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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
Exhausted all appropriate treatment options per local guidelines
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from cycle 1 day 1 (each cycle is 28 days) until disease progression or death or new anti-cancer therapy or loss of follow-up or withdrawal of consent (assessed every 8 weeks up to 6 months then every 16 weeks up to 12 months
Awards & highlights
Study Summary
This trial is testing a drug called BT5528 to see if it is safe and effective for treating various types of cancer.
Who is the study for?
Adults with advanced solid tumors known for high EphA2 expression, including ovarian, lung (NSCLC), triple-negative breast, gastric/GI, head and neck, and urothelial cancers. Participants must have tried all other treatments without success or be ineligible for them. They need proper organ function and agree to use effective contraception.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of a new drug called BT5528 alone and in combination with nivolumab against various advanced solid tumors. It aims to determine safe dosages, understand side effects better, and evaluate how well BT5528 works on these cancers.See study design
What are the potential side effects?
Potential side effects include typical reactions associated with cancer drugs such as immune-related issues due to nivolumab (like inflammation in organs), infusion reactions from BT5528 administration, fatigue, digestive problems like nausea or diarrhea, blood disorders that can affect cell counts leading to increased infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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I have tried all recommended treatments for my condition.
Select...
My cancer has spread, and I've tried all treatments without success.
Select...
I am not pregnant.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from cycle 1 day 1 (each cycle is 28 days) until disease progression or death or new anti-cancer therapy or loss of follow-up or withdrawal of consent (assessed every 8 weeks up to 6 months then every 16 weeks up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from cycle 1 day 1 (each cycle is 28 days) until disease progression or death or new anti-cancer therapy or loss of follow-up or withdrawal of consent (assessed every 8 weeks up to 6 months then every 16 weeks up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part A-1 and A-2 (escalations): Maximum tolerated dose (MTD) by the number of participants with dose limiting toxicities from BT5528 treatment alone and in combination with nivolumab
Part A-1 and A-2(escalations): Number of participants receiving BT5528 alone and in combination with nivolumab with treatment-emergent adverse events
Therapeutic procedure
+6 moreSecondary outcome measures
Plasma
All parts: Determine the plasma concentrations of MMAE in plasma from all participants taking BT5528 alone and in combination with nivolumab
All parts: Number of participants positive for anti-drug antibodies (ADA) from all participants receiving BT5528 alone and in combination with nivolumab
+14 moreSide effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Bronchitis
7%
Hypertension
7%
Chills
7%
Hyperkalaemia
7%
Dehydration
7%
Hyperglycaemia
7%
Blood alkaline phosphatase increased
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Rash maculo-papular
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Malignant pleural effusion
2%
Sepsis
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Cancer pain
1%
Small intestinal haemorrhage
1%
Confusional state
1%
Pneumothorax
1%
Atrial flutter
1%
Femur fracture
1%
Bone pain
1%
Neoplasm progression
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Hypercalcaemia
1%
Bronchial obstruction
1%
Superior vena cava syndrome
1%
Syncope
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab
Trial Design
3Treatment groups
Experimental Treatment
Group I: Phase II - Dose expansion 1 (BT5528)Experimental Treatment1 Intervention
A cohort of participants will receive the selected dose of BT5528 as a monotherapy. It is expected that up to 192 patients have solid tumors (Cohort 1: urothelial cancers, Cohort 2: ovarian cancer, Cohort 3: non-small cell lung cancer, Cohort 4: head and neck cancer, Cohort 5: triple-negative breast cancer, and Cohort 6: gastric/upper gastrointestinal cancer) historically known for high expression of EphA2 will participate in this dose-expansion arm
Group II: Phase I - Dose escalation combination (BT5528 & nivolumab)Experimental Treatment2 Interventions
Cohorts of participants will receive increasing doses of BT5528 and a standard dose of nivolumab. It is expected that up to 24 participants will participate in this dose-escalation combination arm.
Group III: Phase I - Dose escalation (BT5528)Experimental Treatment1 Intervention
Cohorts of participants will receive increasing doses of BT5528. It is expected that up to 72 participants will participate in this dose escalation arm.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
Bicycle Tx LimitedLead Sponsor
1 Previous Clinical Trials
329 Total Patients Enrolled
BicycleTx LimitedLead Sponsor
3 Previous Clinical Trials
1,485 Total Patients Enrolled
Hendrik-Tobias Arkenau, MD, PhDStudy ChairSarah Cannon Research Institute UK
1 Previous Clinical Trials
156 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not on medication that strongly affects certain liver enzymes or a specific drug transporter.I have brain metastases or leptomeningeal disease that hasn't been treated.I have not received a live vaccine in the last 30 days.I have a history of lung scarring or fibrosis.I am fully active or can carry out light work.I take more than 10 mg of prednisone or a similar strong immunosuppressant daily.I have been diagnosed with HIV/AIDS.You have taken any other experimental treatments within 4 weeks before starting BT5528.I am currently being treated for an infection.I haven't had chemotherapy or other cancer treatments in the last 14 days.My kidney, liver, blood, and clotting functions are normal.My doctor believes I have at least 12 weeks to live after starting BT5528 treatment.Any side effects from my previous treatments have mostly gone away.I have tried all recommended treatments for my condition.I had major surgery more than 4 weeks ago and have recovered enough to start treatment.My cancer has spread, and I've tried all treatments without success.I am not pregnant.I have urothelial cancer and was treated with enfortumab vedotin, but it progressed within 6 months.I am using or willing to use effective birth control methods.I am allergic to the trial medication or its components.My cancer is known to often show high levels of EphA2.I have hepatitis B but my viral load is undetectable with treatment.I have had an organ transplant.You have a condition that weakens your immune system.You have had a bad reaction to a type of medication that helps the immune system fight cancer.You are allergic to checkpoint inhibitor therapy.I have active hepatitis C or have been successfully treated for it.I haven't had blood clots or bleeding issues in the last 3 months.My blood pressure is very high and not controlled by treatment.I have had pneumonitis and still experience symptoms.I am 18 years old or older.You have a measurable disease according to specific guidelines.You have a history of autoimmune diseases, except for alopecia or vitiligo.I have signed and dated the consent form to participate in this study.I haven't had cancer, except for certain skin, cervical, or breast conditions, in the last 3 years.I haven't had a fever or taken antibiotics in the last 14 days.I can provide a sample of my tumor for testing, or I am willing to have a biopsy.
Research Study Groups:
This trial has the following groups:- Group 1: Phase I - Dose escalation combination (BT5528 & nivolumab)
- Group 2: Phase II - Dose expansion 1 (BT5528)
- Group 3: Phase I - Dose escalation (BT5528)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants is this trial capacity accommodating?
"To complete this research study, 312 patients who meet the selection criteria must be enlisted. These individuals can gain admittance at various centres such as Sidney Kimmel Cancer Center in Philadelphia and Barbara Ann Karmanos Cancer Institute in Detroit."
Answered by AI
Does the current research represent an unprecedented exploration in its field?
"At present, there are 718 active studies involving BT5528 across 2354 cities and 49 countries. Ono Pharmaceutical Co. Ltd's first trial of the drug began in 2012 with 659 participants finishing Phase 1 & 2 approval stages; 252 trials have been concluded since then."
Answered by AI
Are there numerous locations in our state currently conducting the experimental research?
"Currently, 15 medical centres across the US are enrolling patients for this trial. These sites include those in Philadelphia, Detroit and Providence as well as 12 additional locales. To reduce travel costs associated with participation, it is recommended to select a clinic nearest you."
Answered by AI
What other exploratory work has been done related to BT5528?
"Currently, 718 trials related to BT5528 are actively being conducted. Of those studies, 82 have reached Phase 3 and the vast majority of them take place in Basel, BE. However, clinical research on this drug is taking place all around the world with 40237 locations participating."
Answered by AI
What medical conditions are BT5528 commonly prescribed to address?
"BT5528 is frequently used to treat malignant tumors, but its efficacy extends beyond this cancer. This medication can also be administered for the management of unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."
Answered by AI
Is this clinical investigation currently recruiting participants?
"Affirmative, the information on clinicaltrials.gov implies that this medical trial is actively recruiting participants. The original posting date was November 7th 2019 and it has been recently updated to reflect current regulations on November 18th 2022. A total of 312 patients are required from 15 distinct sites across the nation."
Answered by AI
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