Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0DDTZB
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| ADC Name |
HLX43
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| Synonyms |
HLX43; HLXD43; YL222
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| Organization |
Shanghai Henlius Biotech (Originator);MediLink Therapeutics
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| Drug Status |
Phase 2/3
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| Drug-to-Antibody Ratio |
8
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| Structure |
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| Antibody Name |
HLX20
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Antibody Info | ||||
| Antigen Name |
Myeloid cell surface antigen CD33 (CD33); Programmed cell death 1 ligand 1 (CD274)
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Antigen Info | ||||
| Payload Name |
YL0010014
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Payload Info | ||||
| Therapeutic Target |
DNA topoisomerase 1 (TOP1)
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Target Info | ||||
| Linker Name |
VK*G-NHCH2-O linker
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Linker Info | ||||
| Conjugate Type |
Random Cysteines
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| Combination Type |
pelitecan
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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 |
2 Trials
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| Cervical cancer |
1 Trials
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| Colorectal cancer |
1 Trials
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| Gastric cancer |
1 Trials
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| Gastroesophageal junction adenocarcinoma |
1 Trials
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| Head and neck cancer |
1 Trials
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| Liver cancer |
1 Trials
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| Lung cancer |
1 Trials
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1 Trials
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1 Trials
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| Nasopharyngeal cancer |
1 Trials
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| Oesophageal cancer |
1 Trials
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| Ovarian cancer |
1 Trials
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| Pancreatic cancer |
1 Trials
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| Thymus cancer |
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] | ||||
| Patients Enrolled |
Key exclusions were active CNS metastases, uncontrolled effusions, grade ≥1 radiation pneumonitis, autoimmune/immunosuppressive conditions, recent live vaccines, HIV/HBV/HCV infection, or pregnancy. Contraception was required for 6 months post-treatment.
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| Administration Dosage |
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| Related Clinical Trial | |||||
| NCT Number | NCT06769152 | Clinical Status | PHASE2 | ||
| Clinical Description | A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients with Recurrent/Metastatic Cervical Cancer (CC) Failed or Intolerance to Standard First-Line Therapy | ||||
| Primary Endpoint |
The study evaluated cervical cancer patients (18-75 years) with disease progression after ≥1 prior systemic therapy, measurable lesions per RECIST v1.1, ECOG 0-1, and adequate organ function.
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| Other Endpoint |
Primary endpoints included ORR (investigator/IRRC-assessed) and PFS per RECIST v1.1 at 24 weeks, with secondary endpoints of OS (up to 36 months) and AE incidence/severity (CTCAE v5.0) over 24 months.
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Eligible patients (18-75 years, ECOG 0-1) had advanced ESCC refractory to prior therapy, measurable lesions, and adequate organ function. Key exclusions included BMI <17.5, uncontrolled metastases/effusions, grade ≥3 radiation pneumonitis/ILD, active infections, recent immunosuppressants/CYP modulators, or HIV/HBV/HCV infection. Contraception was required for 6 months post-treatment.
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| Administration Dosage |
Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first)
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| Related Clinical Trial | |||||
| NCT Number | NCT06769113 | Clinical Status | PHASE2 | ||
| Clinical Description | A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients With Recurrent/Metastatic Esophageal Squamous Cell Carcinoma (ESCC) Failed or Intolerance to Standard First-line Therapy | ||||
| Primary Endpoint |
The study evaluated ORR (investigator-assessed) and PFS (time to progression/death) per RECIST v1.1 in ESCC patients over 24 weeks and 14 months respectively.
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| Other Endpoint |
Additional efficacy measures included IRRC-assessed ORR/PFS, OS (up to 36 months), and AE incidence/severity (NCI CTCAE v5.0) monitored for 24 months post-treatment.
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| Experiment 3 Reporting the Activity Date of This ADC | [3] | ||||
| Patients Enrolled |
Key eligibility criteria: ECOG 0-1, measurable lesions, adequate organ function. Major exclusions included candidates for curative local therapy, uncontrolled metastases/effusions, grade ≥3 ILD/radiation pneumonitis, active infections (HIV/HBV/HCV), recent immunosuppressants/CYP modulators, or autoimmune diseases (except controlled endocrine disorders). Contraception was mandatory for 6 months post-treatment.
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| Administration Dosage |
Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), until disease progression and loss of benifit, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first).
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| Related Clinical Trial | |||||
| NCT Number | NCT06839066 | Clinical Status | PHASE2 | ||
| Clinical Description | A Phase II Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Subjects with Recurrent/Metastatic Nasopharyngeal Carcinoma (NPC) Failed or Intolerance to Second-line Therapy | ||||
| Primary Endpoint |
Primary efficacy endpoints included investigator-assessed ORR (24 weeks) and PFS (12 months) per RECIST v1.1 in recurrent/metastatic nasopharyngeal carcinoma patients who failed ≥2 prior therapies (including platinum-based chemo and PD-1/PD-L1 inhibitors).
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| Other Endpoint |
Secondary endpoints comprised IRRC-assessed ORR/PFS, OS (18 months), and AE monitoring (NCI CTCAE v5.0) until 90 days post-treatment. Tumor PD-L1 expression analysis was required from archival/fresh biopsies.
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| Experiment 4 Reporting the Activity Date of This ADC | [4] | ||||
| Patients Enrolled |
Key eligibility criteria: Age 18-75, ECOG 0-1, ≥1 measurable lesion, adequate organ function. Major exclusions included: candidates for radical local therapy, uncontrolled metastases/effusions, grade ≥3 immune-related AEs, active ILD/pneumonitis, cardiovascular comorbidities (NYHA II+ heart failure, uncontrolled hypertension/arrhythmias), recent immunosuppressants/CYP modulators, active infections (HIV/HBV/HCV), or autoimmune diseases. Contraception was required for 6 months post-treatment.
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| Administration Dosage |
Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first)
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| Related Clinical Trial | |||||
| NCT Number | NCT06857279 | Clinical Status | PHASE2 | ||
| Clinical Description | A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Subjects with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) | ||||
| Primary Endpoint |
Primary efficacy endpoints included investigator-assessed ORR (24 weeks) and PFS (14 months) per RECIST v1.1 in recurrent/metastatic head and neck squamous cell carcinoma patients who failed prior systemic treatment.
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| Other Endpoint |
Secondary endpoints comprised IRRC-assessed ORR/PFS, OS (36 months), and comprehensive safety monitoring (NCI CTCAE v5.0) including AEs, vital signs and lab results for 24 months. Tumor tissue analysis was required from archival samples or fresh biopsies.
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| Experiment 5 Reporting the Activity Date of This ADC | [5] | ||||
| Patients Enrolled |
Key eligibility: Child-Pugh A liver function, ECOG 0-1, ≥1 measurable lesion. HBV/HCV virologic control required (HBV-DNA <500 IU/mL; HCV-RNA positive required antiviral therapy). Major exclusions: fibrolamellar/mixed HCC, main portal vein Vp4 invasion, uncontrolled variceal bleeding risk, recent local liver therapy (≤4 weeks), grade ≥3 immune-related AEs, active infections (HIV excluded), or significant cardiovascular comorbidities. Contraception was mandatory for 6 months post-treatment.
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| Administration Dosage |
Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first)
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| Related Clinical Trial | |||||
| NCT Number | NCT06742892 | Clinical Status | PHASE2 | ||
| Clinical Description | A Phase II Clinical Study to Evaluate HLX43 (Anti-PD-L1 ADC) in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) Failed or Intolerance to Standard Therapy | ||||
| Primary Endpoint |
Primary efficacy endpoints included investigator-assessed ORR (24 weeks) and PFS (14 months) per RECIST v1.1 in advanced HCC patients (BCLC stage C or B unsuitable for local therapy) who failed prior systemic treatment (PD-1/L1-based therapy or TKIs).
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| Other Endpoint |
Secondary endpoints comprised IRRC-assessed ORR/PFS, OS (36 months), and comprehensive safety monitoring (NCI CTCAE v5.0) including AEs, vital signs and lab results for 24 months. Tumor tissue PD-L1 analysis was required where available.
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| Experiment 6 Reporting the Activity Date of This ADC | [6] | ||||
| Patients Enrolled |
Key eligibility: ECOG 0-1, ≥1 measurable lesion, adequate organ function. Phase II required EGFR-mutant NSCLC with prior EGFR-TKI and platinum failure. Major exclusions: uncontrolled CNS metastases, grade ≥3 immune-related AEs, active ILD, significant cardiovascular disease (NYHA II+ heart failure, QTc ≥450/470ms), active infections (HIV/HBV/HCV excluded), or recent immunosuppressants/CYP modulators. Contraception was mandatory for 6 months post-treatment.
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| Administration Dosage |
Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first)
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| Related Clinical Trial | |||||
| NCT Number | NCT06848699 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description | A Phase Ib/ II Clinical Study to Evaluate the Safety ,Torlerbility , and Efficacy of HLX43 (Anti-PD-L1 ADC) in Combination with Serplulimab (anti-PD-1 Humanized Monocl ) in Patients with Advanced/metastatic Solid Tumors | ||||
| Primary Endpoint |
Primary endpoints included DLT assessment (21 days post-dose), MTD determination (12 months), and IRRC-assessed ORR (24 weeks) per RECIST v1.1 for HLX43 combined with serplulimab in advanced solid tumors (Phase Ib) and EGFR-mutated NSCLC (Phase II).
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| Other Endpoint |
Secondary objectives comprised comprehensive safety monitoring (NCI CTCAE v5.0 until 90 days post-treatment), RP2/3D determination (12 months), investigator/IRRC-assessed PFS (15 months), investigator-assessed ORR (24 weeks), and OS (25 months). Tumor PD-L1 expression analysis was required.
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| Experiment 7 Reporting the Activity Date of This ADC | [7] | ||||
| Patients Enrolled |
Key eligibility criteria: Age 18-75, ECOG 0-1, ≥1 measurable lesion, adequate organ function. Major exclusions: active autoimmune/CNS diseases, grade ≥3 irAEs, uncontrolled cardiovascular conditions (NYHA II+ heart failure, QTc ≥450/470ms), active infections (HIV/HBV/HCV), recent immunosuppressants/CYP modulators, or live vaccines within 28 days. Contraception is required for 6 months post-treatment. HCC patients require Child-Pugh A liver function.
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| Administration Dosage |
Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), until progressive disease (PD) without any clinical benefit, initiation of other anti-tumor therapies, death, intolerable toxicity, or withdraw the informed consent (whichever occurs first).
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| Related Clinical Trial | |||||
| NCT Number | NCT06115642 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of HLX43 (Anti-PD-L1 ADC) in Patients With Advanced/Metastatic Solid Tumors | ||||
| Primary Endpoint |
Primary safety endpoints include DLT evaluation (21 days post-first dose) and MTD determination for HLX43 in advanced solid tumors. DLTs are defined as treatment-related AEs impacting dose escalation, with MTD being the highest dose where ≤1/6 patients experience DLTs during the 3-week observation period.
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| Other Endpoint |
Key efficacy and pharmacokinetic measures include investigator-assessed ORR/DOR/PFS/OS (all up to 24 months), along with HLX43 pharmacokinetics (Cmax, Tmax, T1/2 within 21 days) and immunogenicity (ADA/Nab incidence up to 24 months). Safety monitoring covers TEAEs until 90 days post-last dose. Tumor PD-L1 and DDX5 expression analysis is required.
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References