Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ID: DRG0PHKMG)
| ADC Name |
roltotatug vedotin
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| Synonyms |
roltotatug vedotin; TORL-4-500
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| Organization |
TORL Biotherapeutics (Originator)
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| Drug Status |
Phase 1
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| Structure |
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| Antibody Name |
Roltotatug
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Antibody Info | ||||
| Antigen Name |
Protein delta homolog 1 (DLK1)
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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 disease landscape of This ADC
2027 Update
The clinical trial pipelines of This ADC
General Information of The Activity Data Related to This ADC
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] | ||||
| Patients Enrolled |
Eligible patients must have advanced solid tumors (RECIST 1.1 measurable) with ECOG 0-1 and adequate organ function. Exclusions include: unresolved treatment toxicities (>Grade 1); recent anticancer therapy (14-day/28-day washout for small molecules/biologics); active brain metastases; uncontrolled medical conditions/organ dysfunction; significant cardiac disease; MDS/AML history; recent malignancies (except cured skin cancers/low-risk DCIS/prostate cancer); and pregnancy/breastfeeding.
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| Administration Dosage |
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| Related Clinical Trial | |||||
| NCT Number | NCT06005740 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase 1, First in Human Study of TORL-4-500 in Patients with Advanced Cancer | ||||
| Primary Endpoint |
The safety profile including AE/SAE incidence and severity (graded by NCI-CTCAE v5.0) will be monitored for two years. The study will establish the MTD (highest dose with <33% DLTs among 6 evaluable participants in 28 days) and determine RP2D based on MTD, safety data, and pharmacokinetics.
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| Other Endpoint |
Efficacy measures include ORR (CR+PR per RECIST 1.1), DOR from first response to progression/death, PFS from treatment initiation to progression/death, and TTR over two years. Survival rates (1-/2-year OS) will be tracked. Immunogenicity (ADA positivity) and comprehensive PK parameters (Cmax/Cmin/Tmax/AUC/Vz/CL/Rac) for TORL-4-500 will be assessed at single-dose (21-day) and steady-state (63-day) timepoints.
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