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

NCT06255964 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: IAP0971-201
• Study Type: interventional
• Target: 236
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• DLTs occurrence

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

  21 days

Secondary Outcomes (1)

• MTD

  21 days

Study Arms (3)

Phase Ia study

OTHER

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.

Drug: IAP0971

Phase Ib study

EXPERIMENTAL

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.

Combination Product: IAP0971＋BCG

Phase II study

EXPERIMENTAL

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.

Combination Product: IAP0971＋BCG

Interventions

IAP0971 DRUG

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

Phase Ia study

IAP0971＋BCG COMBINATION_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.

Phase Ib study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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:

You may not qualify if:

• 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:
• ). 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.
• \. 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.
• \. 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.
• \. 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.
• \. Patients who have received allogeneic stem cell or solid organ transplantation.
• \. 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).
• \. 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.
• \. 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.
• \. Patients who have serious or poorly controlled disease, including but not limited to:

Sponsors & Collaborators

• SUNHO（China）BioPharmaceutical CO., Ltd.: lead

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• ye dingwei, M.D.

  Cancer Hospital affiliated to Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

wang xinshi, B.D.

CONTACT

15105183989; wangxinshi@sunho-bio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2024
• First Posted: February 13, 2024
• Study Start: February 15, 2024
• Primary Completion: October 7, 2024
• Study Completion (Estimated): December 7, 2026
• Last Updated: February 13, 2024

Record last verified: 2024-02