Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0GTQOC
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| 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 |
MMAE
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Payload Info | ||||
| Therapeutic 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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The indication landscape of This ADC(2027 Update)
The clinical trial pipeline of This ADC(2027 Update)
| Indication | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | New Drug Application | Approved | ||||||
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| Brain cancer |
1 Trials
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| Prostate cancer |
2 Trials
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2 Trials
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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