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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 antibody-drug conjugate being developed by Lantheus Holdings, Inc. for oncology indications. It has been studied in prostate cancer and glioblastoma multiforme. The program reached Phase 2 development, and all four of its listed clinical trials are completed.
PSMA ADC has been studied in prostate cancer, including metastatic castration-resistant prostate cancer (mCRPC). Trials enrolled adult male patients with prostate cancer in the United States. It has also been evaluated in glioblastoma multiforme and gliosarcoma. The program is in Phase 2 development.
PSMA ADC is developed by Lantheus Holdings, Inc., which trades under the ticker LNTH. The company sponsored the clinical program evaluating the antibody-drug conjugate in prostate cancer and glioblastoma multiforme.
PSMA ADC is in Phase 2 development. Four clinical trials have been listed for the program, all of which are completed, including Phase 1 and Phase 2 studies. No active trials are currently listed for PSMA ADC.
PSMA ADC has been evaluated in four completed trials: NCT01695044 in metastatic castration-resistant prostate cancer, NCT02020135 as an open-label extension study in mCRPC, NCT01856933 in glioblastoma multiforme and gliosarcoma, and NCT01414296, an extended Phase 1 study in prostate cancer. Total enrollment across these trials was 190 patients.