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Phase 1/2 Study of BDC-1001 as a Single Agent and in Combination with Nivolumab in Patients with Advanced HER2-Expressing Solid Tumors
EU CTIS ID: 2024-518411-19-00
What this study is testing
Dose Escalation (Part 1 and Part 2): To define the safety and tolerability of BDC-1001 as monotherapy (Part 1) and in combination with nivolumab (Part 2) in patients with advanced HER2-expressing solid tumors. To determine the RP2D for BDC-1001 as monotherapy (Part 1) and in combination with nivolumab (Part 2) in patients with advanced HER2-expressing solid tumors. Dose Expansion (Parts 3 and 4): To evaluate preliminary antitumor activity of BDC-1001 as monotherapy (Part 3) and in combination with nivolumab (Part 4) in patients with advanced HER2+ solid tumors.
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- For Part 1 and Part 2: a. Patient has an advanced solid tumor for which approved therapies have been exhausted or for which the Investigator considers the patient ineligible or intolerant of other forms of treatment b. Tumor has documented HER2 expression (including both HER2-low and HER2+). At least 1 of the first 3 patients evaluated for DLT in Cohort M2 and all subsequent cohorts in Part 1 requires documented HER2 protein expression (IHC2+ or IHC3+) in tumor tissue.
- Willing and able to provide blood samples prior to the start of this study
- At least 4 weeks post-op from prior major surgery
- Laboratory values at Screening must be according to protocol.
- Women of childbearing potential should use a ‘highly effective contraceptive measure’ (a method that can achieve a failure rate of less than 1% per year) during treatment and until 7 months after the end of treatment
- Potent men who are partners of women of childbearing potential must be willing to use condoms in combination with a second highly effective method (as above) of female contraception during the study and until 7 months after the end of treatment. A male partner will be considered as potent unless surgically sterilized (with appropriate documentation of sterility).
You likely can't join if
- Exclusion Criteria (Section 4.2): 1. For Part 2 and Part 4 with BDC-1001 and nivolumab combination therapy: a. Patient has a history of immune-mediated colitis. b. Patient has an active autoimmune disease with the exception of auto-immune endocrinopathies that are stable on hormone replacement therapy. c. History of allergy or hypersensitivity to nivolumab components. d. History of life-threatening toxicity related to prior immune therapy (eg, anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) or anti-programmed death 1 (PD-1)/programmed death ligand 1 (PD-L1) (PD-1/ PD-L1) treatment or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) except those that are unlikely to re-occur with standard countermeasures (eg, Hypothyroidism).
- Patient has had an organ transplantation.
- Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to C1D1 (ie, participants with a history of prior malignancy are eligible if treatment was completed at least 2 years before C1D1 and the patient has no evidence of disease). Participants with history of prior early stage basal/squamous cell skin cancer or non-invasive or in situ cancers that have undergone definitive treatment at any time are also eligible.
- Patient has an active, known, or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- Any condition that, in the opinion of the Investigator, would interfere with evaluation of BDC-1001 or interpretation of the patient’s safety or study results.
- Cardiovascular exclusions: a. Has a medical history of symptomatic congestive heart failure (New York Heart Association classes II-IV) or a cardiac arrhythmia that requires treatment. b. Has a medical history of myocardial infarction or unstable angina within 6 months before C1D1. c. Has a mean QT corrected—Fridericia’s formula (QTcF) prolongation of > 450 milliseconds (ms) in males and > 470 ms in females based on a 12-lead electrocardiogram (ECG) in triplicate. d. Has a medical history of an arterial thrombotic event, stroke, or transient ischemia attack within the past 12 months.
See the full eligibility criteria
Who can join
- For Part 1 and Part 2: a. Patient has an advanced solid tumor for which approved therapies have been exhausted or for which the Investigator considers the patient ineligible or intolerant of other forms of treatment b. Tumor has documented HER2 expression (including both HER2-low and HER2+). At least 1 of the first 3 patients evaluated for DLT in Cohort M2 and all subsequent cohorts in Part 1 requires documented HER2 protein expression (IHC2+ or IHC3+) in tumor tissue.
- Willing and able to provide blood samples prior to the start of this study
- At least 4 weeks post-op from prior major surgery
- Laboratory values at Screening must be according to protocol.
- Women of childbearing potential should use a ‘highly effective contraceptive measure’ (a method that can achieve a failure rate of less than 1% per year) during treatment and until 7 months after the end of treatment
- Potent men who are partners of women of childbearing potential must be willing to use condoms in combination with a second highly effective method (as above) of female contraception during the study and until 7 months after the end of treatment. A male partner will be considered as potent unless surgically sterilized (with appropriate documentation of sterility).
- For Part 3 and Part 4: a. Patient has an advanced HER2-positive solid tumor (defined as IHC 3+ or HER2 gene amplification) for which approved therapies have been exhausted or for which the Investigator considers the patient ineligible or intolerant of other forms of treatment and also has some conditions.
- Age greater than or equal to 18 years old
- Mentally competent and able to understand and sign the informed consent form
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Expected life expectancy of greater than 12 weeks per the Investigator
- Has LVEF ≥ 50% by either echocardiography or multiple-gated acquisition within 28 days before C1D1
- Has disease that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Parts 1 and 2: Able to provide archival formalin-fixed paraffin-embedded (FFPE) tumor tissue block and consent to collection of screening tumor biopsy for exploratory biomarker evaluation. If an archival block is unavailable, at least 15 freshly sectioned unstained slides may be submitted. Parts 3 and 4: Pre-treatment tumor tissue biopsy should be conducted, and fresh tissue submitted. If a fresh biopsy is not safely accessible or clinically feasible, an archival tumor tissue specimen must be submitted.
What rules you out
- Exclusion Criteria (Section 4.2): 1. For Part 2 and Part 4 with BDC-1001 and nivolumab combination therapy: a. Patient has a history of immune-mediated colitis. b. Patient has an active autoimmune disease with the exception of auto-immune endocrinopathies that are stable on hormone replacement therapy. c. History of allergy or hypersensitivity to nivolumab components. d. History of life-threatening toxicity related to prior immune therapy (eg, anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) or anti-programmed death 1 (PD-1)/programmed death ligand 1 (PD-L1) (PD-1/ PD-L1) treatment or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) except those that are unlikely to re-occur with standard countermeasures (eg, Hypothyroidism).
- Patient has had an organ transplantation.
- Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to C1D1 (ie, participants with a history of prior malignancy are eligible if treatment was completed at least 2 years before C1D1 and the patient has no evidence of disease). Participants with history of prior early stage basal/squamous cell skin cancer or non-invasive or in situ cancers that have undergone definitive treatment at any time are also eligible.
- Patient has an active, known, or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- Any condition that, in the opinion of the Investigator, would interfere with evaluation of BDC-1001 or interpretation of the patient’s safety or study results.
- Cardiovascular exclusions: a. Has a medical history of symptomatic congestive heart failure (New York Heart Association classes II-IV) or a cardiac arrhythmia that requires treatment. b. Has a medical history of myocardial infarction or unstable angina within 6 months before C1D1. c. Has a mean QT corrected—Fridericia’s formula (QTcF) prolongation of > 450 milliseconds (ms) in males and > 470 ms in females based on a 12-lead electrocardiogram (ECG) in triplicate. d. Has a medical history of an arterial thrombotic event, stroke, or transient ischemia attack within the past 12 months.
- Other exclusions according to protocol.
- Patient has known human immunodeficiency virus (HIV) infection (by antibody test), active hepatitis B infection (by hepatitis B surface antigen [HbsAg] test), or hepatitis C infection (by antibody test followed by confirmatory RNA test if antibody test is positive).
- Patient is unwilling to use highly-effective contraceptive methods (as per Inclusion Section 4.1).
- Patient has untreated central nervous system or brain metastases except for disease that is asymptomatic, clinically stable, and has not required steroids for at least 14 days prior to C1D1.
- Patient taking steroids exceeding 10 mg/day prednisone or equivalent dose. Inhaled, intranasal, intraocular, topical, and intraarticular joint injections of corticosteroids are allowed
- Patient has a serious illness considered by the Investigator as incompatible with participating in the protocol.
- Patient is unwilling or unable to follow protocol requirements.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Korea, Democratic People's Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Korea, Democratic People's Republic of. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.