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Urinary Bladder NeoplasmsPhase 1NCT04819399

Investigation of Safety and Tolerability of Catumaxomab in Patients With NMIBC

A Phase 1 study testing Catumaxomab in people with Urinary Bladder Neoplasms, run by Lindis Biotech GmbH at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study is to investigate the safety, tolerability, and preliminary efficacy of the monoclonal bispecific trifunctional antibody Catumaxomab in patients with non-muscle invasive bladder cancer (NMIBC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urinary Bladder Neoplasms
What is being tested?
Catumaxomab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteGermany
Study dates
7 Jul 2020to 30 Sep 2025
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

  • Patients will be enrolled in this Phase I study only if they meet all of the following criteria:
  • Male or non-pregnant, non-breastfeeding female, age 18 years or older at date of consent.
  • Any of the following histologically confirmed non-muscle invasive urothelial carcinoma of the bladder:
  • High-risk tumors according to EAU guidelines:
  • pT1
  • G3 HG tumors
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  • CIS
  • Multiple, recurrent and large (>3cm) pTa G1-G2 LG tumors (all features must be present)
  • Patients of the subgroup of highest risk tumours (T1G3/HG associated with concurrent bladder CIS, multiple- and/or large T1G3/HG and/or recurrent T1G3/HG, T1G3/HG with CIS in the prostatic urethra, some forms of variant histology of urothelial carcinoma, lymphovascular invasion) will be only enrolled if they have already failed BCG-treatment or they cannot tolerate it and are ineligible or refuse cystectomy. In the Part II of the study a minimal expression of EpCAM in the tumor tissue may be required, based on preliminary evidence from the Part I of the study
  • Previous therapies must be discontinued at least 2 weeks prior to administration of Catumaxomab and all treatment related toxicities must have resolved or decreased to common toxicity criteria (CTCAE) grade 1.
  • Time period from primary resection to antibody treatment start must be at least one week and should not exceed 2 weeks.
  • Any investigational agent must be discontinued at least 4 weeks or 5 half-lives, whichever is longer, prior to antibody treatment start.
  • Female patients of child-bearing potential (for definition refer to section 14.3)must:
  • have negative serum pregnancy test prior to study treatment to rule out pregnancy.
  • Use at least one method of birth control that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), true sexual abstinence or vasectomized partner from the time of signing the informed consent through 2 weeks after the last study drug treatment.
  • All sexually active patients agree to use barrier contraception (i.e., condoms) while receiving study treatment and for 2 weeks following their last dose of study treatment.
  • Adequate organ function, as defined by the following criteria:
  • Aspartate aminotransferase / serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase / serum glutamic pyruvate transaminase (ALT/SGPT) ≤ 3.0 x upper limit of normal (ULN);
  • Total serum bilirubin ≤ 1.5 x ULN (CTCAE Grade ≤ 1);
  • Serum creatinine ≤ 1.5 x ULN; or a creatinine clearance ≥40 ml/min
  • Alkaline phosphatase < 2.5 x ULN
  • Adequate hematological, liver and kidney function:
  • Hemoglobin ≥8.0 g/dL;
  • Absolute neutrophil count ≥1500/mm3;
  • Platelets ≥75,000mm3(= 75 G/l)
  • Activated Partial thromboplastin time (aPTT) within limits of normal • Signed and dated informed consent/assent form

Who cannot join

  • Patients will not be enrolled in this Phase I study if they meet any of the following criteria:
  • The female patient is pregnant, lactating or breastfeeding or has a positive serum pregnancy test during the screening period.
  • Low risk or intermediate risk tumors according to EAU guidelines
  • History or signs (obstruction of upper urinary tract or cross hematuria in the ureteral orifice) of urethral or upper tract transitional cell carcinoma (TCC). Patients with T1 disease of the bladder must have no evidence of upper or lower tract disease or a more advanced stage of disease by either computed tomography (CT) urography or magnetic resonance imaging (MRI) urography of the abdomen and pelvis performed within 8 weeks before the first application of study treatment. If intravenous contrast medium for CT and MRI is contraindicated, retrograde ureteropyelography, or CT or MRI without intravenous contras tmedia may be performed.
  • Patients with hydronephrosis.
  • Any intravesicular or other chemotherapy treatment within 2 weeks or any investigational agent within 4 weeks or 5 half-lives of the agent whatever is longer prior to the initial dose of study drug
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  • History of recurrent severe urinary tract infections (UTIs) per investigator judgment.
  • Active, uncontrolled impairment of the urogenital, renal, hepatobiliary, cardiovascular, gastrointestinal, neurologic or hematopoietic systems which, in the opinion of the investigator, would predispose the patient to the development of complications from the administration of intravesical therapy.
  • A diagnosis of another malignancy within 2 years before the first dose of study treatment, except for superficial skin cancer or localized solid tumors deemed cured by surgery and not treated with systemic anticancer therapy and not expected to require anticancer therapy within the next 2 years i.e., while the patient may be taking study treatment or is in the follow up period of this study.
  • Patients with a history of cancer who have completed treatment and are free from disease since at least 5 years can be enrolled.
  • Patients with low-risk prostate cancer, e.g.:
  • Clinically localized disease (≤T2a) and
  • Gleason score ≤6 (3+3) and
  • Serum PSA <10 ng/ml undergoing active surveillance may be enrolled with agreement of the sponsor.
  • Patients who cannot tolerate intravesical administration or intravesical surgical manipulation (cystoscopy, biopsy) due to the presence of serious comorbid condition(s) (e.g., uncontrolled cardiac or respiratory disorders).
  • Known hypersensitivity to Catumaxomab and its analogues in general, or to any other component of the study drug formulation.
  • Documented acute or chronic infection including known hepatitis B or C or HIV infection or other concurrent non-malignant co morbidities such as unstable or uncontrolled pectoral angina, myocardial infarction during the last 6 months, valvular heart disease that requires treatment, acute myocarditis or congestive heart failure (CHF) (New York Heart Association (NYHA) III or IV).
  • Any concurrent chemotherapy, radiotherapy (except for local radiation therapy for bone metastasis), immunotherapy or corticoid therapy.
  • Any other concurrent disease or medical conditions that are deemed to interfere with the conduct of the study as judged by the investigator.
  • Participation in any of the following types of clinical studies either concurrently or within the previous 28 days or within 5 half-lives of any investigational pharmacologic agents, whichever is longer: pharmacologic agents or imaging materials, including dyes, investigational surgical techniques or devices. Participation in studies of psychology, or socioeconomic issues is allowed.
  • Unwilling or unable to follow protocol requirements.
  • Legal incompetence or limited legal competence, or detainment in an institution due to official or legal reasons
  • Involvement in the conduct and/or the design of the study (applies to sponsor's staff or staff in treating centres)

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Urologie Planegg

    München

Other trials in Germany

About this study

Official title: Phase I, Open Label, Dose Escalating Study to Investigate Safety and Tolerability of Intravesical Application of Trifunctional Anti-EPCAM x Anti-CD3 Antibody Catumaxomab in Patients With Non-muscle Invasive Bladder Cancer (NMIBC)

The purpose of the study is to investigate the safety, tolerability, and preliminary efficacy of the monoclonal bispecific trifunctional antibody Catumaxomab in patients with non-muscle invasive bladder cancer (NMIBC).

Read the detailed description

The present Phase I dose escalation study (CATUNIBLA) in patients with non-muscle invasive bladder cancer (NMIBC) of high and intermediate risk for progression aims at investigating the therapeutic potential of Catumaxomab applied as intravesical instillation. Catumaxomab is an intact trifunctional bispecific monoclonal antibody and has the molecular targets EpCAM and CD3. It mediates antibody-dependent cellular cytotoxicity against human epithelial tumor cells including bladder cancer.

The study consists of two parts: Part I is dose finding and will investigate 3 sequential cohorts consisting of 3 patients to be enrolled at the specified dose levels. After determination of the dose for Part II an additional number (n=X) of patients will be included at this dose level. Part I and part II have a screening period, 6 week treatment phase and a follow-up phase.

Being tested
Catumaxomab
Keywords
Non Muscle Invasive Bladder Cancer, NMIBC, Catumaxomab, Intravesical
Medical subject headings
Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CatumaxomabDrug

    Procedure: 6 weekly intravesical administration at each dose level; 3 sequential cohorts consisting of 3 patients (part I)

    1. cohort 50 µg
    2. cohort 70 µg
    3. cohort 100 µg

    Part II will be treated at recommended dose

Study groups in NCT04819399
Study groupRoleWhat they receive
CatumaxomabExperimentalintravesical Catumaxomab instillation
Receives: Drug: Catumaxomab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose escalation phase to evaluate DLT incidence

    Dose Limited Toxicity

    Measured: approximately 1 year after study start

  2. Incidence and severity of treatment related adverse events

    Incidence and severity of treatment related adverse events during intravesical instillation with catumaxomab are observed according to NCI CTCAE, Version 5.0

    Measured: approximately 2.5 years after study start

Secondary outcomes (15)

  1. Anti-drug antibodies (ng/ml)

    the incidence of ADA (anti-drug antibodies to catumaxomab by intravesical instillation in serum

    Measured: approximately 2.5 years after study start

  2. Cytokines (pg/mL)

    cytokines (pg/mL)

    Measured: approximately 2.5 years after study start

  3. Number of EpCAM-positive tumor cells in the urine

    • number of EpCAM-positive tumor cells in the urine

    Measured: approximately 2.5 years after study start

  4. Number of immune cells in the urine

    • number of immune cells in the urine

    Measured: approximately 2.5 years after study start

  5. Cmax (ng/ml)

    PK parameter of Catumaxomab is Cmax (ng/ml)

    Measured: approximately 2.5 years after study start

  6. Cmin (ng/ml)

    PK parameters of Catumaxomab is Cmin (ng/ml)

    Measured: approximately 2.5 years after study start

  7. Tmax (hours)

    PK parameter of Catumaxomab is Tmax (hours)

    Measured: approximately 2.5 years after study start

  8. AUC (day * ng/ml)

    PK parameters of Catumaxomab AUC (day * ng/ml)

    Measured: approximately 2.5 years after study start

  9. t1/2 (days)

    PK parameter of Catumaxomab t1/2 (days)

    Measured: approximately 2.5 years after study start

  10. Antitumor activity

    antitumor activities is assessed by cystoscopy and biopsy/or resection at EoT (day 43) and all follow up visits and measures and documents tumor size, tumor localization, tumor numbers and morphological criteria

    Measured: approximately 2.5 years after study start

  11. Complete response

    Complete response will be defined as no histological evidence of disease at 3-monthly evaluations

    Measured: approximately 2.5 years after study start

  12. Recurrence-free interval

    recurrence-free interval is evaluated following the catumaxomab treatment in the follow up phase 3 month to 2 years

    Measured: approximately 2.5 years after study start

  13. Local progression free interval

    local progression free interval is evaluated following the catumaxomab treatment in the follow up phase 3 month to 2 years

    Measured: approximately 2.5 years after study start

  14. Identification and quantification of tumor cells in urine

    this is evalulated at screening and in the course of the study

    Measured: approximately 2.5 years after study start

  15. EpCAM expression

    Evaluation of potential and predictive EpCAM expression and relative Lymphocytes count can be correlated with outcome

    Measured: approximately 2.5 years after study start

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2021
  2. Study start7 Jul 2020
  3. Primary completion31 Aug 2025
  4. Study completion30 Sep 2025

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04819399
Sponsor's protocol ID
CATUNIBLA
Other IDs
2019-002850-22, 2019
Status last verified
Oct 2026
First submitted
18 Mar 2021
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Catumaxomab in people with Urinary Bladder Neoplasms, run by Lindis Biotech GmbH at 1 site in Germany.

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 26 inclusion and 23 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 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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?

Dose escalation phase to evaluate DLT incidence (time frame: approximately 1 year after study start). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04819399.

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 16 Oct 2026.

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