Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0PHKMG
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| 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 |
MMAE
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Payload Info | ||||
| Therapeutic 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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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 | ||
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| Unspecific solid tumor |
1 Trials
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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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