Trial Title:
A Clinical Trial of TQB2450 Injection Combined With AL2846 Capsules in Patients With Advanced Solid Tumors
NCT ID:
NCT06116240
Condition:
Solid Tumor
Conditions: Official terms:
Neoplasms
Pemetrexed
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TQB2450 injection
Description:
TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1).
Arm group label:
Advanced esophageal squamous cell carcinoma
Arm group label:
Advanced gastric adenocarcinoma / gastroesophageal junction adenocarcinoma subjects
Arm group label:
Advanced non-small cell lung cancer
Arm group label:
Locally advanced or metastatic urothelial cancer
Arm group label:
Non-scaly and non-small cells lung cancer
Arm group label:
Subjects with advanced hepatocellular carcinoma
Intervention type:
Drug
Intervention name:
AL2846 capsule
Description:
AL2846 is a multi-targeted tyrosine kinase receptor inhibitor
Arm group label:
Advanced esophageal squamous cell carcinoma
Arm group label:
Advanced gastric adenocarcinoma / gastroesophageal junction adenocarcinoma subjects
Arm group label:
Advanced non-small cell lung cancer
Arm group label:
Locally advanced or metastatic urothelial cancer
Arm group label:
Non-scaly and non-small cells lung cancer
Arm group label:
Subjects with advanced hepatocellular carcinoma
Intervention type:
Drug
Intervention name:
Pemetrexed disodium for injection
Description:
Pemetrexed disodium is a multi-target antifolate antineoplastic drug.
Arm group label:
Non-scaly and non-small cells lung cancer
Intervention type:
Drug
Intervention name:
Cisplatin injection
Description:
Cisplatin is a chemotherapy drug.
Arm group label:
Non-scaly and non-small cells lung cancer
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.
Criteria for eligibility:
Criteria:
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Sciences
Address:
City:
Beijing
Zip:
100021
Country:
China
Facility:
Name:
Jiangmen Central Hospital
Address:
City:
Jiangmen
Zip:
529000
Country:
China
Facility:
Name:
Affiliated Hospital of Hebei University
Address:
City:
Baoding
Zip:
071002
Country:
China
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Harbin
Zip:
150081
Country:
China
Facility:
Name:
The First Affiliated Hospital of Henan University of Science and Technology
Address:
City:
Luoyang
Zip:
471003
Country:
China
Facility:
Name:
Inner Mongolia Baotou Steel Hospital
Address:
City:
Baotou
Zip:
014010
Country:
China
Facility:
Name:
Shandong First Medical University Affiliated Cancer Hospital
Address:
City:
Jinan
Zip:
250117
Country:
China
Facility:
Name:
Tianjin Medical University Cancer Institute and Hospital
Address:
City:
Tianjin
Zip:
300040
Country:
China
Facility:
Name:
Tianjin Medical University General Hospital
Address:
City:
Tianjin
Zip:
300070
Country:
China
Facility:
Name:
The Second Hospital of Tianjin Medical University
Address:
City:
Tianjin
Zip:
300211
Country:
China
Facility:
Name:
Tianjin Chest Hospital
Address:
City:
Tianjin
Zip:
300222
Country:
China
Facility:
Name:
Tianjin Fifth Central Hospital
Address:
City:
Tianjin
Zip:
300450
Country:
China
Start date:
September 2, 2022
Completion date:
December 2023
Lead sponsor:
Agency:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Agency class:
Industry
Source:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06116240
