Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0KYOBC
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| ADC Name |
Ixotatug vedotin
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| Synonyms |
ixotatug vedotin; TORL-1-23; CLDN6-23-ADC
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| Organization |
TORL Biotherapeutics (Originator)
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| Drug Status |
Phase 2
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| Drug-to-Antibody Ratio |
4
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| Structure |
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| Antibody Name |
Ixotatug
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Antibody Info | ||||
| Antigen Name |
Claudin-6 (CLDN6)
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Antigen Info | ||||
| Payload Name |
Monomethyl auristatin E
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Payload Info | ||||
| Payload Target |
Microtubule (MT)
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Target Info | ||||
| Linker Name |
Mc-Val-Cit-PABC
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Linker Info | ||||
| Conjugate Type |
Random Cysteines
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| Combination Type |
vedotin
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2027 Update
The indication landscape of This ADC
2027 Update
The clinical trial pipelines of This ADC
| Indication | Phase 1 | Phase 2 | Phase 3 | Approved | ||
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| Unspecific solid tumor |
1 Trials
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| Lung cancer |
1 Trials
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| Ovarian cancer |
1 Trials
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| Endometrial 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] | ||||
| Efficacy Data | Partial Response (PR) |
33.30%
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| Patients Enrolled |
Inclusion: Adults with advanced solid tumors (RECIST 1.1-measurable), ECOG 0-1, adequate organ function. Exclusion: Unresolved toxicities (>Grade 1), recent anticancer therapy (14-28 days prior), active brain metastases, uncontrolled comorbidities (cardiac/infectious), MDS/AML history, concurrent malignancies (except non-melanoma skin/indolent cancers), pregnancy/breastfeeding, or clinically significant conditions per investigator judgment.
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| Administration Dosage |
19 patients with platinum-resistant/refractory ovarian cancer were evaluated across 8 dose levels (0.2 to 2.4 mg/kg IV every 3 weeks, 21 day cycles) (data cutoff 01APR2023).
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| Related Clinical Trial | |||||
| NCT Number | NCT05103683 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase 1, First in Human, Dose-Escalation Study of TORL-1-23 in Participants with Advanced Cancer | ||||
| Primary Endpoint |
The primary safety endpoints include incidence/severity of adverse events (AEs) and serious AEs per NCI-CTCAE v5.0 (monitored for 2 years), as well as determination of Maximum Tolerated Dose (MTD) (<33% DLT rate in first 28 days) and Recommended Phase 2 Dose (RP2D) based on accumulated safety/PK data over 2 years.
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| Other Endpoint |
Key efficacy measures are Objective Response Rate (ORR; CR+PR per RECIST 1.1), Duration of Response (DOR), Progression-Free Survival (PFS), Time to Response (TTR), and 1-/2-Year Overall Survival rates (1YOS/2YOS). Immunogenicity (ADA-positive participants) and 12 detailed pharmacokinetic parameters (Cmax, Cmin, t1/2, AUCinf, etc.) are assessed over 21-63 days with multiple serum concentration metrics.
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Inclusion criteria: Women ≥18 with CLDN6-positive (per central assay), histologically confirmed advanced/metastatic high-grade serous/endometrioid ovarian, primary peritoneal, or fallopian tube cancer; platinum-resistant (progression ≤6 months post-platinum); 1-3 prior lines; measurable disease; ECOG 0-1; adequate organ function. Exclusions: Platinum-refractory disease (progression ≤3 months post-first-line platinum), prior CLDN6/MMAE-ADC therapy, active brain metastases/leptomeningeal disease, Grade≥2 neuropathy, uncontrolled infections/cardiopulmonary conditions, strong CYP3A4/P-gp modifiers use, or concurrent malignancies within 3 years. CNS mets require prior stabilization.
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| Administration Dosage |
2.4, 3.0, 3.4 mg/kg intravenous infusion on Day 1 of every 3-week cycle.
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| Related Clinical Trial | |||||
| NCT Number | NCT06690775 | Clinical Status | PHASE2 | ||
| Clinical Description | Catalina-2: a Phase 2 Study Evaluating the Efficacy and Safety of TORL-1-23 in Women with Advanced Platinum-Resistant Epithelial Ovarian Cancer (Including Primary Peritoneal and Fallopian Tube Cancers) Expressing Claudin 6 | ||||
| Primary Endpoint |
The primary efficacy endpoint is Objective Response Rate (ORR) per RECIST v1.1, assessed by Blinded Independent Central Review (BICR), in women with advanced platinum-resistant ovarian cancer (PROC) expressing CLDN6, evaluated over approximately 40 months with periodic assessments from first dose until disease progression.
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| Other Endpoint |
Secondary efficacy measures include Duration of Response (DOR), ORR by investigator assessment, Progression-Free Survival (PFS), Overall Survival (OS) (tracked over ~40 months), CA-125 response per GCIG criteria, and safety/tolerability profiles (AE incidence/severity per CTCAE v5.0 monitored until 30 days post-treatment). PK/PD effects are also evaluated.
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| Experiment 3 Reporting the Activity Date of This ADC | [3] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT05103683 | Clinical Status | Phase 1 | ||
| Clinical Description | A phase 1, first in human, dose-escalation study of TORL-1-23 in participants with advanced cancer. | ||||
References
