YL217 for Cancer

Recruiting at 20 trial locations

Overseen By Angie Cao, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

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

Must not be taking: Topoisomerase inhibitors, Steroids

Disqualifiers: Cardiovascular, Pulmonary, HIV, Hepatitis C, others

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

Compensation: Varies

Number of Visits: Unknown

220 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called YL217, a potential drug for patients with advanced solid tumors, which are cancers that have spread and are difficult to remove surgically. The trial aims to determine a safe dose and assess its effectiveness. It consists of three parts: dose-finding, further testing, and dose confirmation. Eligible participants are those with an advanced solid tumor that cannot be surgically removed or has spread. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, providing participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, there is a requirement for an adequate washout period (time without taking certain medications) for prior anticancer treatments before starting the study drug.

Is there any evidence suggesting that YL217 is likely to be safe for humans?

Research has shown that YL217 was well tolerated by patients in earlier studies. YL217, a targeted cancer treatment, can slow tumor growth, with effects increasing at higher doses. Importantly, no severe side effects were reported, suggesting it may be safe for humans. However, as this is an early trial, the primary goal is to determine a safe dose, so the treatment's safety remains under close observation. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about YL217 because it offers a novel approach to treating cancer. Unlike many standard cancer treatments that target cancer cells broadly, YL217 is designed to precisely target specific pathways involved in cancer cell growth. This specificity could potentially lead to fewer side effects and more effective treatment outcomes. Additionally, YL217's ability to be administered at multiple dose levels allows for optimization and personalization of treatment, which is not always possible with existing therapies.

What evidence suggests that YL217 might be an effective treatment for cancer?

Research has shown that YL217 may help treat cancer by slowing tumor growth. In studies, participants generally tolerated the treatment well, and higher doses appeared more effective. In this trial, participants will receive YL217 in different phases: the Dose-Escalation Part to determine optimal doses, the backfill stage to test selected doses, and the Dose-Expansion Part to further support dose selection. YL217 combines an antibody with a drug to more accurately target cancer cells. It is primarily being developed for digestive system cancers, such as those in the colon, pancreas, and stomach. This treatment targets a specific protein linked to these cancers, offering a potentially effective option. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

Adults aged 18+ with advanced solid tumors, including certain gastrointestinal cancers, who can sign consent and follow study procedures. They must have at least one measurable tumor lesion, good organ function, and an ECOG performance status of 0 or 1. Those with HIV, recent major surgery, severe lung issues or specific prior treatments are excluded.

Inclusion Criteria

I have signed the informed consent form for this study.

Able and willing to comply with protocol visits and procedures

My organs and bone marrow are working well.

Exclusion Criteria

Concurrent enrollment in another clinical study, unless it is an observational clinical study

I have not had major surgery in the last 4 weeks and do not expect any during the study.

I am HIV positive.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of YL217 to determine the maximum tolerated dose

Up to 3 years

Backfill

Participants are enrolled at safe and tolerable dose levels determined in the dose escalation phase

Up to 3 years

Dose Expansion

Dose optimization is performed in disease-specific cohorts with random assignment to dose regimens

Up to 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• YL217

Trial Overview

The trial is testing YL217, a new drug given as an intravenous infusion every three weeks to patients with various advanced solid tumors. It's the first time this drug is being tested in humans to see how safe it is and how well it works.

How Is the Trial Designed?

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

Upon completion of Part 1 and Part 2 with determination of MTD/RDE(s), the dose-expansion part will be conducted to further support the RP2D selection.

Group II: Part 2: The backfill stage of YL217 Experimental Treatment 1 Intervention

Patients will be enrolled at one or more dose levels that do not exceed the dose that is deemed safe and tolerable in dose escalation. Then several dose levels will be selected as the recommended dose for expansion (RDE).

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

Participants will receive escalating doses of YL217 until doses for optimization are determined

Who Is Running the Clinical Trial?

MediLink Therapeutics (Suzhou) Co., Ltd.

Lead Sponsor

Trials

12

Recruited

3,400+

Published Research Related to This Trial

CD147 is a key protein overexpressed in various aggressive cancers, playing a crucial role in cancer growth, survival, and metastasis through multiple signaling pathways.

Targeting CD147 with therapies, such as monoclonal antibodies, has shown promise in enhancing treatment efficacy and reducing side effects in chemoradiotherapy and other cancer treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CD147: an integral and potential molecule to abrogate hallmarks of cancer. Nyalali, AMK., Leonard, AU., Xu, Y., et al.[2023]

Osimertinib significantly improves progression-free survival (PFS) in patients with metastatic non-small cell lung cancer (NSCLC) with the EGFR T790M mutation, showing a median PFS of 10.1 months compared to 4.4 months with chemotherapy in a trial of 419 patients.

The safety profile of osimertinib is favorable compared to other EGFR tyrosine kinase inhibitors and chemotherapy, with common side effects including diarrhea and rash, making it a viable treatment option for patients who have progressed on previous therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Benefit-Risk Assessment of Osimertinib for the Treatment of Metastatic Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor T790M Mutation. Odogwu, L., Mathieu, L., Goldberg, KB., et al.[2022]

In a phase II trial involving 30 patients with advanced non-squamous non-small cell lung cancer (NSCLC), the combination of apatinib and docetaxel resulted in a disease control rate of 96.6% and a partial remission rate of 27.6%.

The treatment was found to be tolerable, with most adverse events being mild to moderate (grade 1-2), including hypertension and hand-foot syndrome, indicating that apatinib plus docetaxel is a safe option for patients with wild-type EGFR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination of apatinib and docetaxel in treating advanced non-squamous non-small cell lung cancer patients with wild-type EGFR: a multi-center, phase II trial. Song, Y., Miao, L., Wang, Z., et al.[2022]

In a study of 78 BRAF inhibitor-naive patients with BRAF V600 mutation-positive metastatic melanoma treated with dabrafenib and trametinib, the median overall survival was over 2 years, with 72% of patients alive at 1 year and 47% at 3 years.

Approximately 20% of patients were progression-free at 3 years, with better outcomes associated with having fewer than three organ metastases and lower baseline lactate dehydrogenase levels, suggesting these factors may help predict durable responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overall Survival and Durable Responses in Patients With BRAF V600-Mutant Metastatic Melanoma Receiving Dabrafenib Combined With Trametinib. Long, GV., Weber, JS., Infante, JR., et al.[2022]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06859762

A First-in-Human Study of YL217 in Patients With ...

The results indicated that YL217 was well tolerated, and YL217 suppressed growth of established human tumors in a dose-dependent manner in cancer cells or ...

2.

medicine.yale.edu

medicine.yale.edu/ycci/clinicaltrials/trial/a-study-of-yl217-in-patients-with-advanced-and-solid-tumors/

A Phase 1, Multicenter, Open-Label, First-in-Human Study to ...

The results indicated that YL217 was well tolerated, and YL217 suppressed growth of established human tumors in a dose-dependent manner in ...

3.

ctv.veeva.com

ctv.veeva.com/study/a-first-in-human-study-of-yl217-in-patients-with-advanced-solid-tumors

A First-in-Human Study of YL217 in Patients With Advanced ...

The results indicated that YL217 was well tolerated, and YL217 suppressed growth of established human tumors in a dose-dependent manner in ...

4.

oncologypipeline.com

oncologypipeline.com/apexonco/cdh17-becomes-flavour-month

CDH17 becomes flavour of the month | ApexOnco

Targeting CDH17 is said to have utility in GI cancers, especially colorectal, pancreatic and gastric, though some groups also claim CDH17 ...

5.

medilinkthera.com

medilinkthera.com/news-details/46

MediLink's YL217 received FDA Clearance of IND ...

YL217 is an antibody-drug-conjugate with a novel target, primarily developed for gastrointestinal tumors. The targeted protein is specifically ...

6.

aacrjournals.org

aacrjournals.org/cancerres/article/85/8_Supplement_1/2940/755637/Abstract-2940-Preclinical-development-of-a-next

Preclinical development of a next generation antibody drug ...

Taken together, preclinical data suggest that YL217 could be further developed in the treatment of CDH17-positive cancer patients. Citation ...

7.

delta.larvol.com

delta.larvol.com/Products/?ProductId=bddca2e7-8f83-47fe-99ef-7737416af65f

YL217 / MediLink

Taken together, preclinical data suggest that YL217 could be further developed in the treatment of CDH17-positive cancer patients." Preclinical • Oncology ...

8.

medilinkthera.com

medilinkthera.com/search

Medilink Therapeutics

MediLink Therapeutics Announces First Patient Dosed in Phase I Clinical Trial of YL217. July 2, 2025 – MediLink Therapeutics, a clinical-stage biotechnology ...