Anti-CD38 Antibody Drug for Advanced Cancer

Overseen By Mike Royal, MD JD MBA

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Sorrento Therapeutics, Inc.

Must not be taking: Anti-CD38, CYP3A4 inhibitors

Disqualifiers: Other malignancies, Brain metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Variable, based on patient response

34 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is a Phase 1b, single-center, open-label, dose-finding trial designed to identify the Recommended Phase 2 Dose (RP2D) of STI 6129 by assessing the safety, preliminary efficacy, and immunogenicity in subjects with any advanced solid tumor. The patients that will be treated with STI-6129 in this trial are advanced solid tumor patients who have received prior lines of treatment.

Will I have to stop taking my current medications?

The trial requires that you stop using systemic anti-tumor therapy or investigational drugs within a certain period before starting the study drug. Additionally, you cannot take certain medications that affect specific liver enzymes during the study. Please discuss your current medications with the trial team to see if they are affected.

What data supports the effectiveness of the anti-CD38 antibody drug STI-6129 for advanced cancer?

Research shows that CD38-targeting antibodies, like STI-6129, can enhance the body's immune response against tumors by eliminating certain immune suppressor cells and improving T cell activity. These antibodies have shown effectiveness in treating multiple myeloma and have potential when combined with other cancer drugs, suggesting they might also be effective for advanced cancers. ^{1 2 3 4 5}

Is the anti-CD38 antibody drug generally safe for humans?

Research on CD38-targeting antibodies, like TAK-079, shows they have a favorable safety profile, meaning they are generally well-tolerated in humans. These antibodies have been studied in various conditions, including multiple myeloma, and have shown manageable side effects. ^{1 2 3 4 5}

How is the anti-CD38 antibody drug STI-6129 unique for treating advanced cancer?

STI-6129 is unique because it targets the CD38 molecule, which is present on many cancer cells, and works by enhancing the immune system's ability to attack these cells. This approach is different from traditional chemotherapy as it specifically targets cancer cells with CD38, potentially leading to fewer side effects and improved effectiveness in certain cancers. ^{1 2 3 5 6}

Eligibility Criteria

This trial is for adults with advanced solid tumors who have tried other treatments without success. They must have good blood, kidney, and liver function, be able to follow the study plan, use contraception if needed, and not have had certain severe health issues or recent anti-CD38 treatment.

Inclusion Criteria

My cancer is one of the specified types and has not responded to standard treatments.

Willingness to comply with study schedule and protocol requirements

Willingness to follow contraception guidelines

Exclusion Criteria

I haven't had any other cancer treatments in the last 3 years.

I have brain metastases or CNS disease that hasn't been treated or is causing symptoms.

I have not recently used any cancer drugs or been part of a drug trial.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive repeated 4-week cycles of STI-6129 via intravenous infusion

Variable, based on patient response

1 visit per 4-week cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 24 months

Treatment Details

Interventions

• STI-6129

Trial Overview The trial tests STI-6129 in patients with advanced solid tumors to find a safe dose and see how well it works. It's an early-phase study (Phase 1b) that looks at safety, effectiveness against cancer, and immune response.

Participant Groups

Group I: STI-6129 infusion Experimental Treatment 1 Intervention

Intravenous infusion to be given with prophylaxis for infusion reactions if necessary.

Who Is Running the Clinical Trial?

Sorrento Therapeutics, Inc.

Lead Sponsor

Trials

48

Recruited

2,000+

Findings from Research

CD38 is a promising target for antibody therapy in various lymphoid tumors, including multiple myeloma, due to its strong presence on tumor cell surfaces.

Recent advancements in anti-CD38 antibodies have shown potent cytolytic effects against myeloma cells, with some antibodies also inhibiting CD38's cyclase activity, enhancing their therapeutic potential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CD38 as a therapeutic target. Stevenson, GT.[2018]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Immunomodulatory effects of CD38-targeting antibodies. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Reprint of "Immunomodulatory effects of CD38-targeting antibodies". [2019]

3. England pubmed.ncbi.nlm.nih.gov

CD38 as a therapeutic target. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Targeting CD38 and PD-1 with isatuximab plus cemiplimab in patients with advanced solid malignancies: results from a phase I/II open-label, multicenter study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Safety, tolerability, pharmacokinetics and pharmacodynamics of the anti-CD38 cytolytic antibody TAK-079 in healthy subjects. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

CD38 antibodies in multiple myeloma: back to the future. [2021]