Antibody Information
General Information of This Antibody
| Antibody ID | ANTI0ZMJJK |
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| Antibody Name | Anti-5T4 antibody |
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| Antigen Name | 5T4 |
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Each Antibody-drug Conjugate Related to This Antibody
Full Information of The Activity Data of The ADC(s) Related to This Antibody
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).
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| 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
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| 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)
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| 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.
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| 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.
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XB010 [Phase 1]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Key inclusion criteria: age ≥18; ECOG 0-1; adequate organ function; histologically confirmed advanced/metastatic solid tumors (NSCLC, HR+ BC, HNSCC, ESCC, TNBC); protocol compliance capability with signed informed consent.
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| Administration Dosage |
IV administration of XB010
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| Related Clinical Trial | |||||
| NCT Number | NCT06545331 | Clinical Status | PHASE1 | ||
| Clinical Description |
A Dose-Escalation and Expansion Study of XB010 as a Single Agent and Combination Therapy in Subjects With Locally Advanced or Metastatic Solid Tumors
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| Primary Endpoint |
Primary endpoints include MTD/RDE determination (18 months), safety profile (AE/SAE incidence), tolerability (exposure duration/dose intensity), and preliminary antitumor activity (ORR per RECIST 1.1) for XB010 monotherapy and combination therapy.
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| Other Endpoint |
Secondary endpoints comprise PK parameters (Cmax, Tmax, clearance, AUC, Cmin) and immunogenicity (ADA analysis) for both dose-escalation (18 months) and cohort-expansion stages (24 months), along with continued tolerability assessments.
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References