RecruitingPhase 1

Safety,Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors

United States, Australia, Canada500 participantsStarted 2024-05-01

Plain-language summary

This is a multicenter, open-label, Phase 1 study. The study will enroll subjects with advanced solid tumors. It consists of six parts. Objectives for Dose-Escalation Parts (Part 1 and Part 4) To evaluate the safety and tolerability of YL211 as monotherapy in patients with selected advanced solid tumors (Part 1) and in combination with pembrolizumab in patients with second or third line locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) (Part 4) To determine the maximum tolerated dose (MTD) and select the recommended expansion dose(s) (RED(s)) of YL211 as monotherapy in patients with advanced solid tumors (Part 1) and in combination with pembrolizumab in patients with second line locally advanced unresectable or metastatic non-squamous NSCLC (Part 4) Objectives for Backfill Enrollment Parts (Part 2 and Part 5) To better estimate and characterize the safety and efficacy of YL211 as monotherapy in patients with metastatic colorectal cancer (mCRC) or locally advanced unresectable or metastatic NSCLC (Part 2) and in combination with pembrolizumab in patients with previously untreated locally advanced unresectable or metastatic non-squamous NSCLC (Part 5) To select the RED(s) of YL211 as monotherapy in patients with metastatic colorectal cancer (mCRC) or locally advanced unresectable or metastatic NSCLC (Part 2) and in combination with pembrolizumab in patients with previously untreated locally advanced unresectable or metastatic non-squamous NSCLC (Part 5) Objectives for the Dose-Expansion Parts (Part 3 and Part 6) To further characterize the safety and efficacy of YL211 as monotherapy (Part 3) in patients with locally advanced unresectable or metastatic non-squamous or squamous NSCLC and in combination with pembrolizumab in patients with previously untreated locally advanced unresectable or metastatic non- squamous NSCLC (Part 6) To compare the clinical activity of YL211 in combination with pembrolizumab against pembrolizumab, pemetrexed, and platinum-based chemotherapy (cisplatin or carboplatin) in participants with previously untreated advanced unresectable or metastatic non-squamous NSCLC (Part 6)

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Informed of the trial before the start of the trial and voluntarily sign their name and date on the ICF.
. Aged ≥18 years.
. Be able and willing to comply with protocol visits and procedures.
. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or
. Adequate organ and bone marrow function.

Exclusion criteria

. Prior treatment with an agent targeting c-MET (including antibody, ADC, chimeric antigen receptor T cell \[CAR-T\], and other drugs) with the exception of prior treatment with MET-targeted TKIs which are allowed.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Nature and frequency of adverse events (AEs) with severity determined according to NCI CTCAE v5.0 (Part 1 and Part 4)

Timeframe: Approximately within 36 months

Nature and frequency of dose-limiting toxicities (DLTs) (Part 1 and Part 4)

Timeframe: Approximately within 36 months

Nature and frequency of AEs with severity, physical examination findings (including ECOG PS), vital sign measurements, standard clinical laboratory parameters, SpO2 measurements, ECG parameters, and ECHO findings (Part 2 and Part 5)

Timeframe: Approximately within 36 months

ORR assessed using RECIST version 1.1 (Part 2 and Part 5)

Timeframe: Approximately within 36 months

PFS using RECIST version 1.1 defined as the time interval of randomization to the date of first documentation of PD or death due to any cause, whichever occurs first (Part 3 and Part 6)

Timeframe: approximately 36 months

Trial details

NCT IDNCT06384352

SponsorMediLink Therapeutics (Suzhou) Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2031-06-30

Contact for this trial

MediLink Study Team

+86 0512-62858368 clinicaltrials@medilinkthera.com

View on ClinicalTrials.gov More Advanced Solid Tumors trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Informed of the trial before the start of the trial and voluntarily sign their name and date on the ICF.
. Aged ≥18 years.
. Be able and willing to comply with protocol visits and procedures.
. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or
. Adequate organ and bone marrow function.

Exclusion criteria

. Prior treatment with an agent targeting c-MET (including antibody, ADC, chimeric antigen receptor T cell \[CAR-T\], and other drugs) with the exception of prior treatment with MET-targeted TKIs which are allowed.

What they're measuring

Nature and frequency of adverse events (AEs) with severity determined according to NCI CTCAE v5.0 (Part 1 and Part 4)

Timeframe: Approximately within 36 months

Nature and frequency of dose-limiting toxicities (DLTs) (Part 1 and Part 4)

Timeframe: Approximately within 36 months

ORR assessed using RECIST version 1.1 (Part 2 and Part 5)

Timeframe: Approximately within 36 months

PFS using RECIST version 1.1 defined as the time interval of randomization to the date of first documentation of PD or death due to any cause, whichever occurs first (Part 3 and Part 6)

Timeframe: approximately 36 months