YL242 for Cancer

Recruiting at 14 trial locations

Overseen By Medilink Study Team

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

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

Must not be taking: Topoisomerase inhibitors

Disqualifiers: Cardiovascular, Pulmonary, Leptomeningeal, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately 36 months

424 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called YL242 for individuals with advanced solid tumors, which are cancers that have either spread or cannot be surgically removed. The trial evaluates the safety and tolerability of YL242 when administered alone or in combination with other treatments, such as Pembrolizumab (an immune therapy) and chemotherapy drugs like 5-FU and LV. Individuals who have undergone at least one round of previous cancer treatment and have specific types of advanced cancer may qualify for this study. As a Phase 1 trial, the research focuses on understanding how YL242 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications for the YL242 cancer trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that YL242, a new cancer treatment, is being tested for safety both alone and with other drugs. Early results from past studies suggest that YL242 stops the growth of new blood vessels and releases agents that kill cancer cells. Although confirming its safety is premature, its presence in advanced trials indicates some safety in earlier tests.

The safety of YL242 combined with pembrolizumab is still under study. Other studies have shown pembrolizumab to be safe, and many patients tolerate it well. Common side effects include tiredness and skin reactions, but most are manageable.

For the combination of YL242 with 5-FU and LV, research indicates that 5-FU and LV are generally well-tolerated, though they can cause side effects like nausea and mouth sores.

Overall, while YL242 shows promise, it is still under testing to ensure safety for people. Those considering joining the trial should discuss the possible risks and benefits with their doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard cancer treatments that typically focus on surgery, chemotherapy, or radiation, YL242 offers a novel approach by being part of a unique combination therapy. Researchers are particularly excited about YL242 because it works alongside pembrolizumab, an immunotherapy drug, to potentially enhance the body's immune response against cancer cells. Additionally, YL242 is administered intravenously, allowing for precise control over dosage and timing, which may improve its effectiveness and reduce side effects compared to oral medications. This innovative combination and delivery method aim to offer a more targeted and potentially more effective treatment option for cancer patients.

What evidence suggests that this trial's treatments could be effective for cancer?

Research has shown that YL242 could be a promising treatment for advanced solid tumors. YL242 stops the growth of new blood vessels that tumors need to grow. Earlier studies found that this method helped patients live longer and prevented disease progression. In this trial, participants will receive YL242 in different combinations. Some will receive YL242 with pembrolizumab, an immunotherapy drug that boosts the immune system's ability to fight cancer. Others will receive YL242 with 5-FU and LV, chemotherapy drugs effective in treating certain cancers. The combination of YL242 with these drugs is being studied to determine if it can lead to even better results for patients with advanced cancer. ^{4 5 6 7 8}

Are You a Good Fit for This Trial?

Adults (≥18 years) with advanced solid tumors who have had at least one prior systemic anti-tumor therapy can join this trial. Specific groups include those with non-squamous NSCLC, mCRC, or HER2-negative G/GEJ cancer without previous systemic treatment. Participants must be in good physical condition and not have significant heart, lung diseases, or mental health issues that could affect participation.

Inclusion Criteria

I am fully active or have some restrictions but can still do light work.

My organs and bone marrow are working well.

Tumor type: Part 1-3 - Advanced/unresectable or metastatic solid malignant tumor; Have received at least one prior line of systemic anti-tumor therapy. Part 4 - Locally advanced or metastatic non-squamous NSCLC without AGA and HCC; Have not received any systemic anti-tumor therapy. Part 5 - mCRC, have received at least one prior line of systemic anti-tumor therapy. Part 6 - Advanced or metastatic HER2-negative G/GEJ; have received at least one prior line of systemic anti-tumor therapy

Exclusion Criteria

I had a bad reaction to a specific cancer treatment.

I do not have any major heart or brain blood vessel problems.

I have a serious lung condition besides cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive YL242 monotherapy and combination therapy with Pembrolizumab, 5-FU, and LV as per protocol defined dose level and frequency

Approximately 36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including collection of treatment-emergent adverse events (TEAEs)

42 days post last dose

What Are the Treatments Tested in This Trial?

Interventions

• 5-FU
• LV
• Pembrolizumab
• YL242

Trial Overview The study is testing YL242 alone and in combination with Pembrolizumab and/or chemotherapy agents like 5-FU and LV on patients with various advanced cancers. It's an open-label trial where everyone knows what treatments are given to evaluate safety and effectiveness of these combinations.

How Is the Trial Designed?

Group I: Part 6: Combination Dose Optimization and Expansion Experimental Treatment 1 Intervention

Participants receive YL242, pembrolizumab and 5-FU, administered via intravenous (IV) solution at protocol defined frequency.

Group II: Part 5: Combination Dose Optimization and Expansion Experimental Treatment 1 Intervention

Participants receive YL242, 5-FU and LV, administered via intravenous (IV) solution.

Group III: Part 3 and 4: Combination Dose Escalation & Expansion Experimental Treatment 1 Intervention

Participants receive YL242 at protocol defined dose level, in combination with Pembrolizumab (200 mg), administered via intravenous (IV) solution at protocol defined dose level and frequency.

Group IV: Part 1 and Part 2: Mono Dose Escalation & Expansion Experimental Treatment 1 Intervention

Participants receive YL242 administered via intravenous (IV) solution per protocol defined dose level and frequency.

Who Is Running the Clinical Trial?

MediLink Therapeutics (Suzhou) Co., Ltd.

Lead Sponsor

Trials

12

Recruited

3,400+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07197827

A Study of YL242 in Subjects With Advanced Solid Tumors A Phase 1/2, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL242 ...

2. patlynk.com patlynk.com/trial/NCT07197827

YL242 Monotherapy and Combinations for Advanced Solid ... Through regular health assessments, the study aims to gather comprehensive information on the potential benefits and any possible side effects of YL242, ...

3. researchgate.net researchgate.net/publication/390988075_Abstract_3140_Preclinical_development_of_YL242_a_non-internalized_antibody-drug_conjugate_ADC_targeting_soluble_VEGF_for_treatment_of_solid_tumors

Abstract 3140: Preclinical development of YL242, a non- ... Angiogenesis inhibitors significantly improved OS (HR = 0.70, 95% CI [0.58, 0.84]) and PFS (HR = 0.50, 95% CI [0.43, 0.57]). ... Conclusions.

4. withpower.com withpower.com/trial/phase-2-solid-tumors-advanced-solid-tumors-8-2025-c2ec6

YL242 for Cancer · Recruiting Participants for Phase ... This is a multicenter, open-label study to evaluate the safety and tolerability of YL242 monotherapy and combination in participants with advanced solid ...

5. adcreview.com adcreview.com/clinical-trials-update/aacr-2025-china-is-leading-the-way-in-adc-development/

AACR 2025: China is Leading the Way in ADC Development MediLink Therapeutics presents updated data from YL242 (see ADC Drugmap), a novel, non-internalizing, ADC designed to targets free (soluble) ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07197827

A Study of YL242 in Subjects With Advanced Solid Tumors This is a multicenter, open-label study to evaluate the safety and tolerability of YL242 monotherapy and combination in participants with ...

7. aacrjournals.org aacrjournals.org/cancerres/article/85/8_Supplement_1/3140/758853/Abstract-3140-Preclinical-development-of-YL242-a

Preclinical development of YL242, a non-internalized antibody ... YL242 is designed to leverage anticancer activity through both anti-angiogenesis by the VEGF antibody and the cytotoxicity of the extracellularly released ...

8. oncologypipeline.com oncologypipeline.com/apexonco/milestone-tmalin

A milestone for Tmalin | ApexOnco - Clinical Trials news ... Next up is YL242, which MediLink said cleared a US IND in May; the newly revealed solid tumour trial is to be carried out in the US as well as ...