Phase 1 Study of AlphaMedix™ in Adult Subjects With SSTR (+) NET
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03466216|
Recruitment Status : Active, not recruiting
First Posted : March 15, 2018
Last Update Posted : August 19, 2019
AlphaMedix™ (²¹²Pb-DOTAMTATE) is a radiotherapeutic drug indicated in subjects with unresectable, metastatic somatostatin receptor (SSTR) positive neuroendocrine tumors (NETs). Because 212Pb is an in vivo generator of alpha particles, it is particularly suitable for SSTR therapy applications.
This drug addresses an unmet need in the field of peptide receptor radionuclide therapy (PRRT) for NETs. Substitution of an alpha emitter (²¹²Pb) for the beta emitters currently being used (i.e., 177Lu or 90Y) will provide significantly higher Linear Energy Transfer (LET) and a shorter path length. Higher LET particles should cause more tumor cell death. Shorter path length should result in less collateral damage of the normal tissue and therefore less side effects for subjects receiving the drug.
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumor||Drug: AlphaMedix||Phase 1|
This dose escalation study will include a maximum of 50 subjects with histologically confirmed NET, a positive somatostatin analogue scan, and no prior history of PRRT therapy.
The study will begin with a single ascending dose (SAD) of AlphaMedix™ administered by IV. Subsequent cohorts will receive an incremental 30% increase that will continue until tumor response or DLT. Once tumor response is observed, the study will convert to a Multiple Ascending Dose (MAD) regimen. The MAD treatment regimen will start with the previous safe cohort's dose and will consist of 3 IV administrations of AlphaMedix™ at 8-week intervals. Subsequent cohorts will receive an incremental 30% increase that will continue until tumor response or DLT.
The primary objective is to assess the safety and dose limiting toxicity (DLT) using ascending doses of AlphaMedix™. The secondary objectives are to determine the pharmacokinetic properties and preliminary effectiveness of AlphaMedix™.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Non-Randomized, Open-Label, Dose Escalation, Single-Center Study to Determine the Safety, Bio-distribution, and Preliminary Effectiveness of AlphaMedix™ in Adult Subjects With SSRT(+) NETs.|
|Actual Study Start Date :||February 5, 2018|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||November 2021|
There is only a single treatment arm.
There is only a single treatment intervention.
- To determine dose-limiting toxicity (DLT) [ Time Frame: 8 weeks ]DLT is defined as non-hematological toxicity - all Grade 4 and Grade 3 (except alk. phos.) that is not responsive to NMT 72 hours of supportive care - and all hematological toxicity that does not recover to NMT than Grade 2 within 8 wks of dose administration.
- To determine the maximum tolerated dose (MTD) [ Time Frame: 8 weeks ]The MTD is the dose level below that which 2 out of 6 subjects in a cohort have DLT.
- Partial or complete response assessed by modified RECIST v1.1 [ Time Frame: 8 weeks after injection ]CT/MRI or 18FDG-PET/CT (for patients who are FDG-avid at baseline) will be used to measure tumor size
- To determine effective blood clearance and cumulative blood activity of 212-Pb [ Time Frame: 24 hours ]Blood will be taken at Time 0, 1 hr, 4 hr and 24 hr post-injection and measured for activity in an auto gamma counter
- To determine the rate and extent of 212-Pb elimination in urine [ Time Frame: 24 hours ]Bladder will be emptied just prior to injection and qualitative urine collections will be done 0-1 hr, 1-4 hr and 4-24 hr post-injection and measured for activity in an auto gamma counter
- Incidence of treatment-related AEs and SAEs as assessed by CTCAE v. 4 [ Time Frame: 12 months ]AEs will be recorded both spontaneously by the patient and at all safety follow ups (2 wks, 4 wks, 6 wks, 8 wks post each injection and 3 mo, 6 mo, and 10 mo post last injection)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03466216
|United States, Texas|
|Excel Diagnostics and Nuclear Oncology Center|
|Houston, Texas, United States, 77042|
|Principal Investigator:||Rodolfo Nunez, MD||Excel Diagnostics and Nuclear Oncology Center|