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BT5528 for Solid Cancers

Phase 1 & 2

Recruiting

Research Sponsored by Bicycle Tx Limited

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

Must not have

Current treatment with strong inhibitors or inducers of CYP3A4 or strong inhibitors of P-gp

Untreated CNS metastases or leptomeningeal disease

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

No Placebo-Only Group

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.

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.

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 below

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I am fully active or can carry out light work.

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I have tried all recommended treatments for my condition.

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My cancer has spread, and I've tried all treatments without success.

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I am not pregnant.

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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:

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I am not on medication that strongly affects certain liver enzymes or a specific drug transporter.

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I have brain metastases or leptomeningeal disease that hasn't been treated.

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I have not received a live vaccine in the last 30 days.

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I have a history of lung scarring or fibrosis.

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I take more than 10 mg of prednisone or a similar strong immunosuppressant daily.

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I have been diagnosed with HIV/AIDS.

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I am currently being treated for an infection.

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Any side effects from my previous treatments have mostly gone away.

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I had major surgery more than 4 weeks ago and have recovered enough to start treatment.

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I am allergic to the trial medication or its components.

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I have had an organ transplant.

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I haven't had blood clots or bleeding issues in the last 3 months.

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My blood pressure is very high and not controlled by treatment.

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I have had pneumonitis and still experience symptoms.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 more

Secondary study objectives

Plasma

All parts: Determine the plasma concentrations of MMAE in plasma from all participants taking BT5528 alone and in combination with nivolumab

Part A-1 and A-2 (escalations): Clinical benefit rate (CBR) by RECIST 1.1 in participants with advanced solid tumors with high EphA2 levels receiving BT5528 alone and in combination with nivolumab

+13 more

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717

80%

Fatigue

70%

Diarrhoea

70%

Headache

40%

Vomiting

40%

Aspartate aminotransferase increased

40%

Rash maculo-papular

40%

Alanine aminotransferase increased

40%

Lipase increased

30%

Partial seizures

30%

Hemiparesis

30%

Gait disturbance

30%

Fall

30%

Cough

30%

Dry skin

30%

Amylase increased

30%

Nausea

30%

Confusional state

20%

Malignant neoplasm progression

20%

Pyrexia

20%

Candida infection

20%

Mucosal infection

20%

Decreased appetite

20%

Back pain

20%

Dysphonia

20%

Hypotension

20%

Colitis

20%

Hyperthyroidism

20%

Oedema peripheral

20%

Muscular weakness

20%

Hypothyroidism

10%

Tinnitus

10%

Cushingoid

10%

Diabetic ketoacidosis

10%

Procedural haemorrhage

10%

Blood bilirubin increased

10%

Bradycardia

10%

Sinus tachycardia

10%

Hyperglycaemia

10%

Hypocalcaemia

10%

Neck pain

10%

Brain oedema

10%

Hydrocephalus

10%

Lethargy

10%

Seizure

10%

Hypertension

10%

Palpitations

10%

Cheilitis

10%

Presyncope

10%

Face oedema

10%

Oedema

10%

Conjunctivitis

10%

Enterocolitis infectious

10%

Oral candidiasis

10%

Pneumonia

10%

Sinusitis

10%

Staphylococcal infection

10%

Blood alkaline phosphatase increased

10%

Spinal pain

10%

Tremor

10%

Dizziness

10%

Dysarthria

10%

Urinary retention

10%

Dyspnoea exertional

10%

Nasal congestion

10%

Pneumonitis

10%

Dermatitis

10%

Erythema

10%

Rash

10%

Klebsiella infection

10%

Hypomagnesaemia

10%

Syncope

10%

Haemorrhage intracranial

10%

Pancreatitis

10%

Cholecystitis

10%

Upper respiratory tract infection

10%

Acute kidney injury

10%

Dermatitis bullous

10%

Lymphopenia

10%

Optic nerve disorder

10%

Visual impairment

10%

Dehydration

10%

Hypokalaemia

10%

Scoliosis

10%

Cognitive disorder

10%

Memory impairment

10%

Hallucination

10%

Insomnia

10%

Irritability

10%

Urinary incontinence

10%

Dyspnoea

10%

Dermatitis acneiform

10%

Pelvic venous thrombosis

10%

Sepsis

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 1: Arm N1+I3

Cohort 2: Arm B

Part A Cohort 1c: Arm N3+RT+TMZ

Part A Cohort 1d: Arm N3+RT

Part B Cohort 1c: Arm N3+RT+TMZ

Part B Cohort 1d: Arm N3+RT

Cohort 1: Arm N3

Cohort 1b: Arm N3+I1

Cohort 2: Arm N3

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 164 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, Cohort 7: urothelial MMAE exposed, Cohort 8: head and neck squamous cell carcinoma

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

2015

Completed Phase 3

~4010

0 / 19Eligibility criteria met