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Monoclonal Antibodies

BT7480 + Nivolumab for Cancer

Phase 1 & 2
Recruiting
Research Sponsored by BicycleTx Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have a histologically or cytologically confirmed malignant solid tumor associated with Nectin-4 expression, including urothelial (transitional cell) carcinoma, head and neck squamous cell carcinoma, non-small cell lung cancer, and ovarian, breast, gastric, or esophageal carcinoma
Must have metastatic or locally advanced disease and measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 months
Awards & highlights

Study Summary

This trial is testing a new drug, BT7480, to see if it's safe and effective for treating cancer.

Who is the study for?
This trial is for adults with advanced solid tumors that express Nectin-4 and have not responded to standard treatments or have no suitable standard treatment options. Participants must be in relatively good health (ECOG score 0 or 1), have a life expectancy of at least 12 weeks, and provide tumor tissue samples.Check my eligibility
What is being tested?
The study tests the drug BT7480 alone and combined with nivolumab to determine safe dosages, side effects, effectiveness, how it affects the body, and its clearance. It also examines BT7480's impact on patients with reduced kidney function.See study design
What are the potential side effects?
Potential side effects include typical reactions associated with immunotherapy such as fatigue, skin reactions, inflammation in various organs which can cause symptoms like cough or diarrhea depending on the organ affected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer is confirmed to be linked with Nectin-4 expression.
Select...
My cancer has spread and can be measured by standard tests.
Select...
I can provide a recent or stored sample of my tumor.
Select...
I am mostly active and my organs and blood are functioning well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 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
Confirmed response rate as measured by clinical benefit rate (CBR) to demonstrate clinical activity following treatment with BT7480 in dose expansion phase
Confirmed response rate as measured by overall response rate (ORR) to demonstrate clinical activity following treatment with BT7480 in dose expansion phase
Number of patients with treatment emergent adverse events in dose escalation phase
Secondary outcome measures
Area under the plasma concentration-time curve (AUC) of BT7480
Confirmed response rate as measured by clinical benefit rate (CBR) to demonstrate clinical activity following treatment with BT7480 in dose escalation phase
Confirmed response rate as measured by overall response rate (ORR) to demonstrate clinical activity following treatment with BT7480 in dose escalation phase
+8 more

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533
57%
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%
Chills
7%
Hypertension
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Blood alkaline phosphatase increased
7%
Dehydration
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Musculoskeletal chest pain
5%
Malaise
5%
Pain
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%
Hypercalcaemia
1%
Neoplasm progression
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Circulatory collapse
1%
Bone pain
1%
Pericardial effusion malignant
1%
Atrial flutter
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

5Treatment groups
Experimental Treatment
Group I: BT7480 monotherapy in patients with renal insufficiencyExperimental Treatment1 Intervention
Participants will receive a selected dose of BT7480. It is expected that approximately 12 patients will participate in this dose confirmation arm.
Group II: BT7480 monotherapy dose expansionExperimental Treatment1 Intervention
Participants will receive a selected dose of BT7480. It is expected that approximately 45 patients will participate in this dose expansion arm in Phase 2.
Group III: BT7480 monotherapy dose escalationExperimental Treatment1 Intervention
Participants will receive increasing doses of BT7480. It is expected that approximately 80 patients will participate in this dose escalation arm.
Group IV: BT7480 and nivolumab dose expansionExperimental Treatment2 Interventions
Participants will receive a selected dose of BT7480 and standard dose of nivolumab. It is expected that approximately 45 patients will participate in this dose expansion arm in Phase 2.
Group V: BT7480 and nivolumab dose escalationExperimental Treatment2 Interventions
Participants will receive increasing doses of BT7480 and standard dose of nivolumab. It is expected that approximately 12 patients 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?

BicycleTx LimitedLead Sponsor
3 Previous Clinical Trials
1,573 Total Patients Enrolled

Media Library

BT7480 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05163041 — Phase 1 & 2
Solid Tumors Research Study Groups: BT7480 monotherapy in patients with renal insufficiency, BT7480 and nivolumab dose expansion, BT7480 monotherapy dose escalation, BT7480 and nivolumab dose escalation, BT7480 monotherapy dose expansion
Solid Tumors Clinical Trial 2023: BT7480 Highlights & Side Effects. Trial Name: NCT05163041 — Phase 1 & 2
BT7480 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05163041 — Phase 1 & 2

Frequently Asked Questions

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

What are the main goals of this clinical trial?

"The primary objective of this study, which will be monitored over a period of approximately 6 months from Cycle 1 Day 1 through study completion, is to confirm the response rate as measured by the clinical benefit rate (CBR) to demonstrate clinical activity following treatment with BT7480 in the dose expansion phase. Secondary objectives include progression free survival time in the dose escalation and dose expansion phases, which are defined as the duration of time from first drug administration to disease progression according to RECIST 1.1 criteria following treatment with BT7480 alone or in combination with nivolumab, and in patients with renal insufficiency; confirmed response rate"

Answered by AI

How many places are conducting this trial?

"There are 7 sites that are participating in this study. For example, Columbia University Irving Medical Center is based in New york while Fox Chase Cancer Center is in Philadelphia. MD Anderson Cancer Center is located in Houston and there are 4 other centres."

Answered by AI

Why do people usually take BT7480?

"BT7480 is a medication that oncologists can prescribe to patients with malignant neoplasms. Additionally, this drug helps people who have metastatic esophageal adenocarcinoma, unresectable melanoma, and squamous cell carcinoma."

Answered by AI

Is this a new kind of clinical trial?

"To date, there have been 747 active clinical trials for BT7480 across 2347 cities and 50 countries. The first trial was sponsored by Medarex and took place in 2010 with 127 patients. The study completed its Phase 1 drug approval stage. In the decade since the first trial, 249 more studies have been conducted."

Answered by AI

Are researchers currently looking for more participants for this trial?

"The most recent update on clinicaltrials.gov suggests that this research is recruiting patients as of right now. The study was originally posted on November 2nd, 2021 and updated August 16th, 2022."

Answered by AI

What is the previous research on BT7480?

"The first clinical trials for BT7480 were completed in 2010 at H. Lee Moffitt Cancer Center and Research Institute. To date, there have been a total of 249 completed clinical trials. Presently, 747 active trials are underway with many of these taking place in New york City."

Answered by AI

How many people are willing to try this new medication?

"This clinical trial requires 200 eligible patients in order to commence. The sponsor, BicycleTx Limited, plans to run the study from several locations including Columbia University Irving Medical Center and Fox Chase Cancer Center."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study BT7480-100 in Patients With Advanced Malignancies Associated With Nectin-4 Expression
2021. "Study BT7480-100 in Patients With Advanced Malignancies Associated With Nectin-4 Expression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05163041.
~71 spots leftby Sep 2025
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