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BRIEF TITLE: A Phase Ib Study of APL-1202 in NMIBC Patients Who Are Resistant to One Induction Course of BCG Treatment

A Phase Ib Study of APL-1202 in NMIBC Patients Who Are Resistant to One Induction Course of BCG Treatment


  • Org Study ID: YHGT-NB-01
  • Secondary ID:
  • NCT ID: NCT03672240
  • NCT Alias:
  • Sponsor: Asieris Pharmaceutical Technologies Co., Ltd. - Industry
  • Source: Asieris Pharmaceutical Technologies Co., Ltd.

Brief Summary

A Phase Ib, open label, non randomized study to measure the safety and PK characteristics of APL-1202 at steady-state in adult male and female BCG resistant NMIBC patients when it is administered alone and concurrently with BCG.

Detailed Description


Six eligible participants will be administered with APL-1202 one week prior to the first BCG
instillation, during the six-week course of BCG instillation, and additional five weeks, for
a total of 12 weeks of dosing. Safety assessment will be performed during the entire 13 week
study duration. Plasma and urine samples will be collected from each participant at prior to
first and fifth BCG instillations for PK analysis.

Overal Status Start Date Phase Study Type
Recruiting November 30, 2018 Phase 1/Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Incidence and Severity of Treatment-Related Adverse Events

Primary Outcome 1 - Time Frame: 13 weeks

Condition:

  • Non-Muscle Invasive Bladder Cancer (NMIBC)

Eligibility

Criteria:
Inclusion Criteria:

- BCG-resistant NMIBC, defined as persistent carcinoma in situ (CIS) or recurring
papillary tumor and/or CIS within twelve months after the first BCG induction dose
(BCG plus interferon induction was allowed), and warrant additional BCG therapies in
the opinion of the Investigator

- Subjects must be able to enter into the study between 14-60 days from their most
recent diagnostic procedure

- 18 years of age or older

- Eastern Cooperative Oncology Group (ECOG) performance status < 2

- Not pregnant or lactating

- Subjects with child bearing or fathering potential must agree to use adequate
contraception during the study and for 3 months after last treatment of
investigational drug.

- Agree to study specific informed consent and Health Insurance Portability and
Accountability Act (HIPAA) authorization for release of personal health information

- Adequate baseline complete blood count (CBC), renal and hepatic function

- Parameters described as WBC > 3000 cells/mm3, ANC > 1,000 cells/mm3, hemoglobin > 8.5
g/dL, and platelet count >100,000 cells/mm3

- Adequate renal function: serum creatinine < 1.5 x upper limit of normal (ULN)

- Bilirubin, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are not
more than 2 x Upper Limits of Normal

- Prothrombin time and International Normalized Ratio (PT/INR), Partial thromboplastin
time (PTT), and fibrinogen within institutional acceptable limits

- Absolute lymphocyte count ≥ 800/μL before the first dose of APL-1202

Exclusion Criteria:

- Stage T2 or above urothelial carcinoma or urothelial carcinoma outside the bladder

- Stage T1 NMIBC recurred at 3 months or shorter from the first dose of prior induction
BCG course

- Previous systemic immunotherapy for bladder cancer

- Prior major surgery (not Transurethral Resection of Bladder Tumor [TURBT/Cystoscopy]),
radiation therapy, or systemic therapy within 8 weeks of starting the study treatment

- National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE)
Grade 3 hemorrhage within four weeks from the starting study treatment

- Any of the following medical conditions within the six months prior to investigational
drug administration: myocardial infarction, severe/unstable angina,
coronary/peripheral artery bypass graft, symptomatic congestive heart failure,
cerebrovascular accident or transient ischemic attack, or pulmonary embolism

- Hypertension that cannot be controlled by medications

- Optic nerve disorders or with a history of optic nerve disorders

- Other severe acute or chronic medical or psychiatric condition, or laboratory
abnormality that may increase the risk associated with study participation or
investigational drug administration, or may interfere with the interpretation of study
results in the judgment of the Investigator

- Clinically meaningful allergic reactions or any known hypersensitivity or prior
reaction to any of the formulation components in the investigational drug

- Systemic treatment on any investigational clinical trial within 28 days (or 5
half-lives of that agent, whichever is greater) prior to enrollment

- Concurrent treatment with immunosuppressive or immunomodulatory agents, including any
systemic steroid (exception: inhaled or topically applied steroids, and acute and
chronic standard dose nonsteroidal anti-inflammatory drugs (NSAIDs), are permitted).
Use of a short course (i.e., ≤ 2 day) of a glucocorticoid is acceptable to prevent a
reaction to the IV contrast used for: computed tomography (CT) scans

- Immunosuppressive therapy, including: cyclosporine, anti thymocyte globulin, or
tacrolimus within three months of study entry

- History of stage III or greater cancer, excluding urothelial cancer. Basal or squamous
cell skin cancers must have been adequately treated and the subject must be
disease-free at the time of registration. Subjects with a history of stage I or II
cancer, must have been adequately treated and have been disease free for ≥ 2 years at
the time of enrollment

- Progressive or persistent viral or bacterial infection

- All infections must be resolved, and the subject must remain afebrile for seven days
without antibiotics prior to enrollment

- Urinary tract infection, including particularly bladder infection, must be resolved
prior to being placed on study

- Unmanageable Active gastric ulcer or inflammation of gastrointestinal (GI) tract

- Gastric bleeding within last 6 months prior to enrollment

- Anuria

- Unable to take oral medication

- Unwilling or unable to comply with the protocol or cooperate fully with the
Investigator and site personnel

- Unwilling to sign the informed consent
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Gender: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Healthy Volunteers: No

Official Information

Name: Harish Dave, MD

Role: Study Chair

Affiliation: Linical Accelovance

Overall Contact

Name: Olivia Longacre

Phone: ‭(520) 404-1995‬

Email: olongacre@asieris.com

Location

Facility Status Contact
Urology Center PC
Omaha, Nebraska 68118
United States
Recruiting