What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, such as antibody-drug conjugates (ADCs), proteasome inhibitors, immunomodulatory drugs, and monoclonal antibodies, have a range of side effects. ADCs like belantamab mafodotin can cause ocular toxicity, thrombocytopenia, and infusion-related reactions. Proteasome inhibitors such as bortezomib and carfilzomib often lead to peripheral neuropathy, gastrointestinal issues, and increased risk of infections. Immunomodulatory drugs like lenalidomide and pomalidomide are associated with myelosuppression, thromboembolic events, and fatigue. Monoclonal antibodies, including daratumumab, can cause infusion reactions, respiratory infections, and cytopenias. These side effects vary in severity and frequency, necessitating careful monitoring and management.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Multiple Myeloma that are similar to STI-6129. These include antibody-drug conjugates like belantamab mafodotin, which targets BCMA on myeloma cells. Additionally, small molecule inhibitors such as proteasome inhibitors (e.g., bortezomib, carfilzomib) and immunomodulatory drugs (e.g., lenalidomide, pomalidomide) have been approved. These treatments work by targeting specific pathways or proteins involved in the survival and proliferation of myeloma cells.

What other types of research exist?

Promising novel alternatives to STI-6129 for Multiple Myeloma patients include: <ol> <li>Daratumumab (an anti-CD38 monoclonal antibody) in combination with other agents like CyBorD (cyclophosphamide, bortezomib, and dexamethasone).</li> <li></li> </ol> Venetoclax (a BCL-2 inhibitor) particularly for patients with t(11;14) translocation. 3. CAR T-cell therapies targeting BCMA (B-cell maturation antigen), such as idecabtagene vicleucel and ciltacabtagene autoleucel. 4. Bispecific T-cell engagers (BiTEs) like teclistamab, which targets BCMA and CD3. 5. Selinexor (a selective inhibitor of nuclear export) in combination regimens. These therapies have shown significant promise in clinical trials and are expected to be important options for Multiple Myeloma treatment in 2024.

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Monoclonal Antibodies

Anti-CD38 Antibody Drug (STI-6129) for Multiple Myeloma

Phase 1 & 2

Waitlist Available

Led By David Kaminetzky, 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

Eastern Cooperative Oncology Group (ECOG) performance of 0 - 2

Must have relapsed or refractory multiple myeloma (RRMM) after having received prior lines of anti-myeloma treatments, including being refractory to a proteasome inhibitor, immunomodulatory agent and an anti-CD38 monoclonal antibody

Must not have

Prior treatment with allogeneic hematopoietic stem cell transplantation within 6 months, active graft versus host disease following transplant, or currently receiving immunosuppressive therapy following transplant

Known HIV or acquired immunodeficiency syndrome-related illness, acute or history of chronic hepatitis B or C

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through study completion at up to approximately 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests STI-6129, a new drug for multiple myeloma patients whose cancer has returned or not responded to other treatments. The drug is given through an IV periodically to find the best dose and check its safety and effectiveness.

Who is the study for?

This trial is for adults with relapsed or refractory multiple myeloma who have tried other treatments, including a proteasome inhibitor and an anti-CD38 antibody. Participants must be in stable condition, able to perform daily activities (ECOG 0-2), and agree to use contraception. Excluded are those with significant heart issues, recent other cancers, severe infections like COVID-19 or hepatitis, certain blood disorders, or poor kidney function.

What is being tested?

The study tests STI-6129, an experimental drug given intravenously every four weeks to people whose multiple myeloma has not responded to standard treatments. It's a phase 1b/2a trial that gradually increases the dose of STI-6129 to find the safest and most effective level for patients.

What are the potential side effects?

Potential side effects of STI-6129 aren't detailed here but may include typical reactions related to immune therapies such as infusion-related symptoms (like fever or chills), fatigue, nausea, low blood counts increasing infection risk and possibly organ-specific inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to care for myself and perform daily activities.

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My multiple myeloma has returned or didn't respond to treatment including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.

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 less than 6 months ago, have graft versus host disease, or am on immunosuppressive therapy post-transplant.

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I have HIV/AIDS or chronic hepatitis B or C.

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I have severe muscle weakness or serious eye problems.

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My blood clotting tests are abnormal, but I am on a stable dose of blood thinner.

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I have severe nerve pain or damage.

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I do not have any ongoing infections.

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I have had cancer that needed treatment in the last 3 years or it's not fully in remission.

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I do not have any health or mental conditions that would stop me from joining the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through study completion at up to approximately 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through study completion at up to approximately 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through study completion at up to approximately 24 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 of STI-6129

Secondary study objectives

Assess preliminary efficacy

Measuring Pharmacokinetic [PK] Profile

Overall response and duration

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: STI-6129Experimental Treatment1 Intervention

Seven dosing cohorts will be evaluated: 0.67 mg/kg, 0.88 mg/kg, 1.18 mg/kg, 1.56 mg/kg, 2.08 mg/kg, 2.77 mg/kg, 3.68 mg/kg where STI-6129 will be intravenously administered once as part of a 4-week treatment cycle.

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Multiple Myeloma treatments primarily target the malignant plasma cells through various mechanisms. Proteasome inhibitors (e.g., bortezomib) disrupt protein degradation, leading to cell death. Immunomodulatory drugs (e.g., lenalidomide) enhance immune response and inhibit tumor growth. Monoclonal antibodies (e.g., daratumumab) target specific antigens on myeloma cells, marking them for immune destruction. Novel agents like antibody-drug conjugates (e.g., STI-6129) combine targeted antibodies with cytotoxic drugs to deliver lethal agents directly to cancer cells. These mechanisms are crucial as they offer targeted, effective treatments with potentially fewer side effects, improving patient outcomes and quality of life.

Experimental approaches in the treatment of multiple myeloma.Novel treatment approaches for patients with relapsed and refractory multiple myeloma.