← Back to Search

Other

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
Patients who refuse neoadjuvant cisplatin based chemotherapy or in whom neoadjuvant cisplatin based therapy is contraindicated. Contraindications to cisplatin is defined by meeting at least one of the following criteria: Impaired renal function with calculated CrCl 30 to 59 mL/min (by Cockcroft-Gault equation), Eastern Cooperative Oncology Group (ECOG) Performance Status 2, CTCAE v.5 Grade ≥2 audiometric hearing loss, In the clinical judgement of the investigator, potential adverse effects from cisplatin-based neoadjuvant chemotherapy outweighs its benefits, Clinical stage T2-T4a N0 M0 disease by CT (or MRI) (within 4 weeks of randomization), Residual disease after transurethral resection of bladder (TURB) (surgical opinion, cystoscopy or radiological presence), Availability of representative formalin-fixed paraffin-embedded (FFPE) tumor specimens or unstained slides, with an associated pathology report, and determined to be evaluable for tumor PD-L1 expression prior to study enrollment, Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, Adequate hematologic and end-organ functions: Hemoglobin > 9.0 g/dL, Absolute neutrophil count (ANC) > 1.5×109 /L, Platelet count > 100×109 /L, Serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN), Aspartate aminotransferase (AST) /alanine aminotransferase (ALT) ≤ 2.5 x institutional upper limit of normal ULN, CrCl (calculated using Cockcroft-Gault equation) ≥ 30 mL/min (calculated CrCl ≥ 50 mL/min in Phase Ⅰ: Dose-Escalation), INR < 1.5. This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose, Female patients should be surgically sterilized or post-menopausal or must agree to take effective contraceptive measures during the treatment, Male patients must be surgically sterilized or must agree to take effective contraceptive measures during treatment, Patients must continue to take contraceptive measures for 3 months after the investigational therapy was completed
Histopathologically confirmed transitional cell carcinoma of the bladder. Patients with mixed histologies are required to have a dominant (i.e. > 50%) transitional cell pattern
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 26 months
Awards & highlights

ANTICIPATE Trial 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.Check my eligibility
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.See study design
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.

ANTICIPATE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My bladder cancer is mostly transitional cell type.
Select...
I am scheduled for a major bladder surgery as recommended.
Select...
I am 18 years old or older.

ANTICIPATE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 26 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
AUC
Cmax
Cumulative amount in urinary excretion (Ae)
+8 more

ANTICIPATE Trial 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

APL-1202 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04813107 — Phase 1 & 2
Bladder Cancer Research Study Groups: APL-1202 in combination with tislelizumab, Tislelizumab alone
Bladder Cancer Clinical Trial 2023: APL-1202 Highlights & Side Effects. Trial Name: NCT04813107 — Phase 1 & 2
APL-1202 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04813107 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this research still ongoing?

"As indicated by clinicaltrials.gov, this medical study is still open for recruitment as of today. It was initially posted on December 28th 2021 and has been updated more recently on February 21st 2022."

Answered by AI

Is there precedent for this kind of clinical trial?

"As of present, there are 105 active trials for APL-1202 combined with tislelizumab in 426 cities and 45 nations. The first trial was conducted by BeiGene in 2017 and involved 805 participants who completed its Phase 3 approval phase. Following the initial run, a further 11 studies have been concluded."

Answered by AI

How many participants are being incorporated in this research experiment?

"Affirmative. Clinicaltrials.gov presents evidence that this research is in the midst of recruitment, with 79 volunteers sought from 1 site since its first posting on December 28th 2021 and last editing on February 21st 2022."

Answered by AI

What is the major goal of this clinical test?

"This protocol will track two primary outcomes over a 26 month period: adverse events (AE) and serious adverse events (SAE). Secondary measurements include Tmax, Ae%, and plasma ctDNA-based tumor mutation burdens (TMB)."

Answered by AI

Are there any other investigations conducted regarding the concomitant use of APL-1202 and tislelizumab?

"At present, there are 105 active clinical trials for APL-1202 and tislelizumab therapy, with 18 of those studies in their final phase. Trials are being conducted mainly in Nanning, Guangxi; however, 2329 other locations also have these experiments underway."

Answered by AI
~24 spots leftby Mar 2025