Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0KDAUC
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| ADC Name |
Trastuzumab imbotolimod
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| Synonyms |
BDC-1001; trastuzumab imbotolimod
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| Organization |
Bolt Biotherapeutics (Originator)
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| Drug Status |
Phase 2 (discontinued)
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| Structure |
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| Antibody Name |
Trastuzumab
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Antibody Info | ||||
| Antigen Name |
Receptor tyrosine-protein kinase erbB-2 (HER2 ECD2); Receptor tyrosine-protein kinase erbB-2 (HER2 ECD4)
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Antigen Info | ||||
| Payload Name |
T785
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Payload Info | ||||
| Therapeutic Target |
Toll-like receptor 7 (TLR7); Toll-like receptor 8 (TLR8)
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Target Info | ||||
| Linker Name |
BG based linker
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Linker Info | ||||
| Conjugate Type |
Random Lysines
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| Combination Type |
imbotolimod
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The indication landscape of This ADC(2027 Update)
The clinical trial pipeline of This ADC(2027 Update)
| Indication | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | New Drug Application | Approved | ||||
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| Breast cancer |
1 Trials
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1 Trials
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| Colorectal cancer |
1 Trials
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| Endometrial cancer |
1 Trials
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| Gastroesophageal junction adenocarcinoma |
1 Trials
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| Unspecific solid tumor |
1 Trials
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General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Partial Response (PR) |
27%
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| Patients Enrolled |
Eligible patients must have HER2-positive advanced solid tumors with exhausted treatment options, measurable disease (RECIST 1.1), ECOG 0-1, and available tumor tissue. Exclusions include hypersensitivity to study drugs, prior TLR7/8 agonist treatment, cardiac dysfunction, active infections (HIV, HBV, HCV, SARS-CoV-2), and untreated CNS metastases. Other protocol-specific criteria may apply.
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| Administration Dosage |
Pts with HER2+ (protein or gene) or HER2-low solid tumors progressing after standard therapies (Txs) were enrolled. BDC-1001 was given IV q3w, q2w, or q1w as monotherapy (mono; n=94) and q2w or q1w with nivolumab 240mg q2w (combo; n=37).
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| Related Clinical Trial | |||||
| NCT Number | NCT04278144 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description | Phase 1/2 Study of BDC-1001 As a Single Agent and in Combination with Nivolumab in Patients with Advanced HER2-Expressing Solid Tumors | ||||
| Primary Endpoint |
The study evaluates safety (AEs, SAEs, DLTs, and immune-related toxicities) and determines the maximum tolerated dose (MTD) during the escalation phase, alongside assessing ORR of complete/partial responses (CR/PR) in the expansion phase over a 2-year timeframe.
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| Other Endpoint |
Pharmacokinetic parameters (Cmax, Cmin, AUC, CL, Vz, t1/2) of BDC-1001 are measured during both escalation and expansion periods, alongside efficacy outcomes (ORR, DOR, DCR, PFS per RECIST 1.1) and immunogenicity (anti-BDC-1001 antibodies) over 2 years.
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Eligible participants must have confirmed HER2+ breast adenocarcinoma (IHC 3+/ISH+/NGS+) with ≥2 prior anti-HER2 therapies (including trastuzumab deruxtecan), measurable disease, ECOG 0-1, and biopsy/archival tissue. Key exclusions cover hypersensitivity to BDC-1001/pertuzumab, prior TLR7/8 agonist treatment, significant cardiac disease, active viral infections, and unstable CNS metastases.
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| Administration Dosage |
BDC-1001 administered intravenously (IV) every 2 weeks
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| Related Clinical Trial | |||||
| NCT Number | NCT05954143 | Clinical Status | PHASE2 | ||
| Clinical Description | Phase 2, Multi-Center, Randomized, Open-Label Trial of BDC-1001 As a Single Agent and in Combination with Pertuzumab in Subjects with HER2-Positive Metastatic Breast Cancer Previously Treated with Trastuzumab Deruxtecan | ||||
| Primary Endpoint |
The efficacy of BDC-1001 alone and combined with pertuzumab is evaluated through Objective Response Rate (ORR) per RECIST v1.1 at 12 weeks.
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| Other Endpoint |
Additional endpoints include long-term efficacy (DOR, DCR, PFS, OS up to 24 months), safety (TEAEs/TESAEs), pharmacokinetics (Cmin, Cmax), and immunogenicity (anti-BDC-1001 ADAs) during the 24-month period for both single-agent and combination therapy.
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| Experiment 3 Reporting the Activity Date of This ADC | [3] | ||||
| Patients Enrolled |
Patients with advanced metastatic HER2-expressing (IHC2/3+) or amplified solid tumors. Patients had received a median of 4 prior therapies.
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| Administration Dosage |
4 dose levels (0.15-5.00 mg/kg) every 3 weeks.
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| Related Clinical Trial | |||||
| NCT Number | NCT04278144 | Clinical Status | Phase 1/2 | ||
| Clinical Description | Phase 1/2 study of BDC-1001 as a single agent and in combination with nivolumab in patients with advanced HER2-expressing solid tumors. | ||||
References