BridgeMD
A study to test whether different doses of BI 764532 help people with small cell lung cancer or other neuroendocrine cancers
EU CTIS ID: 2023-504247-13-00
What this study is testing
This trial will have three parts: a dose selection part (Part 1), an epNEC expansion cohorts (Parts 2) and an epNEC expansion cohort with reduced monitoring (Part 3). Part 1, Dose selection part objectives The primary objective of the dose selection part (Part 1) is to evaluate safety and efficacy of two dose levels of BI 764532 monotherapy in patients with SCLC who have had progression or recurrence following after at least two prior lines of therapy, including at least one platinum-based regimen, and in patients with histologically or cytologically confirmed advanced or metastatic epNEC (excluding MCC, MTC and NEPC) or LCNEC of the lung as defined by the 2022 WHO classification of Neuroendocrine Neoplasms who have had progression or recurrence following at least one platinum-based regimen. Part 2, epNEC Expansion cohort objectives The epNEC expansion cohort will assess the efficacy and safety of BI 764532 monotherapy in patients with histologically or cytologically confirmed advanced or metastatic epNEC, and DLL3 high expression who have progression or recurrence following at least one platinum-based regimen. The primary objective is to assess the anti-tumour activity of BI 764532 at the selected dose in DLL3 high expression epNEC patients where the primary measure of interest is the proportion of patients with objective response according to RECIST v 1.1 as assessed by blinded independent central review. Intercurrent event handling for the primary analysis of OR will be using a combined while-on-treatment and treatment policy strategy. Part 3, epNEC Expansion cohort, reduced monitoring, objectives The epNEC expansion cohort in Part 3 will assess the safety and efficacy of BI 764532 monotherapy at the selected dose with outpatient monitoring setting in patients with histologically or cytologically confirmed advanced or metastatic epNEC, and DLL3 high expression who have progression or recurrence following at least one platinum-based regimen. The primary objective of Part 3 is to evaluate the safety (by incidence of treatment-emergent adverse events) and the efficacy (by proportion of patients with objective response (OR) by blinded independent central review) of BI 764532 at the selected dose with outpatient monitoring setting in DLL3 high expressing tumours.
- Therapeutic exploratory (Phase II)
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
- Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the informed consent form (ICF).
- Only for Part 3, at the timepoint of Screening 02: - For Cycle 1, patients should be willing to stay within 1 hour driving distance for 48 hours after IMP administration and confirm availability of a caregiver for the same timeframe. - Patients should be considered suitable by the investigator to follow instructions applicable to the reduced monitoring cohort, such as taking their temperature and administration of oral medication at home if needed.
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
- Part 1: Histologically or cytologically confirmed, cancer of the following histologies: a. SCLC b. epNEC (except MCC, MTC and NEPC) c. LCNEC of the lung Patients with tumours with mixed histologies for any above type are eligible only if the neuroendocrine carcinoma/small tumour cells component is predominant and represents at least 50% of the overall tumour tissue. Patients must have progressed or recurred after standard of care therapy a. SCLC: after at least two prior lines of therapy, including at least one platinum-based regimen b. Therapy includes PD-L1 inhibitor treatment; patients should have received the combination of platinum-based regimen plus PD-L1 inhibitor unless they have been unable to receive checkpoint inhibitor treatment. c. epNEC/LCNEC: after at least one platinum-based regimen. Part 2 and part 3: Histologically or cytologically confirmed epNEC (except MCC, MTC and NEPC) with centrally assessed DLL3 high expression status. Patients must have progressed or recurred after at least one platinum-based regimen.
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Measurable lesions as defined per RECIST v 1.1 within 21 days prior to the first dose of BI 764532.
You likely can't join if
- 1. Untreated or symptomatic brain metastases (Part 2 and part 3: identified during the mandatory assessment by brain MRI within 21 days before first trial drug administration.) Participants with treated, stable brain metastases are eligible provided they meet the following criteria: - Radiotherapy or surgery for brain metastases was completed at least 2 weeks prior to the first administration of BI 764532. - Patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the patient is off anti-epileptic drugs for at least 7 days or on stable doses of anti-epileptic drugs for malignant CNS disease
- 7. Diagnosis of immunodeficiency or systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of BI 764532. Physiological replacement of steroids is allowed.
- 8. Unresolved toxicity from prior anti-tumour therapy, defined in the inclusion criteria.
- 9. Further exclusion criteria apply.
- 2. Presence of leptomeningeal disease or, part 2 and part 3: epidural disease including spinal cord compression.
- 3. Part 1: Active/previous history of interstitial lung disease or non-infectious pneumonitis (any grade). Part 2: Active/previous history of interstitial lung disease, pulmonary fibrosis, organizing pneumonia or non-infectious pneumonitis (any grade). Patients with a history of therapy-related pneumonitis that is considered clinically resolved are eligible.
See the full eligibility criteria
- Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the informed consent form (ICF).
- Only for Part 3, at the timepoint of Screening 02: - For Cycle 1, patients should be willing to stay within 1 hour driving distance for 48 hours after IMP administration and confirm availability of a caregiver for the same timeframe. - Patients should be considered suitable by the investigator to follow instructions applicable to the reduced monitoring cohort, such as taking their temperature and administration of oral medication at home if needed.
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
- Part 1: Histologically or cytologically confirmed, cancer of the following histologies: a. SCLC b. epNEC (except MCC, MTC and NEPC) c. LCNEC of the lung Patients with tumours with mixed histologies for any above type are eligible only if the neuroendocrine carcinoma/small tumour cells component is predominant and represents at least 50% of the overall tumour tissue. Patients must have progressed or recurred after standard of care therapy a. SCLC: after at least two prior lines of therapy, including at least one platinum-based regimen b. Therapy includes PD-L1 inhibitor treatment; patients should have received the combination of platinum-based regimen plus PD-L1 inhibitor unless they have been unable to receive checkpoint inhibitor treatment. c. epNEC/LCNEC: after at least one platinum-based regimen. Part 2 and part 3: Histologically or cytologically confirmed epNEC (except MCC, MTC and NEPC) with centrally assessed DLL3 high expression status. Patients must have progressed or recurred after at least one platinum-based regimen.
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Measurable lesions as defined per RECIST v 1.1 within 21 days prior to the first dose of BI 764532.
- Part 1: Availability of archival tumour tissue sample Part 2 and part 3: Availability of archival formalin-fixed paraffin-embedded (FFPE) tumour tissue sample. Following specimens are not allowed: Fine Needle Aspiration (FNA), Cytology samples, decalcified bone samples.
- Adequate organ function as defined in the protocol.
- All toxicities related to previous anti-cancer therapies have resolved ≤ CTCAE Grade 1 prior to trial treatment administration (except for alopecia, peripheral neuropathy , fatigue and endocrinopathies controlled by replacement therapy which must be ≤ CTCAE Grade 2 and amenorrhea/menstrual disorders which can be any grade).
- Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use acceptable methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in the participant information and in the protocol.
- 1. Untreated or symptomatic brain metastases (Part 2 and part 3: identified during the mandatory assessment by brain MRI within 21 days before first trial drug administration.) Participants with treated, stable brain metastases are eligible provided they meet the following criteria: - Radiotherapy or surgery for brain metastases was completed at least 2 weeks prior to the first administration of BI 764532. - Patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the patient is off anti-epileptic drugs for at least 7 days or on stable doses of anti-epileptic drugs for malignant CNS disease
- 7. Diagnosis of immunodeficiency or systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of BI 764532. Physiological replacement of steroids is allowed.
- 8. Unresolved toxicity from prior anti-tumour therapy, defined in the inclusion criteria.
- 9. Further exclusion criteria apply.
- 2. Presence of leptomeningeal disease or, part 2 and part 3: epidural disease including spinal cord compression.
- 3. Part 1: Active/previous history of interstitial lung disease or non-infectious pneumonitis (any grade). Part 2: Active/previous history of interstitial lung disease, pulmonary fibrosis, organizing pneumonia or non-infectious pneumonitis (any grade). Patients with a history of therapy-related pneumonitis that is considered clinically resolved are eligible.
- 4. Participants who experienced severe, life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents.
- 5. Prior anti-cancer therapy: • Patients who have been treated with any other anti-cancer drug within 4 weeks or within 5 half-life periods (whichever is shorter) prior to first administration of BI 764532. • Patients who have been treated with extensive field radiotherapy including whole brain irradiation within 2 weeks prior to first administration of BI 764532.
- 6. Previous treatment with DLL3-targeting T cell engagers or cell therapies.
The study team makes the final eligibility decision.
Where it's taking place
- Taiwan
- Japan
- United Kingdom
- United States
- Korea, Republic of
- China
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taiwan; Japan; United Kingdom; United States; Korea, Republic of; China. 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.