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APL-1202 + Tislelizumab for Bladder Cancer (ANTICIPATE Trial)
Phase 1 & 2
Waitlist Available
Research Sponsored by Jiangsu Yahong Meditech Co., Ltd aka Asieris
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histopathologically confirmed transitional cell carcinoma of the bladder. Patients with mixed histologies are required to have a dominant (i.e. > 50%) transitional cell pattern
Radical cystectomy is planned (according to local guidelines)
Must not have
Evidence of measurable nodal or metastatic disease
Significant cardiovascular disease, such as New York Heart Association cardiac disease (more than Class II), myocardial infarction within 3 months prior to enrollment, unstable arrhythmias, or unstable angina
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 26 months
Summary
This trial is testing a new combination therapy for patients with bladder cancer who are ineligible or refuse cisplatin-based chemotherapy.
Who is the study for?
This trial is for adults with muscle invasive bladder cancer who can't have or don't want cisplatin-based chemotherapy. They must be planning to have their bladder removed, not have had previous systemic cancer therapy, and agree to use contraception. People with significant uncontrolled diseases, recent major surgeries, certain allergies or autoimmune diseases, other cancers within the last 5 years, or active infections are excluded.
What is being tested?
The trial tests APL-1202 in combination with tislelizumab versus tislelizumab alone as a pre-surgery treatment for bladder cancer patients ineligible for cisplatin chemo. It aims to assess safety and effectiveness of this combo and how it affects tumor markers.
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions like fever or chills during drug administration, fatigue, potential liver issues indicated by blood test changes and increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My bladder cancer is mostly transitional cell type.
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I am scheduled for a major bladder surgery as recommended.
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I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My cancer has spread and can be measured.
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I do not have serious heart problems like recent heart attacks or unstable heart rhythms.
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I have an untreated hepatitis infection.
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I have active tuberculosis.
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I haven't taken more than 10 mg/day of steroids like prednisone in the last 4 weeks.
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I haven't been in a clinical trial or taken experimental drugs in the last 4 weeks.
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I have or had an optic nerve disorder.
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I have not had severe infections or been hospitalized for infection complications in the last 4 weeks.
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I do not have any major health issues that could interfere with the study.
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I haven't had major surgery in the last 4 weeks and don't expect to need any during the study.
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I have been diagnosed with idiopathic pulmonary fibrosis.
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I haven't taken any immune-boosting drugs in the last 4 weeks.
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I have had a previous transplant of stem cells or an organ.
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I am allergic to certain medications made in Chinese hamster ovary cells.
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I have a history of autoimmune disease.
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My Type 1 diabetes is not under control.
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I have high calcium levels in my blood that require treatment.
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I have or had a cataract.
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I have been treated with drugs targeting PD-1 or PD-L1.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 26 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adverse events (AE) and serious adverse events (SAE).
The RP2D of APL-1202 in combination with tislelizumab.
The rate of pathologic complete response (pCR) in Phase 2.
Secondary study objectives
AUC
Cmax
Cumulative amount in urinary excretion (Ae)
+8 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: APL-1202 in combination with tislelizumabActive Control1 Intervention
Group II: Tislelizumab alonePlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
Jiangsu Yahong Meditech Co., Ltd aka AsierisLead Sponsor
6 Previous Clinical Trials
1,442 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread and can be measured.I have or had an optic nerve disorder.I have active tuberculosis.I haven't been in a clinical trial or taken experimental drugs in the last 4 weeks.I have not had severe infections or been hospitalized for infection complications in the last 4 weeks.I do not have any major health issues that could interfere with the study.I haven't had major surgery in the last 4 weeks and don't expect to need any during the study.I have been diagnosed with idiopathic pulmonary fibrosis.I have not received a vaccine in the last 4 weeks and do not expect to need one during the study.I haven't taken any immune-boosting drugs in the last 4 weeks.My bladder cancer is mostly transitional cell type.I haven't taken more than 10 mg/day of steroids like prednisone in the last 4 weeks.I am scheduled for a major bladder surgery as recommended.I am 18 years old or older.I have had treatment for bladder cancer that went through my whole body.I do not have serious heart problems like recent heart attacks or unstable heart rhythms.I have had a previous transplant of stem cells or an organ.I am allergic to certain medications made in Chinese hamster ovary cells.You have a history of serious allergic reactions to certain types of medications made from antibodies or proteins.I have an autoimmune thyroid condition but am on a stable medication dose.I have a history of autoimmune disease.My Type 1 diabetes is not under control.I haven't had cancer other than bladder cancer in the last 5 years, except for certain low-risk types.I have high calcium levels in my blood that require treatment.I have or had a cataract.I have been treated with drugs targeting PD-1 or PD-L1.I have an untreated hepatitis infection.You have tested positive for HIV.
Research Study Groups:
This trial has the following groups:- Group 1: APL-1202 in combination with tislelizumab
- Group 2: Tislelizumab alone
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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