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Bladder CancerPhase 1/2NCT06255964

A Study of IAP0971 in Combination With Bacillus Calmette Guerin in High Risk Non-muscular Invasive Bladder Cancer

A Phase 1/2 study testing IAP0971 and IAP0971＋BCG in people with Bladder Cancer, run by SUNHO（China）BioPharmaceutical CO., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The efficacy and safety of IAP0971 single drug or combined with BCG intravesical instillation in the treatment of high-risk non muscle invasive bladder cancer with BCG treatment failure. 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?
IAP0971 and IAP0971＋BCG
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
236 participants
Where
No sites listed yet
Study dates
15 Feb 2024to 7 Dec 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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

  • Age ≥ 18 years on the day of signing informed consent form.
  • Patients who have NMIBC which is confirmed by cystoscopy, urine cytology and histopathology examination within 12 weeks prior to the first dose, and is classified as high risk according to the Guideline of Non-muscle Invasive Bladder Cancer issued by European Association of Urology (EAU) (version 2021)
  • CIS patients must have CIS on the tumor sample from the most recent cystoscopy/TURBT.
  • Patients who have papillary tumors (Ta and T1), a complete TURBT must have been performed, as characterized by:
  • -Attainment of a visually complete resection of all papillary tumors (Ta and T1);
  • -Residual CIS, therefore not amenable to complete transurethral resection is acceptable;
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  • The most recent cystoscopy/TURBT must have been performed within 12 weeks prior to the first dose.
  • Patients who have received and failed BCG intravesical instillation therapy prior to enrollment and are ineligible for radical cystectomy or elect not to undergo the procedure.
  • Failure of BCG therapy including: BCG refractory tumor, BCG relapsing tumor, BCG unresponsive tumor
  • Patients who have elected not to undergo the radical cystectomy or are ineligible for the procedure on the investigator's judgment. The reasons for ineligible or refusal of radical cystectomy should be discussed with the patient as part of the informed consent and should be documented on the appropriate case report form. Ineligibility factors for radical cystectomy include, but are not limited to:
  • -Patients have cardiovascular disease (e.g., recent acute coronary syndrome, cardiac arrhythmias, heart failure);
  • -Patients have chronic obstructive pulmonary disease that would preclude a safe surgical procedure, as determined by the treating surgeon;
  • -Patients have undergone major abdominal and pelvic surgery that would preclude a safe surgical procedure, as determined by the treating surgeon.
  • Patients who have a performance status of 0 or 1 on the ECOG performance scale
  • Adequate organ function during the screening period, include:
  • -Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L;
  • -Hemoglobin (Hgb) ≥ 80 g/L;
  • -Platelets (PLT) ≥ 100 × 10^9/L;
  • -ALT and AST ≤ 2.5 × ULN, or ≤ 5.0 × ULN for subject with liver metastases;
  • Total bilirubin (TBIL) ≤ 1.5×ULN;
  • Serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance ≥ 30 mL/min according to the Cockcroft Gault formula
  • All premenopausal women and women within 12 months of menopause with a negative serum pregnancy test;
  • Left ventricular ejection fraction (LVEF) ≥ 50%;
  • Prothrombin time (PT) or international normalized ratio (INR) ≤ 1.5 x ULN, unless the subject is receiving anticoagulant therapy. Patients should be waited for at least 1 week to do the above tests if they have received thrombopoietin and/or granulocyte colony-stimulating factor.
  • Expected survival time of more than 6 months
  • Eligible patients of childbearing potential (men and women) must agree to use a reliable method of contraception (including intrauterine device, contraceptive or condom for females; condom or abstinence for males) with their partners prior to the study entry, during the trial, and for at least 180 days after completion of treatment. In addition, female patients should be non-lactating.
  • Patients must be informed of the study prior to the trial and voluntarily sign a written informed consent form.

Who cannot join

  • Patients who are known allergy or intolerance to investigational product, BCG or excipients.
  • Patients who have muscle-invasive bladder cancer (T2-T4) confirmed.
  • Patients who have concurrent extra-vesical (i.e., urethral, ureter or renal pelvis) non-muscle invasive transitional cell carcinoma of the urothelium.
  • Patients who have a history of vesicoureteral reflux.
  • Patients who have not recovered from toxicity reactions associated with prior antitumor therapy except for fatigue and alopecia (determination criteria: toxicity remains > Grade 1 or has not returned to baseline levels).
  • Patients who have severe or uncontrollable cardiac diseases which need to be treated, including:
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  • 1). patients with severe arrhythmias (ventricular arrhythmias which requires clinical intervention, second to third degree of atrioventricular block, etc.); 2). patients with a medical history of myocardial infarction, unstable angina, angioplasty, or coronary artery bridging surgery within 6 months prior to the first dose of the investigational product; 3). patients with Class III or IV of congestive heart failure classified by NYHA 4). corrected QTc interval is > 450 ms for men and > 470 ms for women (calculated by the Fridericia formula) by 12-lead ECG at screening.
  • 7. Patients who have received intravesical instillation therapy within 28 days prior to the first dose (patients are allowed to have immediate chemotherapeutic instillation in the past and after the current electrodesiccation); 8. Patients who have received antitumor therapy such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, biologic therapy and herbal medicine within 28 days or 5 half-lives of the drug (whichever is longer) prior to the first dose.
  • 9. Patients who have participated in any other clinical trial (except for patients at overall survival follow-up) within 28 days or 5 half-lives of the drug (whichever is longer) prior to the first dose.
  • 10. Patients who have additional malignancy that have had progression or requires active treatment in the last 3 years. Exceptions include, but are not limited to, in situ cervical cancer, superficial or non-invasive bladder cancer, basal cell carcinoma, in situ squamous cell carcinoma, or gastrointestinal tumors confined to the mucosal layer and that have been endoscopically resected.
  • 11. Patients who have received allogeneic stem cell or solid organ transplantation.
  • 12. Patients who have received any live/attenuated vaccine within 4 weeks or blood transfusion within 2 weeks prior to enrollment. 13. Patients who have received extensive radiotherapy to the pelvis (> 30% of the bone marrow area).
  • 14. Patients who have an active autoimmune disease that have required systemic therapy in the past 2 years (i.e., with use of corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic therapy.
  • 15. Patients who have a diagnosis of immunodeficiency or are receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the planned first dose. The use of physiologic doses of corticosteroids may be approved after consultation with the sponsor.
  • 16. Patients who have serious or poorly controlled disease, including but not limited to:
  • . active tuberculosis (with clinical signs, physical examination findings or radiographic findings of active tuberculosis);
  • . hepatitis B virus (HBV) infection with HBV DNA positive (>upper limit of detection values in the site), hepatitis C virus (HCV) infection with HCV RNA positive (>upper limit of detection values in the site), and human immunodeficiency virus (HIV) test positive;
  • . uncontrolled hypertension after treatment (defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg);
  • . severe and uncontrollable pulmonary disease (severe infectious pneumonia, interstitial lung disease, etc.) (≥Grade 3, CTCAE);
  • . uncontrolled all types of serious infections (≥Grade 3, CTCAE), including active or refractory urinary tract infections.
  • . ascites, pleural effusion or pericardial effusion requiring drainage prior to first study drug therapy.
  • 17. Patients with known history of psychiatric disorder, substance abuse, drug and alcohol use that would interfere with the subject's ability to cooperate with the requirements of the trial.
  • 18. Patients who are inappropriate for participation in this trial in the opinion of the investigator.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

wang xinshi, B.D. contact

15105183989

wangxinshi@sunho-bio.com

About this study

Official title: A Phase I/II Clincal Trial of Intravesical IAP0971 in Combination With Bacillus Calmette Guerin (BCG) in Patients With BCG Unresponsive High Risk Non-Muscular Invasive Bladder Cancer (NMIBC)

The efficacy and safety of IAP0971 single drug or combined with BCG intravesical instillation in the treatment of high-risk non muscle invasive bladder cancer with BCG treatment failure.

Read the detailed description

Phase Ia study: for adults with BCG treatment failure or intolerance to BCG, high-risk non muscle invasive bladder cancerPatient, evaluate the safety and tolerability of IAP0971 monotherapy bladder infusion, and determine dose limiting toxicity and/or phase II recommended dose.

Phase Ib study:To evaluate the safety and tolerability of intravesical IAP0971 in combination with BCG in patients with BCG unresponsive high risk non-muscle invasive bladder cancer, and to determine the DLT and RP2D.

Phase II study:To evaluate the efficacy of intravesical IAP0971 in combination with BCG in patients with BCG unresponsive high risk NMIBC using RP2D as determined in the phase I study.

Conditions
Bladder Cancer
Being tested
IAP0971, IAP0971＋BCG
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.

  • IAP0971Drug

    Induction period (6 weeks): IAP0971 single drug bladder infusion, once a week;Maintenance period: IAP0971 single drug bladder infusion, performed at 3, 6, 12, 18, and 24 months, once a week, for 3 consecutive times

  • IAP0971＋BCGCombination product

    Induction period (6 weeks): IAP0971 combined with BCG,Bladder perfusion, once a week;Maintenance period: IAP0971 combined with BCG bladder perfusion,Maintain at months 3, 6, 12, 18, and 24Perfusion, once a week, three times in a row.

  • IAP0971＋BCGCombination product

    Induction period (6 weeks): IAP0971 combined with BCG,Bladder perfusion, once a week;Maintenance period: IAP0971 combined with BCG bladder irrigationNote, progress at months 3, 6, 12, 18, and 24Perform maintenance perfusion once a week, three times in a row.

Study groups in NCT06255964
Study groupRoleWhat they receive
Phase Ia studyOtherPhase Ia study: for adults with BCG treatment failure or intolerance to BCG, high-risk non muscle invasive bladder cancerPatient, evaluate the safety and tolerability of IAP0971 monotherapy bladder infusion, and determine dose limiting toxicity and/or phase II recommended dose.
Receives: Drug: IAP0971
Phase Ib studyExperimentalPhase Ib study:To evaluate the safety and tolerability of intravesical IAP0971 in combination with BCG in patients with BCG unresponsive high risk non-muscle invasive bladder cancer, and to determine the DLT and RP2D.
Receives: Combination Product: IAP0971＋BCG
Phase II studyExperimentalPhase II study:To evaluate the efficacy of intravesical IAP0971 in combination with BCG in patients with BCG unresponsive high risk NMIBC using RP2D as determined in the phase I study.
Receives: Combination Product: IAP0971＋BCG

What is being measured

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

  1. DLTs occurrence

    The DLT evaluation period is defined as 21 days after the first administration of investigational product.

    Measured: 21 days

Secondary outcomes (1)

  1. MTD

    During DLT evaluation period, if ≥2 cases DLTs occur in the 3 or 6 subjects in one dose group, the previous dose is defined as MTD.

    Measured: 21 days

Timeline

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

  1. First posted13 Feb 2024
  2. Study start15 Feb 2024 (estimated)
  3. Primary completion7 Oct 2024 (estimated)
  4. Study completion7 Dec 2026 (estimated)

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
236 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06255964
Sponsor's protocol ID
IAP0971-201
Status last verified
Feb 2024
First submitted
4 Feb 2024
Last updated
13 Feb 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing IAP0971 and IAP0971＋BCG in people with Bladder Cancer, run by SUNHO（China）BioPharmaceutical CO., Ltd..

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 27 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: opening soon, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact wang xinshi, B.D. (15105183989, wangxinshi@sunho-bio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLTs occurrence (time frame: 21 days). 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 NCT06255964.

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 2024.

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