Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0QCCTW
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| ADC Name |
KM501
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| Synonyms |
KM501; KM254; XZP-KM501
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| Organization |
Comeon Biopharma (Originator)
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| Drug Status |
Phase 1
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| Antibody Name |
Trastuzumab/Pertuzumab biparatopic bsAb
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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 |
MMAE
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Payload Info | ||||
| Therapeutic Target |
Microtubule (MT)
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Target Info | ||||
| Linker Name |
Undisclosed
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| Conjugate Type |
Undisclosed
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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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| Colorectal cancer |
1 Trials
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| Endometrial cancer |
1 Trials
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| Gastric cancer |
1 Trials
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| Gastroesophageal junction adenocarcinoma |
1 Trials
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| Lung cancer |
1 Trials
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| Ovarian cancer |
1 Trials
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| Unspecific solid tumor |
1 Trials
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| Urothelial cancer |
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 |
Eligible participants (18-75 years) must have HER2-expressing/amplified/mutated advanced solid tumors (breast/urothelial/gastric/ovarian/endometrial/colorectal/NSCLC), ECOG 0-1, measurable/evaluable lesions, adequate organ function (hematologic/hepatic/renal), and reproductive safeguards (contraception for 6 months post-treatment), with HER2 status confirmed by IHC/ISH/NGS in archival/current biopsy samples.
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| Administration Dosage |
1a: The program evaluated six dose levels, i.e., 0.1, 0.3, 0.6, 1.2, 1.8, 2.4 mg/kg, An accelerated titration was performed in the 0.1 and 0.3 mg/kg dose groups, and then a Bayesian optimal interval design was used to determine MTDS for four subsequent dose levels. Ib: The antitumor activity of KM501 monotherapy in subjects with specific types of tumors that are HER2-positive or express, amplify, or mutate will be evaluated at the RP2D dose level
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| Related Clinical Trial | |||||
| NCT Number | NCT05804864 | Clinical Status | PHASE1 | ||
| Clinical Description | A Single-arm, Open, Multicenter Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Efficacy of the KM501 Double-antibody ADC in Subjects With Advanced Solid Tumors That Express, Amplify, or Mutate HER2 | ||||
| Primary Endpoint |
The study evaluates MTD/RP2D determination and treatment-related AEs (CTCAE v5.0) in Part 1a (dose escalation), while Part 1b assesses ORR (investigator-assessed CR/PR per RECIST 1.1) and long-term efficacy outcomes (PFS/DCR/OS) over 2-3 years in HER2-altered solid tumors.
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| Other Endpoint |
Pharmacokinetic analyses (AUC/Cmax/T-HALF) and immunogenicity (ADA) are conducted across both parts, with safety monitoring (AEs) extended through Part 1b, providing comprehensive drug exposure and tolerability data alongside efficacy measures (ORR/PFS/DCR/OS) for up to 3 years.
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