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Antibody-Drug Conjugate
STI-6129 for Amyloidosis
Phase 1 & 2
Recruiting
Led By Suzanne Lentzsch, MD
Research Sponsored by Sorrento Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status of 0, 1, or 2
Females of childbearing potential (FCBP) must have 2 negative pregnancy tests prior to treatment. All heterosexually active FCBP and all heterosexually active male patients must agree to use effective methods of birth control throughout the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through study completion at up to 14 months
Awards & highlights
Study Summary
This trial is designed to find the best dose of STI-6129 to treat relapsed or refractory systemic AL amyloidosis while also assessing its safety and preliminary efficacy.
Who is the study for?
This trial is for adults with relapsed or refractory systemic AL amyloidosis who've had prior treatments. They must have measurable disease, be able to perform daily activities with minimal assistance (ECOG 0-2), and not be pregnant or breastfeeding. Participants should agree to use birth control and cannot have severe heart issues, certain infections like HIV/HBV/HCV, other recent cancers, or poor organ function.Check my eligibility
What is being tested?
The study tests STI-6129, an antibody-drug conjugate targeting CD38 in patients with AL amyloidosis that has come back or didn't respond to treatment. It's a multi-stage trial aiming to find the safest and most effective dose by observing how well it works and how the body processes it.See study design
What are the potential side effects?
Potential side effects of STI-6129 are not explicitly listed but may include reactions related to immune system activation against cancer cells, infusion-related responses, impact on blood counts and organ functions based on its mechanism as an antibody-drug conjugate.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I am capable of becoming pregnant and have had 2 negative pregnancy tests.
Select...
My diagnosis of AL amyloidosis was confirmed by a biopsy.
Select...
My AL amyloidosis has returned or didn't respond to treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through study completion at up to 14 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through study completion at up to 14 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and tolerability of STI-6129 in AL amyloidosis patients
Secondary outcome measures
Correlation of treatment response (organ responses and hematological response) with disease severity based on the 2012 revised Mayo Clinic staging system for AL amyloidosis
Organ response rates (cardiac, renal, hepatic, peripheral nervous system) according to the 2012 Consensus Round Table response criteria
Overall hematological response rate according to the 2012 Consensus Round Table response criteria
+1 moreSide effects data
From 2021 Phase 1 & 2 trial • 331 Patients • NCT0225756767%
FATIGUE
50%
ALOPECIA
50%
DECREASED APPETITE
50%
CONSTIPATION
50%
NAUSEA
50%
INSOMNIA
33%
HYPOPHOSPHATAEMIA
33%
RASH
33%
NEUTROPENIA
33%
VOMITING
33%
NIGHT SWEATS
33%
DIARRHOEA
33%
WEIGHT DECREASED
33%
HYPERGLYCAEMIA
33%
DYSPNOEA
17%
PLATELET COUNT DECREASED
17%
PRURITUS
17%
ARTHROPOD BITE
17%
SKIN DISCOLOURATION
17%
THROMBOCYTOPENIA
17%
HYPERTENSION
17%
GLAUCOMA
17%
STOMATITIS
17%
CHILLS
17%
FOLLICULITIS
17%
BONE PAIN
17%
HERPES ZOSTER
17%
INFUSION RELATED REACTION
17%
LYMPHOCYTE COUNT DECREASED
17%
HYPOMAGNESAEMIA
17%
HYPOKALAEMIA
17%
NEUROPATHY PERIPHERAL
17%
PERIPHERAL SENSORY NEUROPATHY
17%
EYE PRURITUS
17%
VISION BLURRED
17%
FLATULENCE
17%
SINUSITIS
17%
ENDOMETRIAL ADENOCARCINOMA
17%
ENDOMETRIAL CANCER
17%
ANAEMIA
17%
ABDOMINAL PAIN
17%
MUSCULAR WEAKNESS
17%
COUGH
17%
DYSPNOEA EXERTIONAL
17%
DRY SKIN
17%
MOUTH ULCERATION
17%
PALLOR
17%
EYE DISCHARGE
17%
VITAMIN D DEFICIENCY
17%
SINUS CONGESTION
17%
ATRIAL FIBRILLATION
17%
PYREXIA
17%
DIZZINESS
17%
PERIPHERAL SWELLING
17%
HODGKIN'S DISEASE
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL
Arm A (Phase II Randomization): Pola+BR in FL
Arm B (Phase II Randomization): BR in FL
Arm C (Phase II Randomization): Pola+BR in DLBCL
Arm D (Phase II Randomization): BR in DLBCL
Arm E (Phase II Expansion): Pola+BG in FL
Arm F (Phase II Expansion): Pola+BG in DLBCL
Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL
Trial Design
1Treatment groups
Experimental Treatment
Group I: STI-6129 infusionExperimental Treatment1 Intervention
Intravenous infusion to be given with prophylaxis for infusion reactions if necessary.
Find a Location
Who is running the clinical trial?
Sorrento Therapeutics, Inc.Lead Sponsor
47 Previous Clinical Trials
1,904 Total Patients Enrolled
1 Trials studying Amyloidosis
Suzanne Lentzsch, MDPrincipal InvestigatorColumbia University
1 Previous Clinical Trials
60 Total Patients Enrolled
Jeffrey Zonder, MDPrincipal InvestigatorBarbara Ann Karmanos Cancer Institute Wertz Clinic
2 Previous Clinical Trials
63 Total Patients Enrolled
1 Trials studying Amyloidosis
40 Patients Enrolled for Amyloidosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself and am up and about more than half of my waking hours.Your oxygen level is at least 92% when measured with a pulse oximeter while breathing room air.You have a specific type of measurable disease that can be detected through a blood test called serum-free light chain assay.Your heart is not pumping enough blood.Your blood tests show abnormal results before starting the study.I had a stem cell transplant from a donor within the last 6 months, have GVHD, or am on immunosuppressants after the transplant.I am capable of becoming pregnant and have had 2 negative pregnancy tests.My condition is non-AL amyloidosis.My amyloidosis is localized to my bone marrow, blood vessels, or a single area of soft tissue.My AL amyloidosis is considered stage 4 or higher.My diagnosis of AL amyloidosis was confirmed by a biopsy.Your blood test results are not normal before starting the study.My heart's left ventricle wall is thick without high blood pressure or heart valve disease.I haven't had any other cancers in the last 3 years, or if I have, they are in complete remission.My AL amyloidosis has returned or didn't respond to treatment.Your heart's electrical activity takes longer than usual to reset itself.I have not had any infections 3 days before receiving STI-6129 treatment.I have been diagnosed with multiple myeloma.I have HIV, HTLV1, HBV, or HCV, or am at risk for HBV reactivation.My heart condition limits my physical activity significantly.You have a specific protein in your blood called a monoclonal light chain.Your NT-proBNP level is higher than 1800 ng/L or your BNP level is higher than 400 ng/L.
Research Study Groups:
This trial has the following groups:- Group 1: STI-6129 infusion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
At how many sites is this clinical experiment taking place?
"This clinical trial is administered through Barbara Ann Karmanos Cancer Institute Wertz Clinic in Detroit, Michigan, Boston Medical Center in Boston, Massachusetts and City of Hope National Medical Center in Duarte, California alongside 5 additional medical centres."
Answered by AI
What is the sample size of this clinical trial?
"To successfully administer this drug trial, Sorrento Therapeutics, Inc. requires the enrollment of 60 qualified patients from multiple locations including Barbara Ann Karmanos Cancer Institute Wertz Clinic in Detroit and Boston Medical Center in Massachusetts."
Answered by AI
Is recruitment for this trial still in progress?
"Yes, the information on clinicaltrials.gov attests that this research is actively recruiting participants. It was initially listed on February 25th 2021 and updated most recently on September 7th 2022; 60 patients need to be recruited across 5 medical centres."
Answered by AI
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