Antibody Information
General Information of This Antibody
| Antibody ID | ANTI0LOHFP |
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| Antibody Name | Anti-CLDN18.2 antibody |
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| Antigen Name | Claudin-18.2 (CLDN18.2) |
Antigen Info | ||||
| Click to Show/Hide the Sequence Information of This Antibody | ||||||
| Heavy Chain Sequence |
QVQLVQSGAEVKKPGSSVKVSCKASGYTFTNYWLHWVRQAPGQGLEWMGMHPISGSSNYA
QKFQGRATLTVDKSTSTAYMELSSLRSEDTAVYYCARGLILSAMDWGQGTLVTVSSASTK GPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYS LSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVF LFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYR VVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKN QVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGN VFSCSVMHEALHNHYTQKSLSLSPGK Click to Show/Hide
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| Light Chain Sequence |
EIVLTQSPATLSLSPGERATLSCKASENVKTYVSWYQQKPGQSPRLLIYEASNRVTGVPA
RFSGSGSGTDFTLTISSLEPEDFAVYFCGQTYSFPPTFGQGTKVEIKRTVAAPSVFIFPP SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC Click to Show/Hide
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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
XNW27011 [Phase 3]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
50%
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| Patients Enrolled |
Eligible patients are ≥18 years old with advanced solid tumors (gastric/GEJ adenocarcinoma, pancreatic, ovarian, etc.), measurable disease (RECIST 1.1), ECOG ≤2, and adequate organ function. Phase II requires CLDN18.2-positive tumors. Exclusions include prior anti-CLDN18.2 therapy, severe allergies to ADC components, uncontrolled comorbidities (cardiovascular, infections, third-space effusions), recent major surgery/radiotherapy, or pregnancy. Both phases mandate contraception compliance.
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| Administration Dosage |
As of Apr. 15, 2024, 16 pts were enrolled in 6 dose cohorts from 0.6 to 6.0 mg/kg, including 11 GC/GEJC, 2 OC, 2 PC, and 1 duodenal periampullary adenocarcinoma (ECOG 0-1, majority of pts received ≥3 lines of prior therapy).
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| Related Clinical Trial | |||||
| NCT Number | NCT06792435 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description |
A Phase I/II, First-in-Human Study of XNW27011 in Patients with Locally Advanced And/or Metastatic Solid Tumors
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| Primary Endpoint |
This study aims to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of XNW27011 in a dose escalation phase (Phase I) for patients with locally advanced/metastatic solid tumors, assessing dose-limiting toxicities (DLTs) during the first 3-week cycle. The Phase II expansion phase will evaluate objective response rate (ORR) at RP2D, measuring complete (CR) and partial responses (PR) over approximately 2 years.
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| Other Endpoint |
Safety assessments include adverse event monitoring (NCI CTCAE v5.0), pharmacokinetic profiling (AUC, Cmax, Ctrough), immunogenicity (anti-drug antibodies), and CLDN18.2 biomarker correlation with efficacy. Phase II will further assess disease control rate (DCR), duration of response (DOR), time to response (TTR), progression-free survival (PFS), and overall survival (OS) at RP2D over 2 years.
Click to Show/Hide
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| Experiment 2 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Disease control rate (DCR) |
86%
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| Patients Enrolled |
Eligible patients are ≥18 years old with advanced solid tumors (gastric/GEJ adenocarcinoma, pancreatic, ovarian, etc.), measurable disease (RECIST 1.1), ECOG ≤2, and adequate organ function. Phase II requires CLDN18.2-positive tumors. Exclusions include prior anti-CLDN18.2 therapy, severe allergies to ADC components, uncontrolled comorbidities (cardiovascular, infections, third-space effusions), recent major surgery/radiotherapy, or pregnancy. Both phases mandate contraception compliance.
Click to Show/Hide
|
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| Administration Dosage |
As of Apr. 15, 2024, 16 pts were enrolled in 6 dose cohorts from 0.6 to 6.0 mg/kg, including 11 GC/GEJC, 2 OC, 2 PC, and 1 duodenal periampullary adenocarcinoma (ECOG 0-1, majority of pts received ≥3 lines of prior therapy).
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| Related Clinical Trial | |||||
| NCT Number | NCT06792435 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description |
A Phase I/II, First-in-Human Study of XNW27011 in Patients with Locally Advanced And/or Metastatic Solid Tumors
|
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| Primary Endpoint |
This study aims to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of XNW27011 in a dose escalation phase (Phase I) for patients with locally advanced/metastatic solid tumors, assessing dose-limiting toxicities (DLTs) during the first 3-week cycle. The Phase II expansion phase will evaluate objective response rate (ORR) at RP2D, measuring complete (CR) and partial responses (PR) over approximately 2 years.
Click to Show/Hide
|
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| Other Endpoint |
Safety assessments include adverse event monitoring (NCI CTCAE v5.0), pharmacokinetic profiling (AUC, Cmax, Ctrough), immunogenicity (anti-drug antibodies), and CLDN18.2 biomarker correlation with efficacy. Phase II will further assess disease control rate (DCR), duration of response (DOR), time to response (TTR), progression-free survival (PFS), and overall survival (OS) at RP2D over 2 years.
Click to Show/Hide
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