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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

Must not have

Treatment with an allogeneic hematopoietic stem cell transplantation (HSCT) within 6 months prior to the planned infusion of STI-6129, or active graft-versus-host disease (GVHD) following the allogeneic transplant, or a requirement for currently receiving immunosuppressive therapy following the allogeneic transplant

Presence of non-AL amyloidosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through study completion at up to 14 months

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I can take care of myself and am up and about more than half of my waking hours.

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I am capable of becoming pregnant and have had 2 negative pregnancy tests.

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My diagnosis of AL amyloidosis was confirmed by a biopsy.

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My AL amyloidosis has returned or didn't respond to treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had a stem cell transplant from a donor within the last 6 months, have GVHD, or am on immunosuppressants after the transplant.

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My condition is non-AL amyloidosis.

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My amyloidosis is localized to my bone marrow, blood vessels, or a single area of soft tissue.

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My AL amyloidosis is considered stage 4 or higher.

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My heart's left ventricle wall is thick without high blood pressure or heart valve disease.

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I have not had any infections 3 days before receiving STI-6129 treatment.

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I have been diagnosed with multiple myeloma.

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My heart condition limits my physical activity significantly.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through study completion at up to 14 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and tolerability of STI-6129 in AL amyloidosis patients

Secondary study objectives

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

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