Antibody Information
General Information of This Antibody (ID: ANTI0YZPYM)
| Antibody Name | Anti-B7H3 antibody |
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| Antigen Name | B7-H3 |
Antigen Info | ||||
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Each Antibody-drug Conjugate Related to This Antibody
Full Information of The Activity Data of The ADC(s) Related to This Antibody
DB-1311 [Phase 3]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
28.6
45.5 % |
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| Patients Enrolled |
Eligible adults (≥18) have advanced solid tumors (measurable per RECIST 1.1/RANO 2.0), ECOG 0-1, LVEF ≥50%, and adequate organ function. Exclusions: prior B7-H3/TOP1-ADC therapy, uncontrolled cardiac/pulmonary conditions (e.g., CHF, ILD), active infections (HBV/HCV exceptions), untreated CNS metastases, or unresolved Grade ≥2 toxicity. Contraception is mandatory (7 months for females, 4 for males). Cohort-specific criteria apply (e.g., SCLC: prior platinum therapy; CRPC: progression per PCWG3).
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| Related Clinical Trial | |||||
| NCT Number | NCT05914116 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description |
A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1311 in Subjects With Advanced/Metastatic Solid Tumors
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| Primary Endpoint |
The Phase 1 study assesses DLTs (first 21 days), MTD/RP2D determination (over 12 months), and safety profile (TEAEs/SAEs per CTCAE v5.0 over ~1 year). Phase 2a evaluates ORR by RECIST 1.1 (non-CRPC/non-GBM), PCWG3 (CRPC bone metastases), or RANO 2.0 (GBM), alongside continued safety monitoring.
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| Other Endpoint |
Key secondary endpoints include ORR, DOR, DCR, TTR, PFS, OS (tracked for ~1 year), and PSA dynamics in CRPC. PK parameters (AUC, Cmax, Tmax, Ctrough) are analyzed over 8 cycles (21 days/cycle), alongside ADA prevalence/incidence. Tumor response criteria vary by cohort (RECIST 1.1, PCWG3, RANO 2.0).
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ILB-3101 [Phase 1/2]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Key inclusion: aged 18-80; ECOG 0-1; life expectancy >12 weeks; histologically confirmed advanced/metastatic solid tumors refractory to standard therapy; measurable lesion (s); adequate organ function; negative pregnancy test; effective contraception.
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| Administration Dosage |
There are eight escalating dose cohorts. Intravenous (IV) administration of ILB-3101 Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.
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| Related Clinical Trial | |||||
| NCT Number | NCT06426680 | Clinical Status | PHASE1 | ||
| Clinical Description |
Phase I/II Study of the ILB-3101 in Patients with Advanced Solid Tumors
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| Primary Endpoint |
Primary endpoints include DLT assessment (Day 21), MTD determination (Day 21) for ILB-3101 in advanced solid tumors.
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| Other Endpoint |
Secondary endpoints comprise ORR (RECIST 1.1, 24 months), AE incidence (CTCAE v5.0, 90 days post-treatment), ADA development (90 days post-treatment), PK parameters (Cmax/Tmax/T1/2/AUC0-t, Cycle 1), and efficacy measures (DOR/DCR/PFS per RECIST 1.1, 24 months).
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MHB088C [Phase 3]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [3] | ||||
| Patients Enrolled |
Eligible participants (≥18 years, ECOG 0-1) must have advanced/metastatic solid tumors (NSCLC, SCLC, ESCC, CRPC, MEL, CRC, PDAC, HNSCC, HCC, OC, EC, TC, or SARC) refractory to standard therapies, measurable lesions per RECIST v1.1 (or PCWG3 for CRPC), and adequate organ function. Exclusions: active infections (HBV/HCV/HIV, COVID-19), uncontrolled cardiovascular/neurological conditions, recent major surgery/immunosuppressants, brain metastases (unless stable ≥1 month), prior MHB088C-targeted therapy, pregnancy/breastfeeding, or investigator-assessed ineligibility. Contraception is mandated during and for 90 days post-treatment.
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| Administration Dosage |
MHB088C will be administered intravenously at a frequency of once every 2 weeks (Q2W).
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| Related Clinical Trial | |||||
| NCT Number | NCT05652855 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description |
Phase 1/2, Two-Part, Multi-center, Open-label, Dose Escalation and Dose Expansion First-In-Human Study to Evaluate the Safety/Tolerability, Pharmacokinetics and Efficacy of MHB088C in Participants With Advanced or Metastatic Solid Tumors
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| Primary Endpoint |
This clinical trial assesses safety by monitoring adverse events (AEs) per NCI-CTCAE v5.0 and dose-limiting toxicities (DLTs) over one year to establish the maximum tolerated dose (MTD) and recommend a Phase 2 dose (RP2D) of MHB088C. Efficacy is measured via objective response rate (ORR) based on RECIST v1.1 criteria for complete (CR) or partial response (PR).
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| Other Endpoint |
Pharmacokinetic parameters-such as Cmax, Tmax, AUC, Ctrough, t1/2, and systemic clearance (CL)-are evaluated for MHB088C, total antibody, and free toxin MH30010008 over five 28-day cycles. Immunogenicity is assessed via anti-drug antibody (ADA) testing, while efficacy outcomes include duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), and RECIST v1.1-defined tumor progression over one year.
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BAT8009 [Phase 1 (discontinued)]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [4] | ||||
| Patients Enrolled |
Eligible participants must be 18-75 years old with advanced/metastatic solid tumors refractory to standard therapy, adequate organ function, and measurable disease per RECIST v1.1, while exclusions involve pregnancy, active CNS metastases, recent major surgery, severe infections, HIV/hepatitis B/C, or prior Grade 3-4 antibody therapy reactions, ensuring patient safety and protocol adherence.
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| Administration Dosage |
BAT8009 will be administered as a 90-minute (± 5min) IV infusion on Day 1 of Cycle 1. If there is no infusion related reaction after initial dose, the next dose of BAT8009 will be infused intravenously into each patient for approximately 30~120 minutes.
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| Related Clinical Trial | |||||
| NCT Number | NCT05405621 | Clinical Status | PHASE1 | ||
| Clinical Description |
A Phase 1, Multi-Center, Open-Label Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT8009 in Patients With Advanced Solid Tumours
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| Primary Endpoint |
The primary endpoint assesses dose-limiting toxicity (DLT) occurring within 21 days post-initial BAT8009 administration, defining toxicity parameters during the observation period to evaluate safety tolerability.
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| Other Endpoint |
Secondary endpoints include pharmacokinetic measures like Cmax (maximum serum concentration) and AUC0-inf/AUC0-λ over 126 days, alongside immunogenicity monitoring for anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs) to characterize drug exposure and immune response profiles.
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| Experiment 2 Reporting the Activity Date of This ADC | [5] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT05405621 | Clinical Status | Phase 1 | ||
| Clinical Description |
A phase 1, multi-center, open-label study to assess safety, tolerability, pharmacokinetics, and preliminary efficacy of BAT8009 in patients with advanced solid tumours.
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References