IBI3020 for Cancer

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called IBI3020 to assess its safety and tolerability in individuals with certain advanced solid tumors that cannot be surgically removed. The main goal is to determine the highest dose patients can tolerate without serious side effects. The trial seeks participants with a confirmed diagnosis of unresectable, locally advanced, or metastatic solid tumors and at least one measurable tumor. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.

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.

Is there any evidence suggesting that IBI3020 is likely to be safe for humans?

Research has shown that IBI3020 has a good safety record in early animal studies, indicating it was generally well-tolerated. This treatment resembles other drugs that can sometimes cause immune-related side effects, such as diarrhea or inflammation of the colon in people. However, researchers are still studying IBI3020 to find the safest dose. As this is a Phase 1 trial, the primary goal is to assess the treatment's safety in humans and determine the correct dosage. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about IBI3020 because it offers a novel approach to treating cancer. Unlike traditional treatments that often rely on chemotherapy or radiation, which can be harsh on the body, IBI3020 may work through a unique mechanism of action that specifically targets cancer cells while sparing healthy tissue. This targeted action could potentially lead to fewer side effects and improved outcomes for patients. Additionally, if IBI3020 can effectively zero in on cancer cells, it might offer a more personalized treatment option, which is a significant step forward in cancer therapy.

What evidence suggests that IBI3020 might be an effective treatment for cancer?

Research has shown that IBI3020, the treatment under study in this trial, demonstrates promising cancer-fighting abilities in early lab studies. These studies, conducted in a controlled environment, found IBI3020 effective in slowing tumor growth by targeting specific cancer cells. Although information from human trials remains limited, these early results suggest potential effectiveness for certain cancer types. As research progresses, scientists aim to confirm these findings in people. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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 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 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

What Are the Treatments Tested in This Trial?

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).

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. clinicaltrials.gov clinicaltrials.gov/study/NCT06963281

NCT06963281 | Study of IBI3020 Treatment in Participants ... 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 ...

2. prnewswire.com prnewswire.com/news-releases/innovent-announces-first-patient-dosed-in-phase-1-study-of-ibi3020-global-first-in-class-dual-payload-ceacam5-adc--in-patients-with-advanced-malignancies-302441146.html

Innovent Announces First Patient Dosed in Phase 1 Study ... The study is an open-label, multi-regional Phase 1 study evaluating the safety, tolerability, and preliminary efficacy of IBI3020 in participants with advanced ...

3. synapse.patsnap.com synapse.patsnap.com/article/innovent-doses-first-patient-in-phase-1-study-of-ibi3020-for-advanced-cancers

Innovent Doses First Patient in Phase 1 Study of IBI3020 ... In preclinical settings, IBI3020 has shown significant antitumor activity across various pharmacological models, including a noteworthy ...

4. trial.medpath.com trial.medpath.com/clinical-trial/79c2eba3a071d56a/nct06946446-ibi3020-treatment-solid-tumors

Study of IBI3020 Treatment in Participants With Unresectable ... 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...

5. investor.innoventbio.com investor.innoventbio.com/media/1325/innovent-biologics_2025-semi-annual-results_website.pdf

Innovent Biologics 2025 Interim Results ... Data Reflects Strong Immune Activation and. Tailing Effect of IO Therapy. References of the SoC data are results from clinical trials TROPION-LUNG, FRESCO and ...

6. ctv.veeva.com ctv.veeva.com/study/study-of-ibi3020-treatment-in-participants-with-unresectable-locally-advanced-or-metastatic-solid-t

Study of IBI3020 Treatment in Participants With Unresectable ... The main purpose of this study is to evaluate the safety and tolerability of IBI3020 and to determine the maximum tolerated dose (MTD) ...

7. withpower.com withpower.com/trial/phase-1-neoplasms-4-2025-f19be

IBI3020 for Cancer · Info for Participants The safety data for immune checkpoint inhibitors, which are similar to IBI3020, show that they can cause immune-related side effects like diarrhea, colitis ( ...