New antibody shows promise in early cancer trial

NCT ID NCT05501821

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tested a new drug called KBA1412, a lab-made antibody that targets a protein on cancer cells. It was given alone or with another cancer drug (pembrolizumab) to 16 adults with advanced solid tumors that had stopped responding to standard treatments. The main goals were to check safety and see if the drug could shrink tumors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

16 people

The number who actually took part.

Started

Aug 2022

Finished

Jul 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: * 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 Exclusion criteria: * 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 * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Dutch Cancer Institute AVL

    Amsterdam, 1066 CX, Netherlands

  • Erasmus Medical Center Rotterdam

    Rotterdam, 3015 GD, Netherlands

  • University Hospital Antwerp

    Antwerp, 2650, Belgium

  • University Hospital Ghent

    Ghent, 9000, Belgium

  • University Hospital Leiden (LUMC)

    Leiden, 2333 ZA, Netherlands

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