What side effects are associated with this type of intervention?

Common treatments for solid tumors, such as chemotherapy, immunotherapy, and targeted therapies, often come with a range of side effects. Chemotherapy can cause nausea, vomiting, hair loss, fatigue, and increased risk of infections due to bone marrow suppression. Immunotherapy, including agents like anti-PD-1 and anti-CTLA-4, may lead to immune-related adverse events such as rash, diarrhea, pneumonitis, and endocrinopathies. Targeted therapies can result in side effects like hypertension, hand-foot syndrome, and liver toxicity. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of advanced solid tumors, particularly those that target immune checkpoints and specific genetic mutations. Notable approvals include pembrolizumab (Keytruda) and nivolumab (Opdivo), both of which are PD-1 inhibitors used in various solid tumors like melanoma, non-small cell lung cancer, and head and neck cancer. Additionally, targeted therapies such as erlotinib (Tarceva) for EGFR-mutated non-small cell lung cancer and vemurafenib (Zelboraf) for BRAF-mutated melanoma have been approved. These treatments share similarities with investigational agents like YL201, which aim to provide new therapeutic options for patients with advanced solid tumors.

What other types of research exist?

Promising novel alternatives to YL201 for solid tumor patients include: 1) Nivolumab, an immune checkpoint inhibitor, which has shown efficacy in various solid tumors including non-small cell lung cancer (NSCLC) and malignant pleural mesothelioma. 2) Pembrolizumab, another immune checkpoint inhibitor, effective in NSCLC and Merkel cell carcinoma. 3) Atezolizumab, an anti-PD-L1 antibody, used in NSCLC and other solid tumors. 4) Cabozantinib, a tyrosine kinase inhibitor, showing promise in renal cell carcinoma and other solid tumors. 5) Avelumab, a PD-L1 inhibitor, effective in Merkel cell carcinoma and other cancers.

← Back to Search

Other

YL201 for Solid Tumors

Phase 1

Recruiting

Research Sponsored by MediLink Therapeutics (Suzhou) Co., Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1

Pathologically confirmed diagnosis of an advanced solid tumor for which prior standard treatment had proven to be ineffective or intolerable, or no standard treatment is available

Must not have

Uncontrolled third-space fluid that requires repeated drainage

Have a diagnosis of Gilbert's syndrome

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately within 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called YL201 in patients with advanced solid tumors that don't respond to current treatments. The study will determine the safest dose and see how effective the drug is in treating these tumors.

Who is the study for?

This trial is for adults with advanced solid tumors that haven't responded to existing treatments or have no standard treatment options. Participants must be over 18, able to follow the study plan, and provide tumor tissue samples. They should not have active hepatitis B/C, unresolved toxicities from previous cancer therapies (except certain conditions), or any condition that could affect participation.

What is being tested?

YL201 is being tested in a phase 1 trial involving two parts: dose escalation to find the maximum tolerated dose/recommended dosing, and dose expansion at these doses in selected tumor types. The goal is to determine safety and effectiveness of YL201 for patients with advanced solid tumors.

What are the potential side effects?

As this is a first-in-human study for YL201, specific side effects are unknown but may include typical reactions seen with cancer drugs such as fatigue, nausea, inflammation-related symptoms, allergic reactions or blood count changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am fully active or can carry out light work.

Select...

My advanced cancer has not responded to standard treatments, or there are none available.

Select...

I agree to use effective birth control and not donate eggs or sperm during and 6 months after the study.

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I need frequent procedures to remove excess body fluid.

Select...

I have been diagnosed with Gilbert's syndrome.

Select...

I haven't had cancer treatments like chemotherapy or immunotherapy recently.

Select...

I have a serious lung condition besides my cancer.

Select...

I have not received a live vaccine recently and do not plan to during the study.

Select...

I had a bad reaction to a specific cancer treatment (like topotecan).

Select...

I have an active hepatitis B or C infection.

Select...

I have or might have lung inflammation not caused by an infection.

Select...

I have a history of cancer spreading to the lining of my brain and spinal cord.

Select...

I have not had major surgery recently and do not expect any during the study.

Select...

I have had a stem cell transplant before starting the study drug.

Select...

I have heart problems that are not well-managed.

Select...

I am HIV positive.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately within 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately within 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately within 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Evaluate the objective response rate (ORR) for patients with solid tumors other than prostate cancer in Part 2, assessed using RECIST version 1.1

Evaluate the prostate-specific antigen (PSA) response rate for patients with prostate cancer in Part 2

Secondary study objectives

Evaluate the PSA progression-free survival (PSA-PFS) for patients with prostate cancer

Evaluate the disease control rate (DCR) for patients with solid tumors other than prostate cancer, assessed using RECIST version 1.1

Evaluate the duration of response (DoR) for patients with solid tumors other than prostate cancer, assessed using RECIST version 1.1

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose expansionExperimental Treatment1 Intervention

All participants enrolled in the dose expansion part

Group II: Dose escalationExperimental Treatment1 Intervention

All participants enrolled in the dose escalation part

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but also affects normal cells, leading to side effects. Targeted therapies, such as tyrosine kinase inhibitors, specifically target molecular pathways crucial for tumor growth and survival, thereby minimizing damage to normal cells. Immunotherapy, including checkpoint inhibitors, enhances the body's immune response against cancer cells. The investigational agent YL201, being studied for advanced solid tumors, likely falls into one of these categories, aiming to improve efficacy and reduce side effects. Understanding these mechanisms helps patients and doctors choose the most appropriate treatment based on the tumor's characteristics and the patient's overall health.

Promising novel therapies for the treatment of endometrial cancer.