IBI3020 for Cancer

Recruiting at 8 trial locations

Overseen By Serena Dong

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.

Must not be taking: CYP3A4 inhibitors

Disqualifiers: CNS metastases, Uncontrolled diseases, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 21 days for initial dose limiting toxicity assessment

285 Participants Needed

Trial Summary

What is the purpose of this trial?

The main purpose of this study is to evaluate the safety and tolerability of IBI3020 and to determine the maximum tolerated dose (MTD) and/or the recommended dose for expansion (RP2D) of IBI3020.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but it does mention that you should not have taken potent CYP3A4 inhibitors within 2 weeks before starting the study drug. It's best to discuss your current medications with the study team.

What safety data exists for IBI3020 or similar treatments?

The safety data for immune checkpoint inhibitors, which are similar to IBI3020, show that they can cause immune-related side effects like diarrhea, colitis (inflammation of the colon), and other organ-related issues. These side effects can range from mild to severe, and up to 50% of patients may experience them. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for individuals with solid tumors that cannot be removed by surgery or have spread widely (metastatic), including uterine tumors. Specific eligibility details are not provided, but typically participants must meet certain health standards and may need to have tried other treatments first.

Inclusion Criteria

Participants must have the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol

I have a tumor that can be measured by scans.

Minimum life expectancy of 12 weeks

Exclusion Criteria

Known allergies, hypersensitivity, or intolerance to IBI3020 or its excipients (refer to Investigator's Brochure)

I have been treated with specific targeted cancer therapies before.

Participating in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of an interventional study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive IBI3020 to evaluate safety, tolerability, and determine the maximum tolerated dose (MTD) and/or recommended dose for expansion (RP2D)

Up to 21 days for initial dose limiting toxicity assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and clinically significant changes in various health parameters

Up to 3 years

Treatment Details

Interventions

• IBI3020

Trial Overview The study focuses on IBI3020 as a potential treatment for these advanced solid tumors. It aims to find out the highest dose patients can take without serious side effects (MTD) and suggest a dose for further research (RP2D).

Participant Groups

Group I: IBI3020 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.

Lead Sponsor

Fortvita Biologics (USA)Inc.

Industry Sponsor

Trials

1

Recruited

80+

Findings from Research

A large-scale analysis of 16,196 serious adverse drug reaction reports identified 36 potential safety signals associated with ibrutinib, including ischemic heart diseases and fractures, highlighting the need for careful patient monitoring.

The study found that over half of the reports resulted in hospitalization, indicating that while ibrutinib is a standard treatment for B-cell malignancies, its safety profile requires further investigation to confirm these findings in broader populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Profile of Ibrutinib: An Analysis of the WHO Pharmacovigilance Database. Allouchery, M., Tomowiak, C., Lombard, T., et al.[2021]

Immune checkpoint inhibitors (ICIs) have significantly improved treatment outcomes for non-small cell lung cancer (NSCLC), offering durable benefits for some patients.

However, these therapies can lead to a range of immune-related adverse events (irAEs) that can affect multiple organ systems, highlighting the need for better understanding and prediction of these toxicities to improve patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immune checkpoint inhibitor-associated toxicity in advanced non-small cell lung cancer: An updated understanding of risk factors. Hu, X., Wang, L., Shang, B., et al.[2023]

In a review of 52 randomized controlled trials involving 23,322 patients with non-small cell lung cancer (NSCLC), the incidence of serious adverse events (AEs) was found to be similar between immune monotherapy and chemotherapy, with serious AEs occurring in about 33-48% of patients depending on the treatment type.

Certain immune-related adverse events (irAEs), such as colitis, pneumonitis, and rash, were more common in immunotherapy groups compared to chemotherapy, and interestingly, the occurrence of serious AEs like hepatitis and pneumonitis was positively correlated with better progression-free survival in patients receiving PD1 and PDL1 therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of immunotherapy in non-small cell lung cancer: A systematic review and network meta-analysis. Zhou, C., Li, M., Wang, Z., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

The risk of diarrhea and colitis in patients with lung cancer treated with immune checkpoint inhibitors: a systematic review and meta-analysis. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Safety Profile of Ibrutinib: An Analysis of the WHO Pharmacovigilance Database. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Immune checkpoint inhibitor-associated toxicity in advanced non-small cell lung cancer: An updated understanding of risk factors. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Adverse events of immunotherapy in non-small cell lung cancer: A systematic review and network meta-analysis. [2022]

5. Singapore pubmed.ncbi.nlm.nih.gov

Meta-analysis of immune-related adverse events of immune checkpoint inhibitor therapy in cancer patients. [2021]