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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, STI-6129 (an anti-CD38 antibody drug), to determine the right dose for treating advanced solid tumors such as lung, esophageal, head and neck cancers, and certain types of colorectal cancer. The trial aims to assess the drug's safety, effectiveness, and interaction with the body's immune system. It seeks participants who have previously tried other treatments for their advanced cancer and are still seeking options. Participants will receive the drug through an infusion, and the trial will closely monitor their response. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

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.

Is there any evidence suggesting that STI-6129 is likely to be safe for humans?

Research has shown that STI-6129 was tested for safety in earlier studies. These studies aimed to find the optimal dose that balances efficacy and safety. Researchers examined how STI-6129 behaves in the body and its effectiveness against cancer cells.

So far, these studies have not provided specific information on serious side effects. However, as this is a Phase 1 trial, the primary goal is to assess the treatment's safety, resulting in limited detailed safety data. The trial focuses on determining the right dose for future studies.

Prospective participants should know that researchers will closely monitor for any side effects to ensure safety and to gain insights into the treatment's effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

The experimental treatment STI-6129 is unique because it utilizes an anti-CD38 antibody that specifically targets CD38 proteins found on the surface of certain cancer cells. Unlike traditional chemotherapy, which can affect both healthy and cancerous cells, this approach aims to directly attack cancer cells, potentially resulting in fewer side effects. Researchers are excited about STI-6129 because it promises a more targeted treatment option, which could improve effectiveness and tolerability for patients with advanced cancer.

What evidence suggests that STI-6129 might be an effective treatment for advanced cancer?

Research has shown that STI-6129, the investigational treatment in this trial, yields promising results in treating tumors. Animal studies demonstrated its effectiveness by targeting CD38, a protein on cancer cells, allowing the drug to attack cancer cells while sparing healthy ones. Early human studies also suggest that STI-6129 can be safe and effective, but further research is needed to confirm these results in individuals with advanced solid tumors. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. ashpublications.org ashpublications.org/blood/article/138/Supplement%201/4763/481786/A-Phase-1-Open-Label-Dose-Escalation-Study-of-the

A Phase 1, Open-Label, Dose-Escalation Study of the Safety ... The phase 1 trial is designed to identify the recommended phase 2 dose (RP2D) of STI-6129 by assessing safety, preliminary efficacy, and pharmacokinetics.

2. aacrjournals.org aacrjournals.org/cancerres/article/80/16_Supplement/LB-227/645307/Abstract-LB-227-Preclinical-development-and

Preclinical development and characterization of STI-6129, an ... Further, the anti-tumor activity of STI-6129 showed broad, potent, and CD38-dependent in vivo efficacy in multiple xenograft animal models.

3. sciencedirect.com sciencedirect.com/science/article/pii/S000649712106660X

A Phase 1, Open-Label, Dose-Escalation Study of the ... The phase 1 trial is designed to identify the recommended phase 2 dose (RP2D) of STI-6129 by assessing safety, preliminary efficacy, and pharmacokinetics in ...

4. synapse.patsnap.com synapse.patsnap.com/article/advancements-in-multiple-myeloma-therapy-the-emergence-of-sti-6129-as-a-promising-anti-cd38-adc

The Emergence of STI-6129 as a Promising Anti-CD38 ADC STI-6129 has shown broad and potent in vivo anti-tumor efficacy in various xenograft models. Pharmacokinetic studies in Daudi-Fluc tumor-bearing ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05565807

Safety and Efficacy Study of An Anti-CD38 Antibody Drug ... This is a phase Ib/IIa, open-label, dose-escalation, and extension study to evaluate the safety and efficacy of an anti-CD38 antibody drug conjugate (STI-6129) ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04316442

Study of the Safety and Efficacy of STI-6129 in Patients ... It is designed primarily to identify the recommended phase 2 dose (RP2D) of STI-6129 by assessing the safety, preliminary efficacy and pharmacokinetics of this ...

7. mayo.edu mayo.edu/research/clinical-trials/cls-20537620

Study to Assess Anti-CD38 Antibody Drug Conjugate in ... The purpose of this trial is to identify the RP2D of STI-6129 by assessing the safety, preliminary effectiveness and pharmacokinetics in ...