Clinical Trials List
Protocol NumberYL211-INT-101-01/XO45990
NCT Number(ClinicalTrials.gov Identfier)NCT06384352
Not yet recruiting
2026-07-15 - 2031-08-31
Phase I
Not yet recruiting3
A Phase 1, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors
-
Sponsor
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/08/25
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Advanced Solid Tumors
Objectives
本試驗的目的是找出名為 YL211 的試驗性藥品（也稱為「試驗治療」）是否對具有稱為 cMET 的特定標記物的實體瘤有任何影響（好或壞）。
Test Drug
注射用凍晶粉末
輸注液
輸注液
Active Ingredient
YL211/RO7806767
Pembrolizumab
Pembrolizumab
Dosage Form
248
27C
27C
Dosage
200 mg
100mg/4ml
100mg/4ml
Endpoints
1.1.1.4 劑量遞增部分（第 1 部分和第 4 部分）的指標
主要指標：
• 不良事件 (AE) 的性質和頻率，以及根據美國國家癌症研究所 (NCI) 常見不良事
件評價標準 (CTCAE) v5.0 判定的嚴重程度
• 劑量限制毒性 (DLT) 的性質和頻率
1.1.1.5 回填納入部分（第 2 部分和第 5 部分）的指標
主要指標：
安全性指標：
• AE 的性質和頻率及嚴重程度、身體檢查結果（包括 ECOG PS）、生命徵象測量
值、標準臨床實驗室參數、SpO2 測量值、ECG 參數和 ECHO 結果
療效指標：
• 使用 RECIST 版本評估的 ORR
1.1.1.6 劑量擴展部分（第 3 部分和第 6 部分）的指標
主要指標：
療效指標：
• 使用 RECIST 第 1.1 版評估的 PFS，定義為從隨機分配至首次記錄疾病惡化 (PD)
或因任何原因死亡之日期的時間間隔，以先發生者為準
安全性指標：
• AE 的性質和頻率及嚴重程度、身體檢查結果（包括 ECOG PS）、生命徵象測量
值、標準臨床實驗室參數、SpO2 測量值、ECG 參數和 ECHO 結果
主要指標：
• 不良事件 (AE) 的性質和頻率，以及根據美國國家癌症研究所 (NCI) 常見不良事
件評價標準 (CTCAE) v5.0 判定的嚴重程度
• 劑量限制毒性 (DLT) 的性質和頻率
1.1.1.5 回填納入部分（第 2 部分和第 5 部分）的指標
主要指標：
安全性指標：
• AE 的性質和頻率及嚴重程度、身體檢查結果（包括 ECOG PS）、生命徵象測量
值、標準臨床實驗室參數、SpO2 測量值、ECG 參數和 ECHO 結果
療效指標：
• 使用 RECIST 版本評估的 ORR
1.1.1.6 劑量擴展部分（第 3 部分和第 6 部分）的指標
主要指標：
療效指標：
• 使用 RECIST 第 1.1 版評估的 PFS，定義為從隨機分配至首次記錄疾病惡化 (PD)
或因任何原因死亡之日期的時間間隔，以先發生者為準
安全性指標：
• AE 的性質和頻率及嚴重程度、身體檢查結果（包括 ECOG PS）、生命徵象測量
值、標準臨床實驗室參數、SpO2 測量值、ECG 參數和 ECHO 結果
Inclution Criteria
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.
For Part 1: History of an advanced solid tumors (including locally advanced unresectable or metastatic NSCLC, metastatic colorectal carcinoma (mCRC), advanced gastric adenocarcinoma (GAC)/ gastroesophageal junction adenocarcinoma (GEJA), pancreatic ductal adenocarcinoma (PDAC), hepatocellular carcinoma (HCC), intrahepatic biliary tract cancer (ih-BTC), and head and neck squamous cell carcinoma (HNSCC) who failed currently available standard therapies and are not amenable to surgical resection, or for whom no available standard therapy or no other approved therapeutic options that have demonstrated clinical benefit.
For Part 2: For patients with CRC: History of histologically or cytologically confirmed diagnosis of metastatic CRC and at least 2 prior regimens of standard treatment For patients with NSCLC: History of histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic NSCLC and no more than 2 lines of prior cytotoxic systemic therapy in the locally advanced or metastatic setting.
For Part 3: History of histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic non-squamous (Part 3A) or squamous (Part 3B) NSCLC and no more than 2 lines of prior systemic therapy
For Part 4: History of histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic non-squamous NSCLC who have progressed on or after 1 or 2 prior lines of systemic therapy
For Part 5 and Part 6 Histologically or cytologically documented locally advanced unresectable or metastatic non-squamous NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy and no prior systemic treatment for advanced unresectable or metastatic NSCLC
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.
For Part 1: History of an advanced solid tumors (including locally advanced unresectable or metastatic NSCLC, metastatic colorectal carcinoma (mCRC), advanced gastric adenocarcinoma (GAC)/ gastroesophageal junction adenocarcinoma (GEJA), pancreatic ductal adenocarcinoma (PDAC), hepatocellular carcinoma (HCC), intrahepatic biliary tract cancer (ih-BTC), and head and neck squamous cell carcinoma (HNSCC) who failed currently available standard therapies and are not amenable to surgical resection, or for whom no available standard therapy or no other approved therapeutic options that have demonstrated clinical benefit.
For Part 2: For patients with CRC: History of histologically or cytologically confirmed diagnosis of metastatic CRC and at least 2 prior regimens of standard treatment For patients with NSCLC: History of histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic NSCLC and no more than 2 lines of prior cytotoxic systemic therapy in the locally advanced or metastatic setting.
For Part 3: History of histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic non-squamous (Part 3A) or squamous (Part 3B) NSCLC and no more than 2 lines of prior systemic therapy
For Part 4: History of histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic non-squamous NSCLC who have progressed on or after 1 or 2 prior lines of systemic therapy
For Part 5 and Part 6 Histologically or cytologically documented locally advanced unresectable or metastatic non-squamous NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy and no prior systemic treatment for advanced unresectable or metastatic NSCLC
Exclusion Criteria
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.
Previously received an ADC consisting of a TopoI
Received continuous systemic steroids therapy for more than 28 days or require long-term (≥ 28 days) use of systemic steroids therapy within 28 days before the first administration, or have other acquired or congenital immune deficiency diseases. (Note: The protocol lists specific situational exceptions immediately following this clause).
A history of leptomeningeal carcinomatosis or carcinomatous meningitis
Brain metastasis, except for the following situations:
Participants with asymptomatic brain metastasis who do not require immediate local or systemic treatment (such as mannitol or steroids, surgery, or radiotherapy) are allowed to be enrolled If the participant's brain metastasis is treated and the condition of the metastasis is stable (brain imaging examination at least 2 weeks before the first administration shows that the lesion is stable, there is no evidence of new or original brain metastasis enlargement, there are no new neurological symptoms, and immediate local or systemic treatment is not required), admission is allowed
Clinically significant concomitant pulmonary disease, including but not limited to:
A history of drug-induced pneumonitis A history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that requires steroids, current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
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.
Previously received an ADC consisting of a TopoI
Received continuous systemic steroids therapy for more than 28 days or require long-term (≥ 28 days) use of systemic steroids therapy within 28 days before the first administration, or have other acquired or congenital immune deficiency diseases. (Note: The protocol lists specific situational exceptions immediately following this clause).
A history of leptomeningeal carcinomatosis or carcinomatous meningitis
Brain metastasis, except for the following situations:
Participants with asymptomatic brain metastasis who do not require immediate local or systemic treatment (such as mannitol or steroids, surgery, or radiotherapy) are allowed to be enrolled If the participant's brain metastasis is treated and the condition of the metastasis is stable (brain imaging examination at least 2 weeks before the first administration shows that the lesion is stable, there is no evidence of new or original brain metastasis enlargement, there are no new neurological symptoms, and immediate local or systemic treatment is not required), admission is allowed
Clinically significant concomitant pulmonary disease, including but not limited to:
A history of drug-induced pneumonitis A history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that requires steroids, current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
The Estimated Number of Participants
-
Taiwan
32 participants
-
Global
430 participants
