
- KBA1412 and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 8 Aug 2022to 24 Jul 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
- Male or female patients aged ≥18 years.
- Histologically and/or cytologically confirmed locally advanced or metastatic solid tumors refractory to standard therapy or for whom no standard therapy is available.
- For Parts B and C, patients for whom anti-PD-1 or anti-programmed cell death ligand 1 (anti-PD-L1) are the SOC should have progressed on these therapies before being eligible for enrollment in Parts B and C. Patients cannot have received more than one anti-PD-1 or anti-PD-L1 based regimen.
- Disease accessible for core needle biopsy both pre- and post-treatment with KBA1412. Biopsies will be mandatory for patients with melanoma and required for other tumor types depending on feasibility of obtaining tissue.
- Measurable disease defined as: At least 1 lesion of ≥10 mm in the longest diameter for a non lymph node or ≥15 mm in the short-axis diameter for a lymph node that is serially measurable according to iRECIST using CT/MRI and will not be used for on-study paired biopsies.
- ECOG Performance Status of 0-1.
- Adequate hematologic, renal and hepatic function
Who cannot join
- History of severe hypersensitivity reactions to other monoclonal antibodies.
- Prior treatment with:
- Any chemotherapy, anticancer small molecule therapy or investigational drug or device within 14 days or 5 half-lives (whichever is longer) prior to study treatment administration
- Biological agents (including monoclonal antibodies) within 28 days prior to study treatment administration
- Radiation, within 14 days prior to study treatment administration
- Treatment with nitrosoureas or mitomycin C require a 42-day washout prior to study treatment administration
Show all 18Show fewer
- Anti-CD40 antibody or with FMS-like tyrosine kinase 3 ligand (FLT3L)
- KBA1412.
- Major surgery or significant traumatic injury within 4 weeks prior to study treatment administration.
- Excluding the primary tumor leading to enrollment in this study, any other active malignancy (except for definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the bladder or cervix) within 24 months prior to study treatment administration.
- Untreated primary central nervous system (CNS) malignancy.
- Use of immunosuppressive medications within 4 weeks or systemic corticosteroids at doses exceeding 10 mg/ day (prednisone equivalent) within 2 weeks prior to study treatment administration.
- Active autoimmune disease that has required systemic treatment within 2 years prior to study treatment administration.
- Clinically significant cardiovascular disease, e.g., cerebral vascular accident/stroke or myocardial infarction, within 6 months prior to study treatment administration, unstable angina, congestive heart failure (New York Heart Association [NYHA] Class ≥III), or unstable cardiac arrhythmia requiring medication.
- History of a major bleeding event (requiring a blood transfusion of >2 units) not related to a tumor within 12 months prior to study treatment administration.
- Ongoing Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 toxicity related to a previously administered anticancer agent with the following exceptions:
- CTCAE Grade 2 neuropathy or alopecia
- CTCAE Grade 2 immune-related endocrinopathy attributed to a checkpoint inhibitor and controlled with hormone replacement alone.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Netherlands3 sites
Dutch Cancer Institute AVL
Amsterdam, 1066 CX
University Hospital Leiden (LUMC)
Leiden, 2333 ZA
Erasmus Medical Center Rotterdam
Rotterdam, 3015 GD
Belgium2 sites
University Hospital Antwerp
Antwerp, 2650
University Hospital Ghent
Ghent, 9000
About this study
Official title: A Phase I, First-in-human, Multicenter, Open-label, Dose Escalation Followed by an Expansion Phase Clinical Study of KBA1412 Given as Monotherapy or in Combination With Pembrolizumab in Adults With Advanced Solid Malignant Tumors
The purpose of this trial is to assess the safety and efficacy of KBA1412, a patient derived, fully human, monoclonal antibody targeting CD9, in patients with advanced solid malignant tumors
Read the detailed description
Patient interested in participation in a clinical study will be informed about the study and potential risks, all patients giving written informed consent will undergo a 3-week screening period to determine their eligibility for entry in the study. Patients will receive KBA1412 or KBA1412 in combination with pembrolizumab.
- Conditions
- Advanced Solid Tumor Malignancy
- Being tested
- KBA1412, Pembrolizumab
- Keywords
- solid tumor adult, refractory cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KBA1412Drug
Part A, B, C
PembrolizumabDrug
Also called Keytruda
Part C only
| Study group | Role | What they receive |
|---|---|---|
| Part A, dose escalation monotherapy | Experimental | KBA1412 monotherapy, given intravenously, Q3W, multiple dose levels Receives: Drug: KBA1412 |
| Part B, expansion monotherapy | Experimental | KBA1412 monotherapy, given intravenously, Q3W, at fixed dose as defined in dose-escalation phase (Part A) Receives: Drug: KBA1412 |
| Part C, expansion combination therapy | Experimental | KBA1412 in combination with pembrolizumab, given intravenously, Q3W, KBA1412 at fixed dose as defined in dose-escalation phase (Part A), Pembrolizumab at fixed dose Receives: Drug: KBA1412; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A & B & C: Frequency and severity of AEs as assessed by CTCAE v5.0
Monitoring incidence and severity of Adverse Events during trial participation for each participant
Measured: Through study completion, an average of 1 year
Part A: Frequency and type of DLT s using the CTCAE v5.0
A DLT is defined as an adverse event that is unrelated to disease progression, intercurrent illness, or concomitant medications and is occurring during the first 21 days of treatment. These events will be classified according to the CTCAE v5.0
Measured: First 21 days of treatment
Number of participants with an antitumor response to KBA1412 monotherapy (Part B) or to KBA1412 in combination with pembrolizumab (Part C)
Response according to immune Response Evaluation Criteria in Solid Tumors (iRECIST)
Measured: Approximately 24 weeks
Secondary outcomes (4)
Part A: Number of participants with an antitumor response to KBA1412 monotherapy
Response according to immune Response Evaluation Criteria in Solid Tumors (iRECIST)
Measured: Approximately 24 weeks
Pharmacokinetic of KBA1412 monotherapy (Part A & B) and KBA1412 in combination with pembrolizumab (Part C), area under the concentration versus time curve (AUC)
Area under the plasma concentration versus time curve (AUC) of KBA1412 will be assessed in all participants
Measured: Approximately 24 weeks
Incidence and prevalence of anti-KBA1412 antibodies for KBA1412 monotherapy (Part A & B) and KBA1412 in combination with pembrolizumab (Part C)
Development of antibodies (anti-drug antibodies) to KBA1412 will be evaluated for all participants
Measured: Approximately 24 weeks
Change in biomarkers for KBA1412 monotherapy (Part A & B) and KBA1412 in combination with pembrolizumab (Part C) pre- and post-dose in tumor tissue
Change in pharmacodynamic properties of KBA1412 pre- and post-dose in immune infiltration, activation and cytotoxicity assessed by Immunohistochemistry
Measured: Approximately 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start8 Aug 2022
- Primary completion24 Jul 2024
- Study completion24 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid Tumor MalignancyStudies 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
- Part A will consist of multiple cohorts, each at an escalated dose level of KBA1412. Part B will consist of disease specific cohorts, each cohort treated with KBA1412 at a fixed dose level. Part C will consist of disease specific cohorts, each cohort treated with KBA1412 at a fixed dose in combination with pembrolizumab at a fixed dose.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kling Biotherapeutics B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05501821
- Sponsor's protocol ID
- KBA1412-101
- Status last verified
- Sep 2025
- First submitted
- 4 Aug 2022
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, First-in-human, Multicenter, Open-label, Dose Escalation Followed by an Expansion Phase Clinical Study of KBA1412 Given as Monotherapy or in Combination With Pembrolizumab in Adults With Advanced Solid Malignant Tumors
- ClinicalTrials.gov ID
- NCT05501821
- Acronym / sponsor ID
- KBA1412-101
- Conditions
- Advanced Solid Tumor Malignancy
- Keywords
- solid tumor adult, refractory cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Kling Biotherapeutics B.V.Industry (pharma, biotech, devices)
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 24 Jul 2024 (actual)
- Study completion
- 24 Jul 2024 (actual)
- First posted
- 15 Aug 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.
The purpose of this trial is to assess the safety and efficacy of KBA1412, a patient derived, fully human, monoclonal antibody targeting CD9, in patients with advanced solid malignant tumors
Detailed description
Patient interested in participation in a clinical study will be informed about the study and potential risks, all patients giving written informed consent will undergo a 3-week screening period to determine their eligibility for entry in the study. Patients will receive KBA1412 or KBA1412 in combination with pembrolizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Part A will consist of multiple cohorts, each at an escalated dose level of KBA1412. Part B will consist of disease specific cohorts, each cohort treated with KBA1412 at a fixed dose level. Part C will consist of disease specific cohorts, each cohort treated with KBA1412 at a fixed dose in combination with pembrolizumab at a fixed dose.
| Arm | Type | Receives |
|---|---|---|
| Part A, dose escalation monotherapy | Experimental | Drug: KBA1412KBA1412 monotherapy, given intravenously, Q3W, multiple dose levels |
| Part B, expansion monotherapy | Experimental | Drug: KBA1412KBA1412 monotherapy, given intravenously, Q3W, at fixed dose as defined in dose-escalation phase (Part A) |
| Part C, expansion combination therapy | Experimental | Drug: KBA1412, Drug: PembrolizumabKBA1412 in combination with pembrolizumab, given intravenously, Q3W, KBA1412 at fixed dose as defined in dose-escalation phase (Part A), Pembrolizumab at fixed dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patients aged ≥18 years.
- Histologically and/or cytologically confirmed locally advanced or metastatic solid tumors refractory to standard therapy or for whom no standard therapy is available.
- For Parts B and C, patients for whom anti-PD-1 or anti-programmed cell death ligand 1 (anti-PD-L1) are the SOC should have progressed on these therapies before being eligible for enrollment in Parts B and C. Patients cannot have received more than one anti-PD-1 or anti-PD-L1 based regimen.
- Disease accessible for core needle biopsy both pre- and post-treatment with KBA1412. Biopsies will be mandatory for patients with melanoma and required for other tumor types depending on feasibility of obtaining tissue.
- Measurable disease defined as: At least 1 lesion of ≥10 mm in the longest diameter for a non lymph node or ≥15 mm in the short-axis diameter for a lymph node that is serially measurable according to iRECIST using CT/MRI and will not be used for on-study paired biopsies.
Key exclusion criteria (18 listed)
- History of severe hypersensitivity reactions to other monoclonal antibodies.
- Prior treatment with:
- Major surgery or significant traumatic injury within 4 weeks prior to study treatment administration.
- Excluding the primary tumor leading to enrollment in this study, any other active malignancy (except for definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the bladder or cervix) within 24 months prior to study treatment administration.
- Untreated primary central nervous system (CNS) malignancy.
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 |
|---|---|---|
| KBA1412Part A, B, C | Drug | Part A, dose escalation monotherapy, Part B, expansion monotherapy, Part C, expansion combination therapy |
| PembrolizumabAlso: KeytrudaPart C only | Drug | Part C, expansion combination therapy |
Primary outcome
Part A & B & C: Frequency and severity of AEs as assessed by CTCAE v5.0
Time frame: Through study completion, an average of 1 year
Monitoring incidence and severity of Adverse Events during trial participation for each participant
Part A: Frequency and type of DLT s using the CTCAE v5.0
Time frame: First 21 days of treatment
A DLT is defined as an adverse event that is unrelated to disease progression, intercurrent illness, or concomitant medications and is occurring during the first 21 days of treatment. These events will be classified according to the CTCAE v5.0
Number of participants with an antitumor response to KBA1412 monotherapy (Part B) or to KBA1412 in combination with pembrolizumab (Part C)
Time frame: Approximately 24 weeks
Response according to immune Response Evaluation Criteria in Solid Tumors (iRECIST)
4 secondary outcomes
Part A: Number of participants with an antitumor response to KBA1412 monotherapy
Time frame: Approximately 24 weeks
Pharmacokinetic of KBA1412 monotherapy (Part A & B) and KBA1412 in combination with pembrolizumab (Part C), area under the concentration versus time curve (AUC)
Time frame: Approximately 24 weeks
Incidence and prevalence of anti-KBA1412 antibodies for KBA1412 monotherapy (Part A & B) and KBA1412 in combination with pembrolizumab (Part C)
Time frame: Approximately 24 weeks
Change in biomarkers for KBA1412 monotherapy (Part A & B) and KBA1412 in combination with pembrolizumab (Part C) pre- and post-dose in tumor tissue
Time frame: Approximately 24 weeks
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 Sep 2025.
- Individual participant dataSharing planned: No
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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.
5 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 KBA1412 and Pembrolizumab in people with Advanced Solid Tumor Malignancy, run by Kling Biotherapeutics B.V. at 5 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 7 inclusion and 18 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 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands, Belgium. 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?
Part A & B & C: Frequency and severity of AEs as assessed by CTCAE v5.0 (time frame: Through study completion, an average of 1 year). The study lists 3 primary outcomes in all. 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 Sep 2025.