Payload Information

General Information of This Payload
Payload ID
PAY0JXVNR
Name
Amberstatin-269
Synonyms
Amberstatin-269
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Each Antibody-drug Conjugate Related to This Payload
Full Information of The Activity Data of The ADC(s) Related to This Payload
ARX-517 [Phase 1]
 ADC Info 
Identified from the Human Clinical Data
Click To Hide/Show 2 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
Patients Enrolled
Major exclusions include recent chemotherapy/hormonal/radiation therapy (varies by cohort), prior taxanes or ARPIs (specific to cohorts), corticosteroid use (>10mg prednisone equivalent), active CNS metastases, other malignancies (last 2 years), QTc >480ms, lung disease (last 12 months), ocular disorders, grade ≥2 neuropathy, and proteinuria (>1g/24h). Seizure history disqualifies for apalutamide combination cohorts.

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Administration Dosage
ARX517 will be administered via intravenous (IV) infusion, with the initial treatment regimen by weight-based infusion at an interval of every 3 weeks. Other treatment regimen may be explored.
Related Clinical Trial
NCT Number NCT04662580  Phase Status PHASE1
Clinical Description
A Phase 1, Multicenter, Open-Label, Dose-Escalation, and Dose-Expansion Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of ARX517 as Monotherapy and in Combination With Androgen Receptor Pathway Inhibitors in Subjects With Metastatic Prostate Cancer
Primary Endpoint
The study will assess safety and tolerability of ARX517 (alone or combined with ARPIs) through adverse event incidence/severity (CTCAE v5) over 1.5 years, alongside pharmacokinetic parameters (AUC, Cmax, Ctrough) and immunogenicity (ADA incidence) over 3 years. Efficacy endpoints include overall survival (OS), PSA response rates (PSA30/50/90), and progression-free survival (PFS).

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Other Endpoint
Key inclusion criteria require males ≥18 with prostate adenocarcinoma, adequate LHRH therapy (testosterone ≤50ng/dL for mCRPC), prior treatments per cohort, documented progression (mCRPC) or high-volume metastases (mCSPC), and PSMA-positive lesions. Adequate hematologic/organ function and PSMA PET eligibility are mandatory.
Experiment 2 Reporting the Activity Date of This ADC [2]
Related Clinical Trial
NCT Number NCT04662580  Phase Status Phase 1/2
Clinical Description
A phase 1/2, multicenter, open-label, dose-escalation, and dose-expansion study to evaluate the safety, pharmacokinetics, and anti-tumor activity of ARX517, with randomized comparison to investigator's choice of treatment, in subjects with metastatic castration-resistant prostate cancer who are resistant or refractory to prior standard therapies.
References
Ref 1 ARX517/JNJ-95298177 as Monotherapy or Combination Therapy in Subjects With Metastatic Prostate Cancer
Ref 2 A Phase 1/2, Multicenter, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics, and Anti-tumor Activity of ARX517, With Randomized Comparison to Investigator's Choice of Treatment, in Subjects With Metastatic Castration-resistant Prostate Cancer Who Are Resistant or Refractory to Prior Standard Therapies, NCT04662580