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Sponsor Decision
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| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
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This is an open-label, Phase 2 study to evaluate preliminary anti-tumor activity, safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of BDC-1001 administered as a single agent and in combination with pertuzumab in subjects with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (MBC) previously treated with trastuzumab deruxtecan (Enhertu®).
Eligible subjects will be randomly assigned in a 1:1 ratio to receive BDC-1001 as a single agent or BDC-1001 in combination with pertuzumab. Within each treatment arm, a Simon 2-stage design will be applied. Subjects will receive study treatment (i.e., BDC-1001 or BDC-1001 in combination with pertuzumab) for up to 24 months after Cycle 1 Day 1 (C1D1), until disease progression, unacceptable toxicity, or withdrawal for any reason.
Bolt amended the protocol to transition any subjects still receiving BDC-1001 to continue receiving BDC-1001 in the Maintenance Phase. Subjects remaining on BDC-1001 will continue to receive BDC-1001 until a criterion for discontinuation has been met.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BDC-1001 Single Agent | Experimental | BDC-1001 administered intravenously (IV) every 2 weeks |
|
| BDC-1001 in Combination With Pertuzumab | Experimental | BDC-1001 administered intravenously (IV) every 2 weeks, in combination with pertuzumab administered intravenously (IV) as a fixed non-weight-based dose of 840-mg IV loading dose and then 420-mg IV maintenance dose every 3 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BDC-1001 | Drug | BDC-1001 is an immune-stimulating antibody conjugate (ISAC) designed to be delivered systemically (intravenously) and act locally by targeting HER2-expressing tumors and related metastatic disease for destruction by the innate and adaptive immune systems. BDC-1001 consists of an investigational biosimilar of the humanized monoclonal antibody (mAb) trastuzumab that is chemically conjugated to a toll-like receptor (TLR)7/8 agonist (payload) with an intervening non-cleavable, cell membrane impermeable linker. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) Per RECIST v1.1 as Assessed by Investigator | Objective Response Rate (ORR) was defined as the proportion of participants with best overall response of confirmed Complete Response (CR) or Partial Response (PR) as determined by the treating Investigator using RECIST v1.1 criteria. | Up to approximately 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) Per RECIST v1.1 as Assessed by Investigator | Duration of Response (DOR) was calculated for participants who achieved confirmed CR or PR. For such participants, DOR is defined as the duration from the start date of CR or PR (whichever response status is observed first) and subsequently confirmed, to the earliest of documented date of PD per RECIST v 1.1 or death. Of the 8 participants with response assessments, there were no participants with PR or CR. Because there were no responses of PR or CR, the DOR cannot be calculated. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bolt Clinical Development | Bolt Biotherapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Irvine | California | 92618 | United States | ||
| Memorial Sloan Kettering Cancer Center |
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Participants were enrolled at study sites in the United States and Spain.
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| ID | Title | Description |
|---|---|---|
| FG000 | BDC-1001 Single Agent | Participants received BDC-1001 administered intravenously (IV) every 2 weeks |
| FG001 | BDC-1001 in Combination With Pertuzumab | Participants received BDC-1001 administered intravenously (IV) every 2 weeks, in combination with pertuzumab administered intravenously (IV) as a fixed non-weight-based dose of 840-mg IV loading dose and then 420-mg IV maintenance dose every 3 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BDC-1001 Single Agent | Participants received BDC-1001 administered intravenously (IV) every 2 weeks |
| BG001 | BDC-1001 in Combination With Pertuzumab | Participants received BDC-1001 administered intravenously (IV) every 2 weeks, in combination with pertuzumab administered intravenously (IV) as a fixed non-weight-based dose of 840-mg IV loading dose and then 420-mg IV maintenance dose every 3 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Response Rate (ORR) Per RECIST v1.1 as Assessed by Investigator | Objective Response Rate (ORR) was defined as the proportion of participants with best overall response of confirmed Complete Response (CR) or Partial Response (PR) as determined by the treating Investigator using RECIST v1.1 criteria. | Three of the 11 participants did not have response assessments. | Posted | Count of Participants | Participants | Up to approximately 1 year |
|
From first dose of study treatment up through Safety Follow-Up (up to 35 days after last dose of study treatment). This period was up to approximately 1 year.
The safety population included the participants who received at least one dose of study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BDC-1001 Single Agent | Participants received BDC-1001 administered intravenously (IV) every 2 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 27 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Development Operations | Bolt Biotherapeutics, Inc. | 1-650-434-8640 | clinicaltrials@boltbio.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 1, 2024 | Aug 13, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 14, 2024 | Aug 13, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C485206 | pertuzumab |
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|
| Pertuzumab | Drug | Pertuzumab is a monoclonal antibody that targets HER2 and prevents dimerization of HER2 with other members of the HER family (HER1, HER3, and HER4), thereby blocking ligand-activated downstream signaling. |
|
|
| Up to approximately 1 year |
| Disease Control Rate (DCR) Per RECIST v1.1 as Assessed by Investigator | Disease Control Rate (DCR) was the proportion of participants who achieved confirmed Complete Response (CR), Partial Response (PR), or Stable Disease (SD) lasting 23 or more weeks following the first dose of study treatment. | Up to approximately 1 year |
| Progression-Free Survival (PFS) Per RECIST 1.1 as Assessed by Investigator | Progression-free survival (PFS) was defined as the duration from the date of first study treatment administration (Cycle 1 Day 1) to the earliest date of documented PD per RECIST v1.1 or death. A death was considered a PFS event. | Up to approximately 1 year |
| Overall Survival (OS) | Overall Survival (OS) was defined as the duration from the date of first study treatment administration to the date of death, irrespective of cause. | Up to approximately 1 year |
| Number of Participants With at Least 1 Treatment Emergent Adverse Event (TEAE) | Treatment Emergent Adverse Events (TEAE) was defined as any AE that started on or after the first administration of study treatment. TEAEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. | Continuously from first dose of study treatment through end of treatment and Safety Follow-Up. Up to approximately 1 year |
| Number of Participants Who Had Any Treatment Emergent Adverse Event (TEAE) Related to Study Treatment | Treatment Emergent Adverse Events (TEAE) was defined as any AE that started on or after the first administration of study treatment. TEAEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. | Continuously from first dose of study treatment through end of treatment and Safety Follow-Up. Up to approximately 1 year. |
| Number of Participants With Any Treatment Emergent Serious Adverse Event (SAE) Related to Study Treatment | Treatment Emergent Adverse Events (TEAE) was defined as any AE that started on or after the first administration of study treatment. TEAEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. A Serious Adverse Event (SAE) was defined as an AE event that resulted in death, was life-threatening, required or prolongs hospitalization, caused persistent or significant disability or incapacity, resulted in congenital anomalies or birth defects, or was an important medical event. | Continuously from first dose of study treatment through end of treatment and Safety Follow-Up. Up to approximately 1 year. |
| New York |
| New York |
| 10065 |
| United States |
| Virginia Cancer Specialists | Arlington | Virginia | 22205 | United States |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Study Terminated by Sponsor |
|
| Death |
|
| Withdrawal by Subject |
|
| Other |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
|
|
| Secondary | Duration of Response (DOR) Per RECIST v1.1 as Assessed by Investigator | Duration of Response (DOR) was calculated for participants who achieved confirmed CR or PR. For such participants, DOR is defined as the duration from the start date of CR or PR (whichever response status is observed first) and subsequently confirmed, to the earliest of documented date of PD per RECIST v 1.1 or death. Of the 8 participants with response assessments, there were no participants with PR or CR. Because there were no responses of PR or CR, the DOR cannot be calculated. | DOR was not assessed as there were no participants with CR or PR. | Posted | Count of Participants | Participants | Up to approximately 1 year |
|
|
|
| Secondary | Disease Control Rate (DCR) Per RECIST v1.1 as Assessed by Investigator | Disease Control Rate (DCR) was the proportion of participants who achieved confirmed Complete Response (CR), Partial Response (PR), or Stable Disease (SD) lasting 23 or more weeks following the first dose of study treatment. | Posted | Count of Participants | Participants | Up to approximately 1 year |
|
|
|
| Secondary | Progression-Free Survival (PFS) Per RECIST 1.1 as Assessed by Investigator | Progression-free survival (PFS) was defined as the duration from the date of first study treatment administration (Cycle 1 Day 1) to the earliest date of documented PD per RECIST v1.1 or death. A death was considered a PFS event. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 1 year |
|
|
|
| Secondary | Overall Survival (OS) | Overall Survival (OS) was defined as the duration from the date of first study treatment administration to the date of death, irrespective of cause. | All treated participants are included | Posted | Number | Participants | Up to approximately 1 year |
|
|
|
| Secondary | Number of Participants With at Least 1 Treatment Emergent Adverse Event (TEAE) | Treatment Emergent Adverse Events (TEAE) was defined as any AE that started on or after the first administration of study treatment. TEAEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. | Posted | Count of Participants | Participants | Continuously from first dose of study treatment through end of treatment and Safety Follow-Up. Up to approximately 1 year |
|
|
|
| Secondary | Number of Participants Who Had Any Treatment Emergent Adverse Event (TEAE) Related to Study Treatment | Treatment Emergent Adverse Events (TEAE) was defined as any AE that started on or after the first administration of study treatment. TEAEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. | Posted | Count of Participants | Participants | Continuously from first dose of study treatment through end of treatment and Safety Follow-Up. Up to approximately 1 year. |
|
|
|
| Secondary | Number of Participants With Any Treatment Emergent Serious Adverse Event (SAE) Related to Study Treatment | Treatment Emergent Adverse Events (TEAE) was defined as any AE that started on or after the first administration of study treatment. TEAEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. A Serious Adverse Event (SAE) was defined as an AE event that resulted in death, was life-threatening, required or prolongs hospitalization, caused persistent or significant disability or incapacity, resulted in congenital anomalies or birth defects, or was an important medical event. | Posted | Count of Participants | Participants | Continuously from first dose of study treatment through end of treatment and Safety Follow-Up. Up to approximately 1 year. |
|
|
|
| 2 |
| 6 |
| 2 |
| 6 |
| 6 |
| 6 |
| EG001 | BDC-1001 in Combination With Pertuzumab | Participants received BDC-1001 administered intravenously (IV) every 2 weeks, in combination with pertuzumab administered intravenously (IV) as a fixed non-weight-based dose of 840-mg IV loading dose and then 420-mg IV maintenance dose every 3 weeks. | 0 | 5 | 2 | 5 | 5 | 5 |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 27 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 27 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Aphasia | Nervous system disorders | MedDRA 27 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 27.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Gastrointestinal sounds abnormal | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Arthritis infective | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Tracheal obstruction | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
|
| Alanine aminotransferase | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Aspartate aminotransferase | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Blood lactate dehydrogenase | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
|
| Nipple exudate bloody | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Cyanosis | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |