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PSMA ADC · 5 trials · 4 indications
The response assessment in neuro-oncology (RANO) will be used to define radiographic response. (PD): A \>25% increase in tumor area (product of two diameters) OR appearance of a new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Total serum PSA (prostate-specific antigen) was measured at baseline and had at least one post-baseline assessment. PSA response was examined at two levels: at least 30% decrease or at least 50% decrease in serum PSA. Response was assessed as the maximum decrease over the extension study. Response was defined as any decrease from baseline of at least 30% or 50%.
Circulating tumor cells (CTC) response was measured at baseline and had at least one post-baseline assessment. Response was assessed as the maximum decrease over the extension study. Response was defined as any decrease from baseline of at least 50%.
Overall radiologic response was measured at baseline and post-baseline. Imaging techniques used at screening were used throughout the study. The preferred imaging techniques include: bone scan, contrast enhanced CT of chest, contrast enhanced CT of pelvis, and contrast enhanced CT of upper \& lower abdomen. Best overall radiologic response (confirmed), target and non-target lesions, was defined as responses in bone, visceral or nodal metastases according to the Modified Response Evaluation Criteria (RECIST 1.1). The best overall radiologic response is the best response recorded from the start of the treatment until disease progression/recurrence (taking, as reference for progressive disease, the smallest measurements recorded since the treatment started). The subject's best response assignment depended on the achievement of both measurement and confirmation criteria.
Safety and tolerability of PSMA ADC as measured by all adverse events, hematology, blood chemistry, and urine values, vital signs, electrocardiogram, and physical exam.
| Arm | Type | Description |
|---|---|---|
| PSMA ADC | EXPERIMENTAL | 2.5 mg/kg, IV, over 60 minutes every 3 weeks |
| Arm 1: PSMA ADC | EXPERIMENTAL | Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required. |
| Arm 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| PSMA ADC | DRUG | 2.5 mg/kg, IV, over 60 minutes every 3 weeks |
Inclusion Criteria: * Males and females Histologically confirmed GBM (Patients with gliosarcoma are also eligible) * Assessable or measurable disease by MRI * Progression after prior treatment that includes radiation, temozolomide and bevacizumab. -\> 4 weeks since prior chemotherapy, bevacizuma...
PSMA ADC is an investigational small molecule being studied for prostate cancer and glioblastoma multiforme (GBM). It has been evaluated in clinical trials for metastatic castration-resistant prostate cancer (mCRPC) and GBM, including gliosarcoma. PSMA ADC is not approved and remains in clinical development.
PSMA ADC targets prostate-specific membrane antigen (PSMA), as indicated by its name and clinical trial titles. It is designed as an antibody-drug conjugate directed at PSMA, which is expressed in prostate cancer and other solid tumors. The drug's mechanism involves binding to PSMA to deliver a cytotoxic payload.
PSMA ADC is developed by Lantheus Holdings, Inc., a company traded on the NASDAQ under the ticker LNTH. Lantheus is the sponsor of the clinical trials evaluating PSMA ADC for prostate cancer and glioblastoma multiforme.
PSMA ADC has completed Phase 1 and Phase 2 clinical trials. It is not FDA approved and is no longer in active clinical development, as all four trials listed are completed. The drug remains investigational with no ongoing trials registered.
PSMA ADC has been studied in four completed trials: NCT01414283 (Phase 1, prostate cancer, 52 patients), NCT01414296 (Phase 1 extension, prostate cancer, 10 patients), NCT01695044 (Phase 2, mCRPC, 119 patients), and NCT01856933 (Phase 2, GBM, 6 patients). All trials were conducted in the United States.
PSMA ADC is an antibody-drug conjugate (ADC) targeting prostate-specific membrane antigen. Its full name is Prostate-specific Membrane Antigen Antibody-Drug Conjugate, as used in clinical trial titles. It is not known by any other alternative names.