Linker Information
General Information of This Linker
| Linker ID |
LIN0TQTFO
|
|||||
|---|---|---|---|---|---|---|
| Linker Name |
P5 (PEG24)-Val-Cit-PABC
|
|||||
| Antibody-Linker Relation |
Cleavable
|
|||||
| Structure |
|
|||||
|
|
||||||
Each Antibody-drug Conjugate Related to This Linker
Full Information of The Activity Data of The ADC(s) Related to This Linker
TUB-030 [Phase 1/2]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Patients Enrolled |
Eligible patients (≥18 years, ECOG 0-1) had adequate organ function, measurable disease per RECIST v1.1, and resolved prior treatment toxicities (≤grade 1). Exclusions included recent anticancer therapy (<4 weeks/5 half-lives), uncontrolled brain metastases, or inadequate contraception. WOCBP required highly effective contraception during and post-treatment (5 half-lives + 6 months).
Click to Show/Hide
|
||||
| Administration Dosage |
A complete treatment cycle is defined as 21 calendar days. TUB-030 will be administered as an intravenous (IV) solution on day 1 of each treatment cycle
|
||||
| Related Clinical Trial | |||||
| NCT Number | NCT06657222 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description |
A Multicenter FIH Dose Escalation and Optimization Phase I/IIa Trial to Investigate Safety, Tolerability, PK, and Efficacy of the 5T4 ADC TUB-030 in Patients with Advanced Solid Tumors (5-STAR 1-01)
|
||||
| Primary Endpoint |
The MTD was defined as the highest dose where ≤1 of 3 patients experienced DLTs per NCI CTCAE v5.0, assessed from enrollment until 30 days post-treatment.
|
||||
| Other Endpoint |
Safety outcomes included AE incidence, PK parameters (Cmax, Cmin, Tmax, AUC, T1/2), immunogenicity (anti-TUB-030 antibodies), and efficacy (ORR per RECIST 1.1), all evaluated until 30 days post-treatment.
|
||||
TUB-040 [Phase 1/2]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Eligible patients (≥18 years, ECOG 0-1) had incurable solid tumors refractory to SoC, measurable disease, adequate organ function, and resolved prior toxicities (≤grade 1). Exclusions included topoisomerase-I refractory disease, active ILD/pneumonitis, uncontrolled comorbidities, recent live vaccines, or infections (HBV/HCV/HIV exceptions applied). Contraception was mandatory for FCBP.
Click to Show/Hide
|
||||
| Administration Dosage |
A complete treatment cycle is defined as 21 calendar days. TUB-040 will be administered as an intravenous (IV) solution on day 1 of each treatment cycle
|
||||
| Related Clinical Trial | |||||
| NCT Number | NCT06303505 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description |
A First-in-human Dose Escalation and Optimization Phase I/IIa Study to Investigate Safety, Tolerability, PK, and Efficacy of the NaPi2b ADC TUB-040 in Patients With Platinum-resistant High-grade Ovarian Cancer (PROC) or r/r Adenocarcinoma Non-small Cell Lung Cancer (NSCLC)
|
||||
| Primary Endpoint |
The MTD was determined as the highest dose where ≤1 of 3 patients experienced DLTs per NCI CTCAE v5.0, evaluated from enrollment until 30 days post-treatment.
|
||||
| Other Endpoint |
PK parameters (Cmax, Cmin, Tmax, AUC, T1/2) for TUB-040 components (ADC, mAb, payload) and immunogenicity (anti-TUB-040 antibodies) were assessed until 30 days post-treatment, alongside efficacy (ORR per RECIST 1.1).
|
||||
References