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Monoclonal Antibodies
BDB001 + Pembrolizumab for Cancer
Phase 1
Waitlist Available
Research Sponsored by Birdie Biopharmaceuticals HK Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be 18 years of age on day of signing informed consent
Eastern Cooperative Oncology Group (ECOG) score of 0 - 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 months
Awards & highlights
Study Summary
This trial is testing the safety and effectiveness of an immunotherapy drug, given alone or with another immunotherapy drug, in people with advanced solid tumors.
Who is the study for?
Adults with advanced solid tumors that have worsened after all other treatments or who cannot tolerate standard treatments can join this trial. They must not be pregnant, agree to use contraception, and have a life expectancy of at least 3 months. Participants need measurable disease progression and adequate organ function but cannot have had certain recent treatments or severe allergies to similar drugs.Check my eligibility
What is being tested?
The study is testing BDB001 alone and combined with Pembrolizumab in patients with advanced solid tumors. It's an early-phase trial where the safety, tolerability, and best dose of BDB001 are being determined when given on its own or alongside Pembrolizumab.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system such as inflammation in various organs, fatigue, skin reactions, digestive issues like nausea or diarrhea, potential liver problems indicated by blood tests changes, and increased risk for infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am at least 18 years old.
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 30 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and Tolerability: incidence of adverse events and any dose limiting toxicity
Secondary outcome measures
Determine Maximum Tolerated Dose
Radiographic Determination of Tumor Response after BDB001 Dosing
Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
2Treatment groups
Experimental Treatment
Group I: Single Agent BDB001Experimental Treatment1 Intervention
A single subject will be enrolled at each dose level in the single agent arm until any ≥ Grade 2 treatment-emergent adverse event (TEAE) is observed in the first cycle.
Then dosage escalation 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 single agent BDB001 is reached.
Group II: BDB001 in Combination with PembrolizumabExperimental Treatment2 Interventions
In the combination arm of the study, a standard 3+3 dose escalation design will be utilized for all dose levels.
When the MTD or RP2D of single agent BDB001 is reached, the first dose level cohort of the combination arm will begin. Once the MTD or RP2D in combination has been determined, twenty additional subjects will be enrolled in the expansion phase of the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BDB001
2021
Completed Phase 2
~10
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Birdie Biopharmaceuticals HK LimitedLead Sponsor
2 Previous Clinical Trials
41 Total Patients Enrolled
Seven and Eight Biopharmaceuticals IncIndustry Sponsor
4 Previous Clinical Trials
289 Total Patients Enrolled
Eikon TherapeuticsLead Sponsor
5 Previous Clinical Trials
182 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken steroids or immunosuppressants in the last week.I have received an organ or tissue transplant from another person.I have previously been treated with specific immune system drugs for my current cancer.I stopped a cancer immunotherapy due to severe side effects.I am at least 18 years old.My advanced cancer has worsened after all treatments, or I cannot tolerate/refuse them.I am able to get out of my bed or chair and move around.I have a history of lung scarring or fibrosis.I haven't had serious heart issues like heart failure or a heart attack in the last 6 months.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I have not received a live vaccine in the last 30 days.My brain metastases are stable, and I haven't needed steroids for 14 days.I had radiotherapy over 2 weeks ago, recovered from side effects, and didn't have lung inflammation from it.I am not pregnant or breastfeeding and either can't have children or will use effective birth control.I agree to use birth control and not donate sperm for 120 days after my last treatment.I have hepatitis but my viral load is low and liver function is within required limits.I have not had major surgery in the last 4 weeks.I have not had active treatment for another cancer, except for certain skin cancers or in situ cervical cancer, in the last 3 years.I haven't had cancer treatment or experimental drugs in the last 21 days.I am taking strong medications that affect liver enzymes.I am currently being treated for an infection.I have had or currently have lung inflammation treated with steroids.My cancer can be measured on scans, even if it's in an area that was previously treated with radiation.My organs are functioning well according to recent tests.
Research Study Groups:
This trial has the following groups:- Group 1: BDB001 in Combination with Pembrolizumab
- Group 2: Single Agent BDB001
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.
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