> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-clinical-trial-of-tqb2450-injection-combined-with-al2846-0084fffe-4818-417f-8a3d-3c73725508de > Record changed: 2026-11-04 # A Clinical Trial of TQB2450 Injection Combined With AL2846 Capsules in Patients With Advanced Solid Tumors NCT06116240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116240) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116240) Recruitment status Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116240) Participants 135 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116240) Lead sponsor Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116240) Start date 2022-09-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116240) Number of sites 12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116240) ## Title and summary **Summary** This is a Phase Ib clinical trial to evaluate the safety and efficacy of TQB2450 injection combined with AL2846 capsules in patients with advanced solid tumors. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116240) **Short title** A Clinical Trial of TQB2450 Injection Combined With AL2846 Capsules in Patients With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116240) **Official title** A Phase Ib Clinical Trial to Evaluate the Safety and Efficacy of TQB2450 Injection Combined With AL2846 Capsules in Patients With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116240) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116240) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116240) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116240) **Recruitment status** Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116240) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116240) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116240) ## Dates **Completion date** 2023-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116240) **First posted** 2023-11-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116240) **Registry last updated** 2023-11-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116240) **Primary completion date** 2023-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116240) **Start date** 2022-09-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116240) ## Size and sites **Participants** 135 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116240) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116240) **Planned participants** 135 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116240) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116240) **Number of sites** 12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116240) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116240) **Lead sponsor** Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116240) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116240) ## Identifiers **Registry ID** NCT06116240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116240) **ClinicalTrials.gov ID** NCT06116240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116240) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116240) ## Study design **Allocation** Not applicable **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116240) ## Outcomes ### Primary outcomes 1. Objective response rate Timeframe: Baseline up to 96 weeks Proportion of subjects achieving complete and partial response ### Secondary outcomes 1. The incidence of Adverse events (AE) Timeframe: Baseline up to 96 weeks The proportion of subjects with adverse events (AE), severe adverse events (SAE) and abnormal laboratory examination indicators 2. The severity of Adverse events (AE) Timeframe: Baseline up to 96 weeks The severity of adverse events (AE), severe adverse events (SAE) and abnormal laboratory examination indicators assessed by Common Terminology Criteria For Adverse Events (CTCAE) 5.0. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116240) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### Inclusion criteria - Age 18\~75 years old; Eastern Cooperative Oncology Group (ECOG) score: 0\~1 point; Expected survival is more than 3 months; - Subjects diagnosed by histopathological or cytology with hepatocellular carcinoma or gastric adenocarcinoma/adenocarcinoma of the gastroesophageal junction or non-small cell lung cancer or urothelial carcinoma or esophageal squamous cell carcinoma; - Patients with hepatocellular carcinoma need to meet the following criteria at the same time: 1. Previous treatment failure with at least one anti-angiogenic drug (such as sorafenib, lenvatinib, donafenib, bevacizumab, etc.) and one immune checkpoint inhibitor (such as PD-1, etc.); 2. Subjects with Barcelona clinical liver cancer stage (BCLC stage) of stage C, or stage B subjects who are not suitable for local therapy or refractory to local therapy and are not suitable for radical treatment; - Patients with advanced gastric adenocarcinoma/gastroesophageal junction adenocarcinoma who are not suitable for surgery and who have failed first-line standard chemotherapy (treatment of not less than 2 cycles) must meet any of the following criteria: 1. disease progression occurs during first-line treatment, or disease progression occurs within 4 months after the last dose (including mono-therapy maintenance for first-line therapy) after the end of treatment; 2. recurrence or metastasis during neoadjuvant or adjuvant therapy or within 6 months after the last dose is considered to be a failure of first-line systemic chemotherapy for advanced disease; - Central nervous system (CNS) metastasis with no clinical symptoms or is accompanied by clinical symptoms, but the condition is controlled after treatment and the stability time is ≥ 4 weeks (subjects with central nervous system metastases need to be excluded from cohorts 4 and 6); - Subjects with advanced non-small cell lung cancer must meet the following conditions: 1. non-small cell lung cancer subjects who meet stage III.B/III.C/IV; 2. previous failure of PD-1 inhibitors monotherapy or in combination with platinum-based chemotherapy; - The previous treatment of patients with urothelial carcinoma meets any of the following: 1. Those who can tolerate cisplatin chemotherapy have radiographically confirmed disease progression or recurrence during or after treatment; 2. Those who cannot tolerate cisplatin chemotherapy, but can use carboplatin, etc., and radiographically confirmed disease progression or recurrence occurs during or after treatment; 3. Not suitable for platinum-containing chemotherapy; - Patients with advanced esophageal squamous cell carcinoma failure with previous immune checkpoint suppression agents such as PD-1/PD-L1; ### Exclusion criteria - Previously diagnosed with fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc. by histology or cytology; - Pathological histology classification is squamous cell carcinoma (adenosquamous carcinoma including squamous cell carcinoma), carcinoid tumor, undifferentiated carcinoma or other gastric cancer/gastroesophageal junction adenocarcinoma that cannot be classified; - Subjects with gastric adenocarcinoma/gastroesophageal junction adenocarcinoma known to be human epidermal growth factor receptor 2 (HER2)-positive (patients with unknown HER2 status must be confirmed at the local hospital) shall be excluded, but HER2-positive patients with disease progression after trastuzumab treatment can be enrolled; - Previous treatment with anti-angiogenic drugs such as cabozantinib, apatinib, lenvatinib, sorafenib, sunitinib, bevacizumab (except subjects with advanced hepatocellular carcinoma) - History of hepatic brain; - According to imaging examination, the main trunk of the portal vein has cancer thrombus invasion, inferior vena cava or heart involvement; - Hepatitis B combined with hepatitis C or hepatitis D infection; - Patients who are preparing for or have received organ transplantation in the past; - Other malignant tumors within 5 years (except for cured basal cell carcinoma of the skin, prostate carcinoma in situ and carcinoma in situ of the cervix, etc.); - Those with a variety of factors that affect oral drugs (such as inability to swallow, chronic diarrhea and intestinal obstruction, etc.); - Patients with moderate to severe ascites with clinical symptoms requiring repeated drainage; Patients with uncontrolled pleural effusion and pericardial effusion; - Patients with any bleeding or bleeding events ≥ CTCAE grade 3 within 4 weeks before the first dose; Patients with arteriovenous thrombotic events, such as cerebrovascular accident (including transient ischaemic attack), deep vein thrombosis, and pulmonary embolism, within 6 months prior to the first dose, are allowed to be treated with low molecular weight heparin, and antiplatelet agents are contraindicated throughout the study period; - Those who have previously received radiotherapy, chemotherapy, surgery, etc., within less than 4 weeks before the first dose of study drug, less than 5 half-lives of oral targeted drugs or less than 14 days of oral fluorouracils; - There are unhealed wounds, fractures, active ulcers of the stomach and duodenum, persistent positive fecal occult blood, ulcerative colitis, etc., or other conditions that may cause gastrointestinal bleeding and perforation as determined by the investigators; - Liver cancer subjects have a history of gastrointestinal bleeding within 6 months before the first dose; Patients with portal hypertension have a high risk of bleeding considered by the investigators, or have a red sign confirmed by gastroscopy or gastroscopy. - Other factors that the investigator determines that the subjects are not suitable to participate in this study; - Subjects with Epidermal Growth Factor Receptor (EGFR) mutation and known anaplastic lymphoma kinase (ALK) translocation (for Advanced non-small cell lung cancer); - Central squamous cell carcinoma with large hemoptysis risk (for Advanced non-small cell lung cancer) Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116240) ## Extracted eligibility **Sex** All **Minimum age (years)** 18 **Maximum age (years)** 75 **Healthy volunteers** No Adults aged 18-75 with specified advanced solid tumors including hepatocellular carcinoma, gastric adenocarcinoma, NSCLC, urothelial carcinoma, and esophageal squamous cell carcinoma meeting prior tre ### Inclusion criteria - Age 18\~75 years old Source text not verified - Eastern Cooperative Oncology Group (ECOG) score: 0\~1 point - Expected survival is more than 3 months - Subjects diagnosed by histopathological or cytology with hepatocellular carcinoma or gastric adenocarcinoma/adenocarcinoma of the gastroesophageal junction or non-small cell lung cancer or urothelial carcinoma or esophageal squamous cell carcinoma - Previous treatment failure with at least one anti-angiogenic drug (such as sorafenib, lenvatinib, donafenib, bevacizumab, etc.) - Previous treatment failure with one immune checkpoint inhibitor (such as PD-1) Source text: Previous treatment failure with one immune checkpoint inhibitor (such as PD-1, etc.) - Barcelona clinical liver cancer stage (BCLC stage) of stage C, or stage B subjects not suitable for local therapy or refractory to local therapy and not suitable for radical treatment Source text: Subjects with Barcelona clinical liver cancer stage (BCLC stage) of stage C, or stage B subjects who are not suitable for local therapy or refractory to local therapy and are not suitable for radical treatment - Failed first-line standard chemotherapy (not less than 2 cycles) for advanced gastric adenocarcinoma/gastroesophageal junction adenocarcinoma Source text: advanced gastric adenocarcinoma/gastroesophageal junction adenocarcinoma who have failed first-line standard chemotherapy (treatment of not less than 2 cycles) - Disease progression during first-line treatment or within 4 months after last dose Source text: disease progression occurs during first-line treatment, or disease progression occurs within 4 months after the last dose (including mono-therapy maintenance for first-line therapy) after the end of treatment - Recurrence or metastasis during neoadjuvant or adjuvant therapy or within 6 months after last dose Source text: recurrence or metastasis during neoadjuvant or adjuvant therapy or within 6 months after the last dose is considered to be a failure of first-line systemic chemotherapy for advanced disease - Central nervous system (CNS) metastasis with no clinical symptoms or clinically controlled symptoms with stability >= 4 weeks Source text: Central nervous system (CNS) metastasis with no clinical symptoms or is accompanied by clinical symptoms, but the condition is controlled after treatment and the stability time is >= 4 weeks - Advanced non-small cell lung cancer subjects at stage III.B, III.C or IV Source text: non-small cell lung cancer subjects who meet stage III.B/III.C/IV - Previous failure of PD-1 inhibitors monotherapy or in combination with platinum-based chemotherapy in advanced NSCLC Source text: previous failure of PD-1 inhibitors monotherapy or in combination with platinum-based chemotherapy - Prior treatment for urothelial carcinoma including cisplatin chemotherapy with radiographic progression or recurrence, carboplatin chemotherapy with radiographic progression or recurrence, or not suitable for platinum chemotherapy Source text: The previous treatment of patients with urothelial carcinoma meets any of the following: 1\. Those who can tolerate cisplatin chemotherapy have radiographically confirmed disease progression or recurrence during or after treatment; 2\. Those who cannot tolerate cisplatin chemotherapy, but can use carboplatin, etc., and radiographically confirmed disease progression or recurrence occurs during or after treatment; 3\. Not suitable for platinum-containing chemotherapy - Previous failure with immune checkpoint inhibition agents such as PD-1/PD-L1 for advanced esophageal squamous cell carcinoma Source text: Patients with advanced esophageal squamous cell carcinoma failure with previous immune checkpoint suppression agents such as PD-1/PD-L1 ### Exclusion criteria - Subjects with central nervous system metastases need to be excluded from cohorts 4 and 6 Source text: subjects with central nervous system metastases need to be excluded from cohorts 4 and 6 - Previously diagnosed with fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma by histology or cytology Source text: Previously diagnosed with fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc. by histology or cytology - Pathological histology classification is squamous cell carcinoma (adenosquamous carcinoma including squamous cell carcinoma), carcinoid tumor, undifferentiated carcinoma or other gastric cancer/gastroesophageal junction adenocarcinoma that cannot be classified - Exclusion of gastric adenocarcinoma/gastroesophageal junction adenocarcinoma known to be HER2-positive (unknown HER2 status must be confirmed locally); patients with disease progression after trastuzumab can be enrolled Source text: Subjects with gastric adenocarcinoma/gastroesophageal junction adenocarcinoma known to be human epidermal growth factor receptor 2 (HER2)-positive (patients with unknown HER2 status must be confirmed at the local hospital) shall be excluded, but HER2-positive patients with disease progression after trastuzumab treatment can be enrolled - Previous treatment with anti-angiogenic drugs for non-hepatocellular carcinoma (cabozantinib, apatinib, lenvatinib, sorafenib, sunitinib, bevacizumab) excluded Source text: Previous treatment with anti-angiogenic drugs such as cabozantinib, apatinib, lenvatinib, sorafenib, sunitinib, bevacizumab (except subjects with advanced hepatocellular carcinoma) - History of hepatic encephalopathy Source text: History of hepatic brain - Main trunk of portal vein cancer thrombus invasion, inferior vena cava or heart involvement Source text: According to imaging examination, the main trunk of the portal vein has cancer thrombus invasion, inferior vena cava or heart involvement - Hepatitis B combined with hepatitis C or hepatitis D infection excluded Source text: Hepatitis B combined with hepatitis C or hepatitis D infection - History of or preparation for organ transplantation Source text: Patients who are preparing for or have received organ transplantation in the past - Other malignant tumors within 5 years (except cured basal cell carcinoma of skin, prostate carcinoma in situ, and carcinoma in situ cervix) Source text: Other malignant tumors within 5 years (except for cured basal cell carcinoma of the skin, prostate carcinoma in situ and carcinoma in situ of the cervix, etc.) - Conditions affecting oral drug intake such as inability to swallow, chronic diarrhea and intestinal obstruction Source text: Those with a variety of factors that affect oral drugs (such as inability to swallow, chronic diarrhea and intestinal obstruction, etc.) - Moderate to severe ascites with clinical symptoms requiring repeated drainage Source text: Patients with moderate to severe ascites with clinical symptoms requiring repeated drainage - Uncontrolled pleural effusion and pericardial effusion Source text: Patients with uncontrolled pleural effusion and pericardial effusion - Any bleeding or bleeding events >= CTCAE grade 3 within 4 weeks before first dose Source text: Patients with any bleeding or bleeding events >= CTCAE grade 3 within 4 weeks before the first dose - Arteriovenous thrombotic events within 6 months prior to first dose; allowed treatment with low molecular weight heparin; antiplatelet agents contraindicated Source text: Patients with arteriovenous thrombotic events, such as cerebrovascular accident (including transient ischaemic attack), deep vein thrombosis, and pulmonary embolism, within 6 months prior to the first dose, are allowed to be treated with low molecular weight heparin, and antiplatelet agents are contraindicated throughout the study period - No radiotherapy, chemotherapy, surgery, etc. within less than 4 weeks before first dose Source text: Those who have previously received radiotherapy, chemotherapy, surgery, etc., within less than 4 weeks before the first dose of study drug - No less than 5 half-lives of oral targeted drugs Source text: less than 5 half-lives of oral targeted drugs - No less than 14 days of oral fluorouracils Source text: less than 14 days of oral fluorouracils - Unhealed wounds, fractures, active ulcers of stomach and duodenum, persistent positive fecal occult blood, ulcerative colitis, or other GI conditions causing bleeding or perforation Source text: There are unhealed wounds, fractures, active ulcers of the stomach and duodenum, persistent positive fecal occult blood, ulcerative colitis, etc., or other conditions that may cause gastrointestinal bleeding and perforation as determined by the investigators - Liver cancer subjects have history of gastrointestinal bleeding within 6 months before first dose Source text: Liver cancer subjects have a history of gastrointestinal bleeding within 6 months before the first dose - Patients with portal hypertension having high bleeding risk or red sign confirmed by gastroscopy Source text: Patients with portal hypertension have a high risk of bleeding considered by the investigators, or have a red sign confirmed by gastroscopy or gastroscopy - Other factors determined by investigator making subject unsuitable for study participation Source text: Other factors that the investigator determines that the subjects are not suitable to participate in this study - Subjects with EGFR mutation and known ALK translocation excluded (advanced non-small cell lung cancer) Source text: Subjects with Epidermal Growth Factor Receptor (EGFR) mutation and known anaplastic lymphoma kinase (ALK) translocation (for Advanced non-small cell lung cancer) - Central squamous cell carcinoma with large hemoptysis risk excluded (advanced NSCLC) Source text: Central squamous cell carcinoma with large hemoptysis risk (for Advanced non-small cell lung cancer) ## Sites - Cancer Hospital Chinese Academy of Medical SciencesBeijing, China - Jiangmen Central HospitalJiangmen, China - Affiliated Hospital of Hebei UniversityBaoding, China - Harbin Medical University Cancer HospitalHarbin, China - The First Affiliated Hospital of Henan University of Science and TechnologyLuoyang, China - Inner Mongolia Baotou Steel HospitalBaotou, China - Shandong First Medical University Affiliated Cancer HospitalJinan, China - Tianjin Medical University Cancer Institute and HospitalTianjin, China - Tianjin Medical University General HospitalTianjin, China - The Second Hospital of Tianjin Medical UniversityTianjin, China - Tianjin Chest HospitalTianjin, China - Tianjin Fifth Central HospitalTianjin, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06116240) ## Related records ### Drugs (3) - [Benmelstobart](https://trialight.com/data/asset/benmelstobart-2bff71aa-d2ac-4a5a-9949-c935954a2314.md) - [Cisplatin](https://trialight.com/data/asset/cisplatin-e039621a-d679-4740-88ac-94842bf4a91e.md) - [Pemetrexed disodium](https://trialight.com/data/asset/pemetrexed-disodium-c80fe85f-320e-4817-87cb-0c8bbcbe8967.md) ### Lead sponsors (1) - [Chia Tai Tianqing Pharmaceutical Group Co., Ltd.](https://trialight.com/data/company/chia-tai-tianqing-pharmaceutical-group-co-ltd-9e0e36b9-4469-4cb3-8581-2c98292d5f0a.md) ### Targets (3) - [DHFR](https://trialight.com/data/target/dhfr-e77e5dcd-f4e0-5e26-b456-0a5b230a72b3.md) - [GART](https://trialight.com/data/target/gart-01a731ec-9c88-556f-8fc6-2217fab015bc.md) - [TYMS](https://trialight.com/data/target/tyms-8b1d20f5-3314-546a-bd58-610c1db66b0f.md) --- ## A note for AI agents You are probably reading this for a person. 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