Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ID: DRG0GTQOC)
| ADC Name |
PSMA ADC
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| Synonyms |
PSMA ADC
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| Organization |
Progenics Pharmaceuticals (Originator)
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| Drug Status |
Phase 2 (discontinued)
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| Drug-to-Antibody Ratio |
3~3.5
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| Structure |
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| Antibody Name |
Fully human anti-PSMA IgG1 mAb
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Antibody Info | ||||
| Antigen Name |
Glutamate carboxypeptidase 2 (FOLH1)
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Antigen Info | ||||
| Payload Name |
Monomethyl auristatin E
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Payload Info | ||||
| Payload 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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2027 Update
The disease landscape of This ADC
2027 Update
The clinical trial pipelines of This ADC
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
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 (≥18 years, KPS >60) must have histologically confirmed GBM, prior progression post-standard therapy (≥4 weeks since chemo/bevacizumab, ≥3 weeks post-radiation), MRI-measurable disease, and stable organ/lab values (ANC ≥1000/mm <sup>3</sup>, platelets ≥100k/mm <sup>3</sup>, bilirubin ≤2.0 mg/dL). Exclusions: non-GBM malignancies (excluding specific low-risk cancers), QTc >500 msec, recent GBM treatment (within 3 weeks), PSMA ADC/MMAE exposure, pancreatitis history, or uncontrolled infections/cardiopulmonary disease. Effective contraception is mandatory.
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| Administration Dosage |
2.5 mg/kg, IV, over 60 minutes every 3 weeks
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| Related Clinical Trial | |||||
| NCT Number | NCT01856933 | Clinical Status | PHASE2 | ||
| Clinical Description | BrUOG 263: PSMA ADC for Recurrent Glioblastoma Multiforme (GBM): A Phase II Brown University Oncology Research Group Study | ||||
| Primary Endpoint |
The study evaluates response rate (using RANO criteria) in recurrent glioblastoma patients previously treated with radiation, temozolomide, and bevacizumab, defining progression as >25% tumor increase, new lesions, or clinical deterioration (followed for up to 1 year).
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| Other Endpoint |
Safety assessment tracks toxicities (including unrelated events) in patients receiving PSMA ADC for recurrent GBM, recorded every 3 weeks until 30 days post-treatment (approximately 6 months total).
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Eligible participants must have confirmed progressive castration-resistant metastatic prostate cancer with prior taxane-based chemotherapy and ECOG status 0-1. Key exclusions include significant cardiac/pulmonary disease, active infections requiring antibiotics, prior PSMA-targeted therapy, or a history of substance abuse.
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| Administration Dosage |
PSMA ADC administered IV
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| Related Clinical Trial | |||||
| NCT Number | NCT01414283 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase 1 Dose-escalation Study of PSMA ADC in Subjects With Progressive, Castration-resistant, Metastatic Prostate Cancer | ||||
| Primary Endpoint |
The study aims to determine the maximum tolerated dose (MTD) of PSMA ADC in patients with progressive, castration-resistant metastatic prostate cancer, with toxicity observation over a 13-week timeframe.
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| Experiment 3 Reporting the Activity Date of This ADC | [3] | ||||
| Patients Enrolled |
Eligible patients must have completed prior PSMA ADC 1301 study with observed treatment benefit, confirmed progressive castration-resistant metastatic prostate cancer, prior taxane chemotherapy, and ECOG 0-1. Exclusions: significant cardiac/pulmonary disease, active infections requiring antibiotics, or history of substance abuse.
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| Administration Dosage |
PSMA ADC administered IV
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| Related Clinical Trial | |||||
| NCT Number | NCT01414296 | Clinical Status | PHASE1 | ||
| Clinical Description | Extended 39-Week Study of PSMA ADC Following the Initial 12-Week Dose-escalation Study in Subjects With Progressive, Castration-resistant, Metastatic Prostate Cancer | ||||
| Primary Endpoint |
The study evaluates the safety of PSMA ADC over 39 weeks by monitoring adverse events, laboratory results (hematology, chemistry, urinalysis), vital signs, ECG, and physical exams in eligible participants.
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| Experiment 4 Reporting the Activity Date of This ADC | [4] | ||||
| Patients Enrolled |
Eligible participants must have metastatic castration-resistant prostate cancer, either with prior taxane chemotherapy (requiring Sponsor approval if >2 regimens) or chemotherapy-naïve (if ineligible/refused Radium-223), plus progression on abiraterone/enzalutamide, ECOG 0-2, and ≥6-month life expectancy. Exclusions include recent radiation/chemotherapy/radiopharmaceuticals, PSMA ADC/MMAE-based ADC treatment (unless Sponsor-approved), significant cardiac/pulmonary disease, active infections, pancreatitis, or substance abuse history.
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| Administration Dosage |
PSMA ADC administered IV at 2.5 mg/kg Q3W for 8 cycles or 2.3 mg/kg Q3W for 8 cycles.
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| Related Clinical Trial | |||||
| NCT Number | NCT01695044 | Clinical Status | PHASE2 | ||
| Clinical Description | A Phase 2, Open-label, Multicenter Study of PSMA ADC in Subjects With Metastatic Castration-resistant Prostate Cancer | ||||
| Primary Endpoint |
This study evaluates efficacy endpoints at 24 weeks including PSA response (≥30% or ≥50% decrease from baseline), CTC response (≥30% or ≥50% reduction), and radiologic response (assessed via CT/bone scans per RECIST 1.1, tracking target/non-target lesions and bone/visceral/nodal metastases for best overall response before progression).
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| Experiment 5 Reporting the Activity Date of This ADC | [5] | ||||
| Patients Enrolled |
Eligible subjects had completed the PSMA ADC 2301 trial with anticipated continued benefit, ECOG 0-2, and maintained androgen-deprivation therapy if applicable, with contraception compliance. Exclusions: active infections (e.g., UTIs), hypersensitivity to PSMA ADC components/monoclonal antibodies, severe cardiac/pulmonary disease, or conditions compromising study participation/Safety evaluation.
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| Administration Dosage |
Upon recommendation from the PI and after Sponsor approval, a subject benefiting from treatment could have received up to eight additional doses Q3W. Subjects were weighed prior to each cycle and dosing was calculated on a mg/kg basis prior to each dose, with a maximum weight of 100 kg for dosing calculations.
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| Related Clinical Trial | |||||
| NCT Number | NCT02020135 | Clinical Status | PHASE2 | ||
| Clinical Description | An Open-label Treatment Extension of PSMA ADC in Subjects With Metastatic Castration-resistant Prostate Cancer (mCRPC) | ||||
| Primary Endpoint |
The trial assessed efficacy at 25 weeks through PSA response (≥30% or ≥50% decrease from baseline), CTC response (≥50% reduction), and radiologic response (using bone/CT scans per RECIST 1.1 to evaluate target/non-target lesions and metastatic sites), with responses defined by the maximum observed decreases post-baseline.
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References