Linker Information
General Information of This Linker
| Linker ID |
LIN0PJDMT
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| Linker Name |
Val-Ala dipeptide linker
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| Linker Type |
Unclear
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| Antibody-Linker Relation |
Cleavable
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| Structure |
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Each Antibody-drug Conjugate Related to This Linker
Full Information of The Activity Data of The ADC(s) Related to This Linker
Mirzotamab clezutoclax [Phase 1]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Patients Enrolled |
Inclusion: Solid tumor patients (Part 2a: SCLC; Part 2b: NSCLC/HR+HER2- breast cancer) with measurable disease, ECOG ≤2, prior therapy failure. Breast cancer patients must have CDK4/6 inhibitor failure; NSCLC patients require targeted therapy if actionable mutations present. Exclusion: Active CNS metastases, Grade≥2 neuropathy, unresolved toxicities, active hepatitis/HIV, significant cardiac history, or hypersensitivity to study drug components. Taxane-exposed patients require 2-month washout.
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| Administration Dosage |
Participants will be administered ABBV-155 (various doses).
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| Related Clinical Trial | |||||
| NCT Number | NCT03595059 | Clinical Status | PHASE1 | ||
| Clinical Description |
A Phase 1 First-in-Human Study With ABBV-155 Alone and in Combination With Taxane Therapy in Adults With Relapsed and/or Refractory Solid Tumors
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| Primary Endpoint |
Primary endpoints include MTD/RPTD determination during dose escalation (21-day evaluation) and ORR assessment (RECIST 1.1) with 2-6 month follow-up in expansion phases.
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| Other Endpoint |
Secondary objectives comprise AE monitoring (12 months), efficacy measures (DOR/CR/PFS/OS), PK parameters (Cmax/Tmax/AUCt/AUCinf/t1/2 over 48 days), and cardiac safety (QTcF changes).
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SGN-CD352A [Phase 1 (discontinued)]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Eligible participants must have IMWG-defined multiple myeloma requiring systemic therapy, age ≥18 years, ECOG 0-1, life expectancy >3 months, ≥2 prior lines of therapy (including IMiD and PI), measurable disease, adequate organ function, and negative pregnancy test. Key exclusions include recent malignancies (past 3 years), active CNS disease, severe infections, HIV/HBV/HCV positivity, prior allogeneic transplant, significant pulmonary/cardiovascular comorbidities, or pregnancy/breastfeeding.
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| Administration Dosage |
On the first day of each 28-day cycle, SGN-CD352A will be given IV. The dose of SGN-CD352A is different in each cohort of the study, with the lowest dose in Cohort -1 (4 mcg/kg) and the highest in Cohort 6 (65 mcg/kg). Patients can only be enrolled into a higher dose level arm if lower doses have proven safe.
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| Related Clinical Trial | |||||
| NCT Number | NCT02954796 | Clinical Status | PHASE1 | ||
| Clinical Description |
Phase 1 Study of SGN-CD352A in Patients With Relapsed or Refractory Multiple Myeloma
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| Primary Endpoint |
The study assesses safety through comprehensive evaluation of adverse events (type, incidence, severity, seriousness, and relatedness) monitored for 1 month post-treatment, along with dose-limiting toxicities during the first 28-day cycle.
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| Other Endpoint |
Efficacy outcomes include overall survival, progression-free survival, duration of response (both objective and complete), and response rates (ORR/CR) tracked for approximately 3 years, complemented by immunogenicity analysis (antitherapeutic antibodies) and pharmacokinetic profiling of SGN-CD352A and metabolites over the same period.
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SC-002 [Phase 1 (discontinued)]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [3] | ||||
| Patients Enrolled |
Eligible patients must have histologically confirmed relapsed/refractory SCLC or LCNEC (≤2 prior regimens), measurable disease by RECIST, ECOG 0-1, and adequate organ function. Key exclusions include active CNS metastases, uncontrolled cardiac disease, hepatitis/HIV infection, or conditions compromising study integrity.
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| Administration Dosage |
SC-002 will be administered by IV infusion over approximately 30 minutes every 3 weeks
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| Related Clinical Trial | |||||
| NCT Number | NCT02500914 | Clinical Status | PHASE1 | ||
| Clinical Description |
A Phase 1a/1b Dose Escalation and Expansion Study of Single-agent SC-002 in Subjects With Relapsed or Refractory Small Cell Lung Cancer and Large Cell Neuroendocrine Carcinoma
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| Primary Endpoint |
The study evaluates maximum tolerated dose and safety profile (adverse event incidence) over a 6-month period to establish the therapeutic window of SC-002.
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| Other Endpoint |
Pharmacokinetic analysis of SC-002 includes comprehensive assessment of AUC, Tmax, Cmax, Ctrough, T1/2, CL, and Vss during treatment cycles, with tumor response measured by RECIST v1.1 criteria at 6 months.
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| Experiment 2 Reporting the Activity Date of This ADC | [4] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
14.29%
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| Patients Enrolled |
Small-cell lung cancer (either limited or extensive disease) or large cell neuroendocrine carcinoma that had relapsed or was refractory to treatment following 1 prior systemic chemotherapy and for which no curative therapy was available were eligible for the phase 1a dose-escalation.
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| Administration Dosage |
7 dose levels (0.025-0.40 mg/kg), 3+3 design.
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| Related Clinical Trial | |||||
| NCT Number | NCT02500914 | Clinical Status | Phase 1a/1b | ||
| Clinical Description |
A phase 1a/1b dose escalation and expansion study of single-agent SC-002 in subjects with relapsed or refractory small cell lung cancer and large cell neuroendocrine carcinoma.
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| Primary Endpoint |
All patients (N = 35) were included in response analyses. Five patients (14.29%) overall achieved a PR per investigator assessment,with no patients achieving a CR. One patient each had a PR in the 0.20 and 0.30 mg/kg Q3W dose groups, and 3 patients in the 0.40 mg/kg Q9W dose group, fourteen (40.00%) patients achieved stable disease as their best overall response,and 5 had no or an non-evaluable posttreatment scan.
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| Other Endpoint |
Nineteen patients had tumor samples that were able to be assessed for DLL3 expression by immunohistochemistry. DLL3-positive expression by immunohistochemistry (DLL3 >0%) was confirmed in 17 patients; 5 were DLL3 high (75.00% DLL3 positive cells). Of DLL3-positive patients, 2 (11.80%) achieved a PR, including 1 patient in the 0.20 mg/kg Q3W cohort and 1 DLL3-high patient in the 0.40 mg/kg Q9W cohort.
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| Experiment 3 Reporting the Activity Date of This ADC | [5] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT02500914 | Clinical Status | Phase 1 | ||
| Clinical Description |
A phase 1a/1b dose escalation and expansion study of single-agent SC-002 in subjects with relapsed or refractory small cell lung cancer and large cell neuroendocrine carcinoma.
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References
