IBI3020 for Cancer

Recruiting at 10 trial locations

Overseen By Jinming Sun

Age: 18+

Sex: Any

Trial Phase: Phase 1

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

Must not be taking: CYP3A4 inhibitors, Live vaccines

Disqualifiers: CNS metastases, Lung 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

What You Need to Know Before You Apply

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 must stop taking your current medications, but it mentions a washout period (time without taking certain medications) for prior anti-cancer therapy and potent CYP3A4 inhibitors. It's best to discuss your current medications with the trial team.

What safety data exists for IBI3020 or similar treatments?

The research articles discuss immune checkpoint inhibitors, which are similar to IBI3020, and highlight that these treatments can cause immune-related side effects like diarrhea, colitis (inflammation of the colon), and other organ damage. These side effects can range from mild to severe, affecting the heart, lungs, digestive system, hormone glands, and skin. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for individuals with advanced solid tumors, including those in the uterus. Participants should meet specific health criteria and not have conditions that could interfere with the study or pose additional risks.

Inclusion Criteria

Participants 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

At least 1 measurable lesion as defined per RECIST v1.1 within 28 days prior to the first dose of IBI3020

Minimum life expectancy of 12 weeks

Exclusion Criteria

Known allergies, hypersensitivity, or intolerance to IBI3020 or its excipients

Under neurological, psychiatric or social condition

Women who are pregnant, have positive results in pregnancy test or are lactating

Timeline for a Trial Participant

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 the 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 assessments of physical examination, electrocardiogram, vital signs, and laboratory parameters

Up to 3 years

Long-term follow-up

Participants are monitored for long-term outcomes such as overall survival and progression-free survival

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• IBI3020

Trial Overview The focus of this study is IBI3020, a new treatment for late-stage solid tumors. The goal is to find out how much can be given safely (MTD) and what's an effective dose (RP2D).

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

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]