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?

This trial tests a new cancer treatment called IBI3020, an experimental therapy, to determine its safety and optimal dosage. It targets individuals with advanced or metastatic solid tumors who have not responded to other treatments or experienced adverse side effects. Participants must have at least one measurable tumor and maintain a good level of daily activity. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in humans.

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.

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

Research has shown that IBI3020 was safe in early animal tests. These studies found that any side effects were expected and not severe. As the trial for IBI3020 begins with human participants, researchers are closely monitoring its tolerability.

Although there is limited information about its safety in humans, early results are encouraging. They suggest that IBI3020 might be safe enough for further testing. However, like other similar treatments, it could cause side effects, such as immune system issues, diarrhea, or colon inflammation. Participants should consider these possibilities when deciding to join the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about IBI3020 because it offers a new approach to treating cancer by targeting specific pathways in cancer cells that current treatments might not address. Unlike traditional chemotherapies that attack all rapidly dividing cells, IBI3020 is designed to selectively target cancerous cells, potentially reducing side effects. This selective mechanism could lead to more effective cancer control with a better safety profile, making it a promising option for patients and doctors alike.

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

Research has shown that IBI3020, the treatment under study in this trial, has been effective in fighting tumors in early lab studies. These studies used various methods and found that the treatment can successfully target and shrink tumors. This suggests that IBI3020 might help treat certain types of cancer. However, it is important to note that this information comes primarily from early lab research. More studies involving people are needed to confirm these results. ^{1 2 4 6 7}

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. 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 ( ...