General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0HQVXQ
ADC Name
Zarutatug vedotin
Synonyms
zarutatug vedotin; TORL-3-600
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Organization
TORL Biotherapeutics (Originator)
Drug Status
Phase 1 (discontinued)
Structure
Antibody Name
Zarutatug
 Antibody Info 
Antigen Name
Cadherin-17 (CDH17)
 Antigen Info 
Payload Name
MMAE
 Payload Info 
Therapeutic Target
Microtubule (MT)
 Target Info 
Linker Name
Mc-Val-Cit-PABC
 Linker Info 
Conjugate Type
Random Cysteines
Combination Type
vedotin
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
Colorectal cancer
1 Trials
Trial ID
NCT05948826
Unspecific solid tumor
1 Trials
Trial ID
NCT05948826
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Click To Hide/Show 1 Activity Data Related to This Level
Standard Type NCT Number Clinical Status Clinical Trial Description
Undisclosed  NCT05948826
PHASE1
A Phase 1, First in Human, Dose-Escalation Study of TORL-3-600 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 1 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
Patients Enrolled
Eligible patients must have advanced solid tumors with measurable disease (RECIST v1.1), ECOG 0-1, and adequate organ function. Exclusions include unresolved toxicities (>Grade 1, except alopecia), recent anticancer therapy (14-28 days prior), active brain metastases, uncontrolled comorbidities, cardiac disease, MDS/AML history, concurrent malignancies (except certain low-risk cases), and pregnancy/breastfeeding.

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Administration Dosage
.
Related Clinical Trial
NCT Number NCT05948826  Clinical Status PHASE1
Clinical Description A Phase 1, First in Human, Dose-Escalation Study of TORL-3-600 in Participants With Advanced Cancer
Primary Endpoint
The study will assess the incidence and severity of adverse events (AEs) and serious adverse events (SAEs) graded by NCI-CTCAE v5.0 over 2 years, while determining Maximum Tolerated Dose (MTD) based on dose-limiting toxicities (DLTs) in the first 6 evaluable participants within 28 days, and Recommended Phase 2 Dose (RP2D) using safety, tolerability, and pharmacokinetic data.

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Other Endpoint
Efficacy endpoints include Objective Response Rate (ORR), Duration of Response (DOR), Progression-Free Survival (PFS), Time to Response (TTR), 1-Year and 2-Year Overall Survival (1YOS, 2YOS), and immunogenicity via anti-drug antibody (ADA) assessment. Pharmacokinetic parameters [Cmax, Cmin, AUC, t1/2, CL, Vz, Rac, etc.] for TORL-3-600 will be evaluated over 21-63 days.

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References
Ref 1 First in Human Study of TORL-3-600 in Participants With Advanced Cancer