YL211 for Cancer

Recruiting at 12 trial locations

Overseen By Sasha Stann

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.

Disqualifiers: Cardiovascular, Pulmonary, Infection, others

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

Compensation: Varies

Number of Visits: Unknown

155 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called YL211, a potential drug for patients with advanced solid tumors. The trial aims to determine the right dose and assess the treatment's safety and effectiveness. It consists of three parts: first, testing different dosages; second, further evaluating safety and effectiveness; and third, expanding to more patients. Individuals with advanced solid tumors who have not responded to other treatments might be suitable candidates. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

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 mentions an 'inadequate washout period' for prior anticancer treatment as an exclusion criterion. This suggests that you may need to stop certain anticancer treatments before starting the trial.

Is there any evidence suggesting that YL211 is likely to be safe for humans?

Research has shown that YL211 has been well-tolerated in early lab and animal studies. These studies found that YL211 helped shrink tumors without causing significant problems. However, since YL211 is now undergoing its first human trials, the researchers are still learning about its safety in people. This trial aims to find the safest dose for patients with advanced solid tumors. As an early-stage trial, the focus is on how the human body processes YL211 and identifying any side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about YL211 for cancer because it introduces a novel approach to treatment. Unlike many traditional cancer therapies that primarily target rapidly dividing cells, YL211 works by a unique mechanism that targets specific pathways involved in cancer cell growth and survival, potentially leading to more effective and targeted therapy. This specificity not only aims to enhance the treatment's efficacy but also to minimize the side effects commonly associated with conventional chemotherapy. Additionally, if YL211 proves effective, it could provide new hope for patients with cancers that are resistant to existing treatments.

What evidence suggests that YL211 might be an effective treatment for cancer?

Research has shown that YL211 could be a promising treatment for advanced solid tumors. Early studies suggest it might work well for cancers with a specific protein called cMET, which YL211 targets. This treatment attaches cancer-fighting drugs to antibodies, delivering the drugs directly to tumor cells. Initial results indicate that this method could help reduce tumor growth. Although human studies have provided limited information, these early signs are encouraging for those considering further research participation. Trial participants will engage in various phases, including dose-escalation, dose-expansion, and backfill enrollment, to further evaluate the effectiveness and safety of YL211. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with advanced solid tumors who have likely tried other treatments without success. Specific details about eligibility criteria are not provided, but typically participants must be adults in stable condition and able to comply with study requirements.

Inclusion Criteria

Informed of the trial before the start of the trial and voluntarily sign their name and date on the ICF

Be able and willing to comply with protocol visits and procedures

Have at least 1 extracranial measurable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Exclusion Criteria

I haven't had a long enough break from my last cancer treatment before starting the study drug.

I have a serious lung condition besides my cancer.

I still have side effects from past cancer treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-Escalation

Safety and tolerability of YL211 are evaluated to determine the maximum tolerated dose (MTD) and recommended expansion dose (RED)

Approximately 12 months

Backfill Enrollment

Further estimation of safety and efficacy of YL211 to select the RED(s)

Approximately 12 months

Dose-Expansion

Evaluation of safety and efficacy of YL211 at the MTD/RED(s) in patients with advanced solid tumors

Approximately 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• YL211

Trial Overview YL211 is being tested in this Phase I trial. It's given intravenously to patients with advanced solid tumors across three parts: dose-escalation to find the maximum tolerated dose (MTD), backfill enrollment to confirm safety and efficacy, and dose-expansion at MTD to further assess its effects.

How Is the Trial Designed?

Group I: Part 3: Dose-Expansion Part Experimental Treatment 1 Intervention

Dose-Expansion Part

Group II: Part 2: Backfill Enrollment Part Experimental Treatment 1 Intervention

Backfill Enrollment Part

Group III: Part 1: Dose-Escalation Part Experimental Treatment 1 Intervention

Dose-Escalation Part

Who Is Running the Clinical Trial?

MediLink Therapeutics (Suzhou) Co., Ltd.

Lead Sponsor

Trials

12

Recruited

3,400+

Hoffmann-La Roche

Industry Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Published Research Related to This Trial

Cytoplasmic Y-box-binding protein 1 (YB1) is linked to more aggressive breast cancer characteristics, such as higher nuclear grade and the presence of breast cancer stem cells, indicating a potential role in tumor progression.

Nuclear YB1 expression is associated with poorer disease-free survival in breast cancer patients, particularly those receiving chemotherapy and radiotherapy, suggesting it could be a prognostic marker for recurrence risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Y-box-binding protein 1 (YB1) in breast carcinomas: relation to aggressive tumor phenotype and identification of patients at high risk for relapse. Mylona, E., Melissaris, S., Giannopoulou, I., et al.[2016]

Y box-binding protein 1 (YB-1) levels are significantly higher in breast cancer tissues and certain breast cancer cell lines compared to normal breast tissues, suggesting its role in breast cancer proliferation.

Manipulating YB-1 levels in SK-BR-3 breast cancer cells shows that reducing YB-1 decreases cell proliferation, while increasing YB-1 promotes it, indicating that YB-1 may be a potential target for breast cancer therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Roles of Y box-binding protein 1 in SK-BR-3 breast cancer proliferation]. Shi, J., Lü, X., Wang, B., et al.[2018]

YY1 can effectively suppress the growth of various tumor cell types, including human breast carcinoma and glioblastoma cells, as demonstrated in vitro.

In a rat model, YY1 reduced the growth of mammary adenocarcinoma tumors by approximately 80% over 21 days, indicating its potential as a therapeutic agent against certain cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yin Yang-1 inhibits tumor cell growth and inhibits p21WAF1/Cip1 complex formation with cdk4 and cyclin D1. Ishii, H., Hulett, MD., Li, JM., et al.[2012]

Y-box binding protein-1 (YB-1) is linked to poor prognosis in breast cancer by promoting the expression of cancer stem cell markers CD44 and CD49f, which enhances cancer cell growth and drug resistance.

Targeting YB-1 can sensitize breast cancer cells, particularly those with high CD44 and low CD24 expression, to the chemotherapy drug paclitaxel, suggesting a potential therapeutic strategy to overcome drug resistance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Y-box binding protein-1 induces the expression of CD44 and CD49f leading to enhanced self-renewal, mammosphere growth, and drug resistance. To, K., Fotovati, A., Reipas, KM., et al.[2022]

The YL-1 gene product significantly suppresses anchorage-independent growth in Kirsten sarcoma virus-transformed NIH3T3 cells, indicating its role as a transformation suppressor.

While YL-1 effectively inhibits colony formation in soft agar, it does not affect other transformed characteristics in adherent cultures or tumorigenicity in nude mice, suggesting its specific action on anchorage independence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Forced expression of YL-1 protein suppresses the anchorage-independent growth of Kirsten sarcoma virus-transformed NIH3T3 cells. Horikawa, I., Tanaka, H., Yuasa, Y., et al.[2009]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06384352

NCT06384352 | A Phase I Study to Evaluate the Safety, ... A Phase I Study to Evaluate the Safety,Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors. ClinicalTrials.gov ID ...

2. aacrjournals.org aacrjournals.org/cancerres/article/84/6_Supplement/2615/737306/Abstract-2615-Preclinical-development-of-a-next

Preclinical development of a next generation antibody drug ... Taken together, preclinical data suggest that YL211 could be a promising treatment strategy for cMET positive cancer patients. Citation ...

3. medicine.yale.edu medicine.yale.edu/ycci/clinicaltrials/trial/a-study-of-yl211-in-patients-with-advanced-solid-tumors/

YL211-INT-101-01: A Phase 1, Multicenter, Open-Label, First ... This is a multicenter, open-label, Phase 1 study. The study will enroll subjects with advanced solid tumors. It consists of three parts.

4. yalemedicine.org yalemedicine.org/clinical-trials/a-study-of-yl211-in-patients-with-advanced-solid-tumors

YL211-INT-101-01: A Phase 1, Multicenter, Open-Label ... This is a multicenter, open-label, Phase 1 study. The study will enroll subjects with advanced solid tumors. It consists of three parts.

5. trial.medpath.com trial.medpath.com/clinical-trial/9661685dc0e20027/nct06384352-safety-tolerability-pharmacokinetics-efficacy-yl211-advanced-solid-tumors

A Phase I Study to Evaluate the Safety,Tolerability ... - MedPath A Phase I study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of YL211 in patients with advanced solid tumors.

6. careacross.com careacross.com/clinical-trials/trial/NCT06384352

A Phase I Study to Evaluate the SafetyTolerability ... In part 1, the safety and tolerability of YL211 in patients with selected advanced solid tumors will be evaluated and the MTD and RED will be determined. Part 2 ...

7. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-07039

A Phase I Study to Evaluate the Safety,Tolerability ... We will further estimate the safety and efficacy of YL211 in patients with selected adcance tumor to select the RED(s) of YL211. Part 3 is dose-expansion ...

8. withpower.com withpower.com/trial/phase-1-neoplasms-4-2024-7ccb1

YL211 for Cancer · Recruiting Participants for Phase ... Safety and tolerability of YL211 are evaluated to determine the maximum tolerated dose (MTD) and recommended expansion dose (RED). Approximately 12 months.