Antibody Information
General Information of This Antibody (ID: ANTI0QDMBJ)
| Antibody Name | Trastuzumab/Pertuzumab biparatopic bsAb |
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| Antigen Name | HER2 |
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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
KM501 [Phase 1]
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
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| 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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