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Monoclonal Antibodies
BDB001 + Atezolizumab for Cancer
Phase 1
Waitlist Available
Research Sponsored by Eikon Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female participant not pregnant, not breastfeeding, and meets specified conditions
Be 18 years of age on day of signing informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 21 months
Awards & highlights
Study Summary
This trial is testing a new drug, BDB001, in combination with atezolizumab in people with advanced solid tumors. The goal is to find the best dose of BDB001 to give with atezolizumab.
Who is the study for?
Adults with advanced solid tumors that have worsened after treatment can join this trial. They must be over 18, not pregnant or breastfeeding, willing to use contraception, and have a life expectancy of at least 3 months. Participants need measurable disease progression and an ECOG score of 0-2. Those with severe heart conditions, recent major surgeries or therapies, active infections or certain other health issues are excluded.Check my eligibility
What is being tested?
The study is testing the safety and effects of increasing doses of BDB001 in combination with Atezolizumab on patients with advanced solid tumors. It's an early-phase trial (Phase 1) designed to find out what dose is safe and how the body responds to it.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as fatigue, skin reactions, inflammation in organs like lungs or intestines; infusion-related reactions from the drug administration; and potential interactions affecting liver enzymes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not pregnant, not breastfeeding, and meet the required conditions.
Select...
I am at least 18 years old.
Select...
My cancer has spread and gotten worse after treatment.
Select...
I am able to get out of my bed or chair and move around.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 21 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 21 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine Maximum Tolerated Dose (MTD) or recommended Phase 2 Dose (RP2D)
Safety and Tolerability: incidence of adverse events and any dose limiting toxicity
Secondary outcome measures
Radiographic Determination of Tumor Response after BDB001 in combination with atezolizumab dosing
Side effects data
From 2019 Phase 3 trial • 1225 Patients • NCT0200822736%
Fatigue
35%
Alopecia
24%
Diarrhoea
23%
Nausea
23%
Decreased appetite
22%
Anaemia
20%
Asthenia
19%
Cough
19%
Dyspnoea
16%
Myalgia
15%
Neutropenia
14%
Constipation
14%
Oedema peripheral
12%
Pyrexia
11%
Neuropathy peripheral
11%
Vomiting
11%
Stomatitis
10%
Arthralgia
9%
Rash
9%
Neutrophil count decreased
8%
Dysgeusia
8%
Paraesthesia
8%
Headache
7%
Pain in extremity
7%
Peripheral sensory neuropathy
7%
Insomnia
7%
Mucosal inflammation
7%
Back pain
6%
Pneumonia
6%
Febrile neutropenia
6%
Abdominal pain
6%
Dry skin
6%
Lacrimation increased
6%
Dizziness
5%
Haemoptysis
5%
Weight decreased
5%
Malaise
5%
Urinary tract infection
5%
Nail disorder
4%
Productive cough
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
3%
Pruritus
3%
Upper respiratory tract infection
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Influenza like illness
1%
Respiratory tract infection
1%
Musculoskeletal chest pain
1%
Lower respiratory tract infection
1%
Acute kidney injury
1%
Depression
1%
Lung infection
1%
Dehydration
1%
Chronic obstructive pulmonary disease
1%
Atrial fibrillation
1%
Syncope
1%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab
Trial Design
2Treatment groups
Experimental Treatment
Group I: Dose Expansion of BDB001 with atezolizumabExperimental Treatment2 Interventions
At the end of the dose escalation part of the study, the BDB001 dose to be used in combination with atezolizumab in the expansion part of the study will be established after thorough review of all available safety, preliminary efficacy, PK and PD data.
A biologically active dose will be selected that is either the MTD, if one was established in the escalation part, or an RP2D if no MTD was established. Approximately 20 additional subjects will initially be enrolled in the dose expansion part.
Group II: Dose Escalation of BDB001 with atezolizumabExperimental Treatment2 Interventions
This part of the study will follow a traditional 3+3 dose escalation design.
Each successive group of patients will be enrolled at an incrementally higher dosage until the Maximum Tolerable Dose (MTD) or Recommended Phase 2 Dose (RP2D) of BDB001 with atezolizumab is reached.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2017
Completed Phase 3
~5860
BDB001
2021
Completed Phase 2
~10
Find a Location
Who is running the clinical trial?
Eikon TherapeuticsLead Sponsor
5 Previous Clinical Trials
192 Total Patients Enrolled
Birdie Biopharmaceuticals HK LimitedLead Sponsor
2 Previous Clinical Trials
51 Total Patients Enrolled
Seven and Eight Biopharmaceuticals IncIndustry Sponsor
4 Previous Clinical Trials
299 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had pneumonitis treated with steroids or currently have it.I haven't taken steroids or immunosuppressants in the last 7 days.I am currently on medication for an infection.I have a history of lung scarring or fibrosis.I stopped my previous cancer treatment because of severe side effects.I have received an organ or tissue transplant from another person.I have not had cancer treatment in the last 3 weeks.I have not had major surgery in the last 4 weeks.I agree to use birth control during and for 4 months after my treatment.I have been diagnosed with HIV.I have been treated for an autoimmune disease in the last 2 years.I am not pregnant, not breastfeeding, and meet the required conditions.I am a woman who can have children and my pregnancy test is positive.I had radiotherapy less than 2 weeks before starting the study treatment.I have not received a live vaccine in the last 30 days.I have been treated with TLR 7 or TLR 9 agonists for my solid tumor.I am taking medication that strongly affects liver enzymes.I have another cancer that is getting worse or was treated in the last 3 years.I don't have any health issues that could affect the study's results.I am at least 18 years old.I have recovered from side effects of previous treatments, except for hair loss.My cancer has spread and gotten worse after treatment.My organs are functioning well.I have active brain metastases or cancer in my spinal fluid.I have had a severe heart condition in the past 6 months.I have an active hepatitis A, B, or C infection.I am able to get out of my bed or chair and move around.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Expansion of BDB001 with atezolizumab
- Group 2: Dose Escalation of BDB001 with atezolizumab
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.
Are there any vacancies available for this experiment?
"Whilst this clinical trial is not actively recruiting, its listing on clinicaltrials.gov indicates that it was last updated on July 6th 2022; and it has been available since November 21st 2019. Fortunately, there are 799 other trials enrolling patients at present."
Answered by AI
To what maladies does BDB001 typically bring relief?
"BDB001 is a commonly used pharmaceutical for treating small cell lung cancer. However, its usage extends beyond to malignant neoplasms, non-small cell lung carcinoma, and postoperative care as well."
Answered by AI
Could you please elucidate on other investigations involving BDB001?
"BDB001 was first investigated in 2008 at the SCRI Tennessee Oncology Chattanooga and since then, there has been a total of 80 completed clinical experiments. There are now 350 active trials with many being conducted from San Antonio, Texas."
Answered by AI
What is the maximum capacity of participants in this clinical research?
"At the moment, this particular clinical trial is not seeking enrolment. It was originally listed on November 21st 2019 and modified most recently on July 6th 2022. There are other trials open to participants with tumors or BDB001; currently 449 accept supplicants for solid tumours and 350 welcome applications regarding BDB001."
Answered by AI
What is the prevalence of this experiment in Canada?
"South Texas Accelerated Research Therapeutics (START), Angeles Clinic, and Tennessee Oncology are all part of the 5 medical institutions currently recruiting for this trial. Other centres participating in recruitment include three other locations."
Answered by AI
Is this trial an unprecedented endeavor?
"Investigated since 2008, BDB001's initial trial was conducted by Hoffmann-La Roche and included 720 patients. After achieving Phase 2 drug approval in the wake of this study, presently there are 350 concurrent trials occurring across 74 nations with 1646 cities participating."
Answered by AI
Has the FDA accepted BDB001 for public use?
"Our team at Power judged the safety of BDB001 to be a 1 due to its current standing as a Phase 1 trial, meaning that only preliminary data is available in regards to efficacy and risk."
Answered by AI
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