BT7480 for Solid Tumors, Advanced Solid Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Solid Tumors, Advanced Solid Tumors+1 More
BT7480 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Solid Tumors, Advanced Solid Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Solid Tumors, Advanced Solid Tumors

Study Objectives

4 Primary · 12 Secondary · Reporting Duration: At 6 months

At 6 months
Progression free survival time in dose escalation and dose expansion phase
Month 6
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 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 escalation phase
Confirmed response rate as measured by overall response rate (ORR) to demonstrate clinical activity following treatment with BT7480 in dose expansion phase
Cumulative amount of BT7480 excreted in the urine
Level of CD137 target engagement in all patients
Maximum plasma concentration (Cmax) of BT7480
Number of participants positive for anti-drug antibodies (ADA)
Terminal half life (t1/2) of BT7480 in plasma
Day 28
Number of patients with treatment emergent adverse events in dose escalation phase
Number of patients with treatment emergent adverse events in dose expansion phase
Month 6
Therapeutic procedure
Therapeutic procedure
Month 6
Duration of response to assess clinical activity in dose escalation and dose expansion phase

Trial Safety

Safety Progress

1 of 3

Other trials for Solid Tumors, Advanced Solid Tumors

Side Effects for

NIVOLUMAB 3 mg/kg
38%Fatigue
29%Nausea
28%Decreased appetite
25%Cough
25%Diarrhoea
24%Dyspnoea
20%Vomiting
19%Constipation
14%Anaemia
14%Weight decreased
13%Malignant neoplasm progression
13%Aspartate aminotransferase increased
13%Arthralgia
13%Back pain
13%Pruritus
12%Pyrexia
12%Rash
11%Oedema peripheral
10%Dizziness
10%Myalgia
10%Productive cough
10%Abdominal pain
9%Non-cardiac chest pain
9%Alanine aminotransferase increased
9%Hypoalbuminaemia
9%Hyponatraemia
9%Headache
8%Asthenia
7%Hypothyroidism
7%Upper respiratory tract infection
7%Hypokalaemia
7%Musculoskeletal pain
6%Insomnia
6%Chills
6%Nasopharyngitis
6%Lymphocyte count decreased
6%Blood alkaline phosphatase increased
6%Hyperglycaemia
6%Musculoskeletal chest pain
6%Pain in extremity
6%Haemoptysis
6%Dry skin
6%Dyspepsia
5%Dysgeusia
5%Hypomagnesaemia
5%Rash maculo-papular
4%Pneumonia
4%Blood creatinine increased
4%Muscular weakness
3%Stomatitis
3%Chest pain
3%Hypophosphataemia
3%Dysphonia
3%Pneumonitis
2%Pleural effusion
2%Pulmonary embolism
2%Mucosal inflammation
2%Peripheral sensory neuropathy
2%Alopecia
2%Lung infection
2%Pericardial effusion malignant
2%Epistaxis
1%Acute coronary syndrome
1%Adrenal insufficiency
1%General physical health deterioration
1%Hypersensitivity
1%Urinary tract infection
1%Hip fracture
1%Infusion related reaction
1%Gamma-glutamyltransferase increased
1%Dehydration
1%Hypercalcaemia
1%Pathological fracture
1%Malignant pleural effusion
1%Cancer pain
1%Lung neoplasm malignant
1%Cerebrovascular accident
1%Confusional state
1%Metastases to spine
1%Syncope
1%Chronic obstructive pulmonary disease
1%Renal failure
1%Pneumothorax
1%Respiratory failure
1%Pulmonary haemorrhage
1%Deep vein thrombosis
1%Lacrimation increased
1%Neutropenia
1%Thrombocytopenia
1%Platelet count decreased
1%Neutrophil count decreased
1%Colitis
1%Cholecystitis acute
1%Sepsis
1%Lower respiratory tract infection
1%Metastases to central nervous system
1%Tumour pain
1%Seizure
1%White blood cell count decreased
This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT02041533) in the NIVOLUMAB 3 mg/kg ARM group. Side effects include: Fatigue with 38%, Nausea with 29%, Decreased appetite with 28%, Cough with 25%, Diarrhoea with 25%.

Trial Design

5 Treatment Groups

BT7480 and nivolumab dose escalation
1 of 5
BT7480 monotherapy in patients with renal insufficiency
1 of 5
BT7480 monotherapy dose escalation
1 of 5
BT7480 monotherapy dose expansion
1 of 5
BT7480 and nivolumab dose expansion
1 of 5
Experimental Treatment

200 Total Participants · 5 Treatment Groups

Primary Treatment: BT7480 · No Placebo Group · Phase 1 & 2

BT7480 and nivolumab dose escalationExperimental Group · 2 Interventions: Nivolumab, BT7480 · Intervention Types: Drug, Drug
BT7480 monotherapy in patients with renal insufficiency
Drug
Experimental Group · 1 Intervention: BT7480 · Intervention Types: Drug
BT7480 monotherapy dose escalation
Drug
Experimental Group · 1 Intervention: BT7480 · Intervention Types: Drug
BT7480 monotherapy dose expansion
Drug
Experimental Group · 1 Intervention: BT7480 · Intervention Types: Drug
BT7480 and nivolumab dose expansionExperimental Group · 2 Interventions: Nivolumab, BT7480 · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 6 months

Who is running the clinical trial?

BicycleTx LimitedLead Sponsor
2 Previous Clinical Trials
641 Total Patients Enrolled
1 Trials studying Solid Tumors, Advanced Solid Tumors
329 Patients Enrolled for Solid Tumors, Advanced Solid Tumors

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have an ECOG performance status score of 0 or 1 and acceptable organ and hematological function.
You have radiographically documented metastatic or locally advanced disease per RECIST 1.1
You have a life expectancy of at least 12 weeks.\n
You must provide written informed consent, according to local guidelines, signed and dated by the patient or by a legal guardian prior to the performance of any study-specific procedures, sampling, or analysis.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 8th, 2021

Last Reviewed: October 20th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.