General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0KYOBC
ADC Name
Ixotatug vedotin
Synonyms
ixotatug vedotin; TORL-1-23; CLDN6-23-ADC
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Organization
TORL Biotherapeutics (Originator)
Drug Status
Phase 2
Drug-to-Antibody Ratio
4
Structure
Antibody Name
Ixotatug
 Antibody Info 
Antigen Name
Claudin-6 (CLDN6)
 Antigen Info 
Payload Name
Monomethyl auristatin E
 Payload Info 
Payload Target
Microtubule (MT)
 Target Info 
Linker Name
Mc-Val-Cit-PABC
 Linker Info 
Conjugate Type
Random Cysteines
Combination Type
vedotin
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
Unspecific solid tumor
1 Trials
Trial ID
NCT05103683
Lung cancer
1 Trials
Trial ID
NCT05103683
Ovarian cancer
1 Trials
Trial ID
NCT05103683
Endometrial cancer
1 Trials
Trial ID
NCT05103683
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Click To Hide/Show 3 Activity Data Related to This Level
Standard Type NCT Number Clinical Status Clinical Trial Description
Partial Response (PR)  NCT05103683
PHASE1
A Phase 1, First in Human, Dose-Escalation Study of TORL-1-23 in Participants with Advanced Cancer
Undisclosed  NCT06690775
PHASE2
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

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Undisclosed  NCT05103683
Phase 1
A phase 1, first in human, dose-escalation study of TORL-1-23 in participants with advanced cancer.
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
Click To Hide/Show 3 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
Efficacy Data Partial Response (PR)
33.30%
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).
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.
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 &ge;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 &le;6 months post-platinum); 1-3 prior lines; measurable disease; ECOG 0-1; adequate organ function. Exclusions: Platinum-refractory disease (progression &le;3 months post-first-line platinum), prior CLDN6/MMAE-ADC therapy, active brain metastases/leptomeningeal disease, Grade&ge;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.
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.
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
Ref 1 First in Human Study of TORL-1-23 in Participants with Advanced Cancer
Ref 2 CATALINA-2: a Clinical Study of TORL-1-23 in Platinum-resistant Ovarian Cancer.
Ref 3 A Phase 1, First in Human, Dose-Escalation Study of TORL-1-23 in Participants With Advanced Cancer