Bladder CancerPhase 1/2NCT04799847
Catumaxomab in Patients With Non-Muscle-Invasive Bladder Cancer Who Have Failed or Are Intolerant to BCG Vaccine
A Phase 1/2 study testing Catumaxomab in people with Bladder Cancer, run by LintonPharm Co.,Ltd. at 5 sites in China.
Trial summary
A Multicenter, Non-randomized, Uncontrolled, Open-label Phase I/II study to Observe the Safety and Preliminary Efficacy of Catumaxomab in Patients with Non-Muscle-Invasive Bladder Cancer who have Failed or are Intolerant to Bacillus Calmette-Guerin (BCG) Vaccine Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Catumaxomab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 5 sitesChina
- Study dates
- 23 Nov 2021to 30 Nov 2024
- Phase
- Phase 1/2
- 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
- Signed and dated informed consent forms have been provided.
- Willing to be complaint with the study procedures during the study.
- Male or female, age ≥ 18 years old when signing informed consents.
- Histologically or cytologically diagnosed as NMIBC, i.e., bladder cancer in the following pTNM status: pTis, pTa, pT1.
- Have received the standard therapy recommended in the current NMIBC clinical guidelines, including intravesical BCG instillation, and diagnosed as BCG failure or intolerance.
- Participants had completed TURBT or cystoscopy as required by guidelines prior to enrollment, and no significant tumours were seen in the surgical field Residual lesions
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- Recovered from any toxicity due to previous treatment (Grade 0-1 according to NCI-CTCAE v 5.0).
- Estimated life span is ≥ 6 months.
- Eastern Oncology Cooperative Group (ECOG) performance status 0-1.
- The laboratory test values during the screening period are in accordance with the following table:
- ANC(absolute neutrophil count)>=1.5x10^9/L
- Hemoglobin>=80 g/L
- Platelet>=100x10^9/L
- Lymphocyte percentage>=20%
- Serum Bilirubin <=1.25
- ULN(or 2.5 ULN if there is Gilbert)
- AST and ALT <=2.5 ULN without liver metastasis（or<=5 ULN if liver metastasis)
- Serum creatinine <=2.0 mg/dL or
- Calculated creatinine clearance>=30 mL/min.
- For women of childbearing potential: use an efficient method for contraception at least 1 month prior to screening and agree to use this method for contraception during the study period and 30 days after the last intravesical instillation.;
- For men with fertility potential: use condoms or other methods to ensure effective contraception for sexual partners from screening to 30 days after the last intravesical instillation.
Who cannot join
- Known or suspected of being allergic to catumaxomab or similar antibodies.
- Besides the TURBT + immediate postoperative infusion chemotherapy for this NMIBC recurrence, participants received other anti-tumor treatments, including other anti-tumor investigational drugs, chemotherapy, immunotherapy, biological agents, hormone therapy, radiation therapy (excluding local radiation therapy for pain relief), etc., the interval between the last instillation and the first intravesical instillation is ≤ 21 days.
- Tumor metastases outside the bladder confirmed in imaging examination.
- With other primary malignant tumors diagnosed before the signing of ICF, excluding squamous cell carcinoma in situ of skin or cervical carcinoma in situ without recurrence within 5 years after resection.
- The following diseases have not been resolved to CTCAE grade 0-1 in 3 days prior to the first instillation:
- Uncontrolled acute and chronic infections such as pneumonia, biliary infection, hepatitis B virus infection and hepatitis C virus infection, etc.
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- Dyspnea.
- Acute /chronic renal injury.
- Nephrotic syndrome.
- Bladder perforation.
- Urinary tract obstruction(except benign prostatic hypertrophy).
- NYHA Class 3 or 4.
- Related symptoms and signs of cardiovascular diseases have not been resolved to CTCAE grade 0-1: including myocardial infarction, congestive heart failure, and arrhythmia.
- Known cerebrovascular accidents have not been resolved to CTCAE grade 0-1.
- History of autoimmune diseases (eg, inflammatory bowel disease, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autologous hemolytic anemia, rheumatoid arthritis, etc.).
- Patients with known HIV serology positive, hepatitis C infection and/or hepatitis B (Except the patients with positive HepBsAg or core antibody are responding to anti-HBV treatment, they are allowed to participate in the study.
- Notes: HepBsAg-negative patients at screening, or patients are undergoing treatment with interferon-2a [IFN] or peginterferon-2a [Peg-IFN] and hepatitis B virus [HBV] DNA < 2000 international units [IU], or partients who are receiving nucleoside [acid] analogues at screening and HBV DNA below the lower limit of normal [LLN] are eligible to participate in the study.
- Pregnancy or breastfeeding during study treatment and follow-up period.
- Patients with confirmed past history of neurological or psychotic disorders, including epilepsy or dementia.
- Other serious systemic conditions that may limit the participation in this study (e.g. uncontrolled diabetes, cardiovascular and cerebrovascular disease, severe gastrointestinal disease, and renal disease, etc.).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Peking University Third Hospital
Beijing
Lulin Ma, 13701010872, malulin@medmail.com.cn
Lulin Ma
- Recruiting
The First Affiliated Hospital,Sun Yat-sen University
Guangzhou, Guangdong, 510080
Lingwu Chen, 13302283888, chenlingwu@hotmail.com
Lingwu Chen
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong
Jian Huang, 13600054833, hjgcp2017@163.com
Jian Huang
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou
Zhuowei Liu, 13610138571, liuzhw@sysucc.org.cn
Zhuowei Liu
- Recruiting
The Second Hospital of Tianjin Medical University
Tianjin
Hailong Hu, 13662096232, hhllove2004@163.com
Hailong Hu
About this study
Official title: A Multicenter, Non-randomized, Uncontrolled, Open-label Phase I/II Study to Observe the Safety and Preliminary Efficacy of Catumaxomab in Patients With Non-Muscle-Invasive Bladder Cancer Who Have Failed or Are Intolerant to BCG Vaccine
A Multicenter, Non-randomized, Uncontrolled, Open-label Phase I/II study to Observe the Safety and Preliminary Efficacy of Catumaxomab in Patients with Non-Muscle-Invasive Bladder Cancer who have Failed or are Intolerant to Bacillus Calmette-Guerin (BCG) Vaccine
Read the detailed description
This is a multicenter, non-randomized, uncontrolled, open-label phase I/II study to observe the safety and preliminary efficiency of catumaxomab in patients (hereinafter referred to as participants) with non-muscle-invasive bladder cancer (NMIBC) who have failed or are intolerant to Bacillus Calmette-Guerin (BCG) vaccine.
This study is conducted in 3 phases sequentially: dose escalation phase, dose expansion phase and dose extension phase. In the dose escalation phase, the preliminary safety and pharmacokinetic profile of catumaxomab for 4 cycles of instillation in 20ug group participants and 2cycles of instillation in 100ug group participants are explored. Data will be collected after completing DLT observation in all cohorts, but it is not required to lock database. DSMB will review the data of each dose cohort and decide whether to open the enrollment for the next cohort. DSMB will recommend the dose at dose expansion phase according to the relevant data after the completion of DLT observation and the first efficiency assessment.
In the dose expansion phase, 24 participants will receive the catumaxomab treatment at dosing scheme recommended by the DSMB. DLT events occurred within 28 days after the initial instillation will be investigated. After th DLT observation period, DSMB will evaluate the data from both dose escalation and dose expansion phase and decide whether to initiate the dose extension phase; protocol amendment might be developed.
In the dose extension phase, the elgible participants are enrolled and allocated into three arms according to the type of BCG treatment failure: refractory, relapse, and intolerance. A maximum 125 participants are enrolled in the 3 arms, with at least 30 participants allocated to each.
The participants will have chest and abdominal CT and pelvic MRI scan at baseline to determine the area of lesion and to rule out possible extra-bladder lesions. From the initial instillation, cystoscopy, bladder biopsy, urinary cytology, and pelvic MRI scan are performed every 12 weeks (±7 days); chest and abdominal CT scans are performed every 24 weeks (±7 days)1 until recurrence, progression, consent withdrawal, or 96 weeks (±7 days) from the initial instillation, whichever occurs firstly. Participants who discontinue study treatment early due to any reasons other than disease progression will continue to have the tumor response assessment as planned until the participant has disease progression, withdrawal of consent, loss of follow-up, death, 96 weeks (± 7 days) after the initial instillation or until the end of the study, whichever occurs firstly.
- Conditions
- Bladder Cancer
- Being tested
- Catumaxomab
- Keywords
- Bladder Cancer, Failed or are Intolerant to BCG Vaccine, catumaxomab
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CatumaxomabDrug
This study is conducted in 3 phases sequentially: dose escalation phase, dose expansion phase and dose extension phase. In the dose escalation phase, the preliminary safety and pharmacokinetic profile of catumaxomab by instillation, at 2 dose levels(20ug group and 100ug group）, in NMIBC patients are investigated.
| Study group | Role | What they receive |
|---|---|---|
| Catumaxomab | Experimental | In the dose escalation phase, 2 dose levels of catumaxomab will be explored. Receives: Drug: Catumaxomab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose escalation phase and dose expansion phase only: DLT incidence.
Dose Limited Toxicity
Measured: 28 days
1-year recurrence rate since the initial instillation
1-year recurrence rate since the initial instillation
Measured: 1 year
Secondary outcomes (9)
Recurrence rate at 3 months / 6 months / 2 years.
Recurrence rate at 3 months / 6 months / 2 year
Measured: Up to 2 years
PFS
Relapse-free survival
Measured: 2 years
2-year progression rate to MIBC.
2-year progression rate to MIBC.
Measured: 2 years
The incidence and severity of treatment-emergent adverse events (TEAEs) and Serious adverse event（SAE）
The incidence and severity of treatment-emergent adverse events (TEAEs) and Serious adverse event（SAE） during intravesical instillation with catumaxomab are observed according to the National Cancer Institute Common Terminology Standard for Adverse Events (NCI-CTCAE) v5.0.
Measured: 2 years
ADA
the incidence of anti-drug antibodies (ADA) to catumaxomab by intravesical instillation in serum.
Measured: 2 years
Pharmacokinetic parameters-Cmax
Pharmacokinetic parameters Cmax of bladder perfusion of Catumaxomab in plasma and urine
Measured: 2 years
Pharmacokinetic parameters-Cmin
Pharmacokinetic parameters Cmin of bladder perfusion of Catumaxomab in plasma and urine
Measured: 2 years
Pharmacokinetic parameters-AUC
Pharmacokinetic parameters-AUC of bladder perfusion of Catumaxomab in plasma and urine
Measured: 2 years
Pharmacokinetic parameters-t1/2
Pharmacokinetic parameters-t1/2 of bladder perfusion of Catumaxomab in plasma and urine
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start23 Nov 2021
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 161 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LintonPharm Co.,Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04799847
- Sponsor's protocol ID
- LP0190512
- Status last verified
- Feb 2023
- First submitted
- 12 Mar 2021
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Non-randomized, Uncontrolled, Open-label Phase I/II Study to Observe the Safety and Preliminary Efficacy of Catumaxomab in Patients With Non-Muscle-Invasive Bladder Cancer Who Have Failed or Are Intolerant to BCG Vaccine
- ClinicalTrials.gov ID
- NCT04799847
- Acronym / sponsor ID
- LP0190512
- Conditions
- Bladder Cancer
- Keywords
- Bladder Cancer, Failed or are Intolerant to BCG Vaccine, catumaxomab
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 161 participants (estimated)
- Lead sponsor
- LintonPharm Co.,Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Nov 2021 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 16 Mar 2021 (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.
A Multicenter, Non-randomized, Uncontrolled, Open-label Phase I/II study to Observe the Safety and Preliminary Efficacy of Catumaxomab in Patients with Non-Muscle-Invasive Bladder Cancer who have Failed or are Intolerant to Bacillus Calmette-Guerin (BCG) Vaccine
Detailed description
This is a multicenter, non-randomized, uncontrolled, open-label phase I/II study to observe the safety and preliminary efficiency of catumaxomab in patients (hereinafter referred to as participants) with non-muscle-invasive bladder cancer (NMIBC) who have failed or are intolerant to Bacillus Calmette-Guerin (BCG) vaccine.
This study is conducted in 3 phases sequentially: dose escalation phase, dose expansion phase and dose extension phase. In the dose escalation phase, the preliminary safety and pharmacokinetic profile of catumaxomab for 4 cycles of instillation in 20ug group participants and 2cycles of instillation in 100ug group participants are explored. Data will be collected after completing DLT observation in all cohorts, but it is not required to lock database. DSMB will review the data of each dose cohort and decide whether to open the enrollment for the next cohort. DSMB will recommend the dose at dose expansion phase according to the relevant data after the completion of DLT observation and the first efficiency assessment.
In the dose expansion phase, 24 participants will receive the catumaxomab treatment at dosing scheme recommended by the DSMB. DLT events occurred within 28 days after the initial instillation will be investigated. After th DLT observation period, DSMB will evaluate the data from both dose escalation and dose expansion phase and decide whether to initiate the dose extension phase; protocol amendment might be developed.
In the dose extension phase, the elgible participants are enrolled and allocated into three arms according to the type of BCG treatment failure: refractory, relapse, and intolerance. A maximum 125 participants are enrolled in the 3 arms, with at least 30 participants allocated to each.
The participants will have chest and abdominal CT and pelvic MRI scan at baseline to determine the area of lesion and to rule out possible extra-bladder lesions. From the initial instillation, cystoscopy, bladder biopsy, urinary cytology, and pelvic MRI scan are performed every 12 weeks (±7 days); chest and abdominal CT scans are performed every 24 weeks (±7 days)1 until recurrence, progression, consent withdrawal, or 96 weeks (±7 days) from the initial instillation, whichever occurs firstly. Participants who discontinue study treatment early due to any reasons other than disease progression will continue to have the tumor response assessment as planned until the participant has disease progression, withdrawal of consent, loss of follow-up, death, 96 weeks (± 7 days) after the initial instillation or until the end of the study, whichever occurs firstly.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Catumaxomab | Experimental | Drug: CatumaxomabIn the dose escalation phase, 2 dose levels of catumaxomab will be explored. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Signed and dated informed consent forms have been provided.
- Willing to be complaint with the study procedures during the study.
- Male or female, age ≥ 18 years old when signing informed consents.
- Histologically or cytologically diagnosed as NMIBC, i.e., bladder cancer in the following pTNM status: pTis, pTa, pT1.
- Have received the standard therapy recommended in the current NMIBC clinical guidelines, including intravesical BCG instillation, and diagnosed as BCG failure or intolerance.
Key exclusion criteria (20 listed)
- Known or suspected of being allergic to catumaxomab or similar antibodies.
- Besides the TURBT + immediate postoperative infusion chemotherapy for this NMIBC recurrence, participants received other anti-tumor treatments, including other anti-tumor investigational drugs, chemotherapy, immunotherapy, biological agents, hormone therapy, radiation therapy (excluding local radiation therapy for pain relief), etc., the interval between the last instillation and the first intravesical instillation is ≤ 21 days.
- Tumor metastases outside the bladder confirmed in imaging examination.
- With other primary malignant tumors diagnosed before the signing of ICF, excluding squamous cell carcinoma in situ of skin or cervical carcinoma in situ without recurrence within 5 years after resection.
- The following diseases have not been resolved to CTCAE grade 0-1 in 3 days prior to the first instillation:
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 |
|---|---|---|
| CatumaxomabThis study is conducted in 3 phases sequentially: dose escalation phase, dose expansion phase and dose extension phase. In the dose escalation phase, the preliminary safety and pharmacokinetic profile of catumaxomab by instillation, at 2 dose levels(20ug group and 100ug group）, in NMIBC patients are investigated. | Drug | Catumaxomab |
Primary outcome
Dose escalation phase and dose expansion phase only: DLT incidence.
Time frame: 28 days
Dose Limited Toxicity
1-year recurrence rate since the initial instillation
Time frame: 1 year
1-year recurrence rate since the initial instillation
9 secondary outcomes
Recurrence rate at 3 months / 6 months / 2 years.
Time frame: Up to 2 years
PFS
Time frame: 2 years
2-year progression rate to MIBC.
Time frame: 2 years
The incidence and severity of treatment-emergent adverse events (TEAEs) and Serious adverse event（SAE）
Time frame: 2 years
ADA
Time frame: 2 years
Pharmacokinetic parameters-Cmax
Time frame: 2 years
Pharmacokinetic parameters-Cmin
Time frame: 2 years
Pharmacokinetic parameters-AUC
Time frame: 2 years
Pharmacokinetic parameters-t1/2
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
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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 First Affiliated Hospital,Sun Yat-sen University
Guangzhou, China
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Catumaxomab in people with Bladder Cancer, run by LintonPharm Co.,Ltd. at 5 sites in China.
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 21 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 13 Feb 2023. 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 China. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose escalation phase and dose expansion phase only: DLT incidence. (time frame: 28 days). 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?
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 13 Feb 2023.