Solid TumorPhase 1NCT06116240
A Clinical Trial of TQB2450 Injection Combined With AL2846 Capsules in Patients With Advanced Solid Tumors
A Phase 1 study testing TQB2450 injection, AL2846 capsule and Pemetrexed disodium for injection in people with Solid Tumor, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 12 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- TQB2450 injection, AL2846 capsule and Pemetrexed disodium for injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 12 sitesChina
- Study dates
- 2 Sep 2022to Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.);
- 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:
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- 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 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:
- 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;
- The previous treatment of patients with urothelial carcinoma meets any of the following:
- Those who can tolerate cisplatin chemotherapy have radiographically confirmed disease progression or recurrence during or after treatment;
- Those who cannot tolerate cisplatin chemotherapy, but can use carboplatin, etc., and radiographically confirmed disease progression or recurrence occurs during or after treatment;
- 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;
Who cannot join
- 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;
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- 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)
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
Affiliated Hospital of Hebei University
Baoding, Hebei, 071002
Inner Mongolia Baotou Steel Hospital
Baotou, Neimenggu, 014010
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Jiangmen Central Hospital
Jiangmen, Guangdong, 529000
Shandong First Medical University Affiliated Cancer Hospital
Jinan, Shandong, 250117
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471003
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300040
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300070
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 300211
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, 300222
Tianjin Fifth Central Hospital
Tianjin, Tianjin Municipality, 300450
About this study
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
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.
- Conditions
- Solid Tumor
- Being tested
- TQB2450 injection, AL2846 capsule, Pemetrexed disodium for injection, Cisplatin injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB2450 injectionDrug
TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1).
AL2846 capsuleDrug
AL2846 is a multi-targeted tyrosine kinase receptor inhibitor
Pemetrexed disodium for injectionDrug
Pemetrexed disodium is a multi-target antifolate antineoplastic drug.
Cisplatin injectionDrug
Cisplatin is a chemotherapy drug.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with advanced hepatocellular carcinoma | Experimental | TQB2450 injection, 21 days as a treatment cycle. AL2846 capsule, 21 days as a treatment cycle. Receives: Drug: TQB2450 injection; Drug: AL2846 capsule |
| Advanced gastric adenocarcinoma / gastroesophageal junction adenocarcinoma subjects | Experimental | TQB2450 injection, 21 days as a treatment cycle. AL2846 capsule, 21 days as a treatment cycle. Receives: Drug: TQB2450 injection; Drug: AL2846 capsule |
| Advanced non-small cell lung cancer | Experimental | TQB2450 injection, 21 days as a treatment cycle. AL2846 capsule, 21 days as a treatment cycle. Receives: Drug: TQB2450 injection; Drug: AL2846 capsule |
| Locally advanced or metastatic urothelial cancer | Experimental | TQB2450 injection, 21 days as a treatment cycle. AL2846 capsule, 21 days as a treatment cycle. Receives: Drug: TQB2450 injection; Drug: AL2846 capsule |
| Advanced esophageal squamous cell carcinoma | Experimental | TQB2450 injection, 21 days as a treatment cycle. AL2846 capsule, 21 days as a treatment cycle. Receives: Drug: TQB2450 injection; Drug: AL2846 capsule |
| Non-scaly and non-small cells lung cancer | Experimental | TQB2450 injection, 21 days as a treatment cycle. AL2846 capsule, 21 days as a treatment cycle. Pemetrexed disodium for injection, 21 days as a treatment cycle. Cisplatin injection, 21 days as a treatment cycle. Receives: Drug: TQB2450 injection; Drug: AL2846 capsule; Drug: Pemetrexed disodium for injection; Drug: Cisplatin injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Proportion of subjects achieving complete and partial response
Measured: Baseline up to 96 weeks
Secondary outcomes (2)
The incidence of Adverse events (AE)
The proportion of subjects with adverse events (AE), severe adverse events (SAE) and abnormal laboratory examination indicators
Measured: Baseline up to 96 weeks
The severity of Adverse events (AE)
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.
Measured: Baseline up to 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start2 Sep 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06116240
- Sponsor's protocol ID
- TQB2450-AL2846-I-01
- Status last verified
- Oct 2023
- First submitted
- 31 Oct 2023
- Last updated
- 3 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06116240
- Acronym / sponsor ID
- TQB2450-AL2846-I-01
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Sep 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Subjects with advanced hepatocellular carcinoma | Experimental | Drug: TQB2450 injection, Drug: AL2846 capsuleTQB2450 injection, 21 days as a treatment cycle. AL2846 capsule, 21 days as a treatment cycle. |
| Advanced gastric adenocarcinoma / gastroesophageal junction adenocarcinoma subjects | Experimental | Drug: TQB2450 injection, Drug: AL2846 capsuleTQB2450 injection, 21 days as a treatment cycle. AL2846 capsule, 21 days as a treatment cycle. |
| Advanced non-small cell lung cancer | Experimental | Drug: TQB2450 injection, Drug: AL2846 capsuleTQB2450 injection, 21 days as a treatment cycle. AL2846 capsule, 21 days as a treatment cycle. |
| Locally advanced or metastatic urothelial cancer | Experimental | Drug: TQB2450 injection, Drug: AL2846 capsuleTQB2450 injection, 21 days as a treatment cycle. AL2846 capsule, 21 days as a treatment cycle. |
| Advanced esophageal squamous cell carcinoma | Experimental | Drug: TQB2450 injection, Drug: AL2846 capsuleTQB2450 injection, 21 days as a treatment cycle. AL2846 capsule, 21 days as a treatment cycle. |
| Non-scaly and non-small cells lung cancer | Experimental | Drug: TQB2450 injection, Drug: AL2846 capsule, Drug: Pemetrexed disodium for injection, Drug: Cisplatin injectionTQB2450 injection, 21 days as a treatment cycle. AL2846 capsule, 21 days as a treatment cycle. Pemetrexed disodium for injection, 21 days as a treatment cycle. Cisplatin injection, 21 days as a treatment cycle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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:
- 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:
- 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);
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQB2450 injectionTQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1). | Drug | Advanced esophageal squamous cell carcinoma, Advanced gastric adenocarcinoma / gastroesophageal junction adenocarcinoma subjects, Advanced non-small cell lung cancer, Locally advanced or metastatic urothelial cancer, Non-scaly and non-small cells lung cancer, Subjects with advanced hepatocellular carcinoma |
| AL2846 capsuleAL2846 is a multi-targeted tyrosine kinase receptor inhibitor | Drug | Advanced esophageal squamous cell carcinoma, Advanced gastric adenocarcinoma / gastroesophageal junction adenocarcinoma subjects, Advanced non-small cell lung cancer, Locally advanced or metastatic urothelial cancer, Non-scaly and non-small cells lung cancer, Subjects with advanced hepatocellular carcinoma |
| Pemetrexed disodium for injectionPemetrexed disodium is a multi-target antifolate antineoplastic drug. | Drug | Non-scaly and non-small cells lung cancer |
| Cisplatin injectionCisplatin is a chemotherapy drug. | Drug | Non-scaly and non-small cells lung cancer |
Primary outcome
Objective response rate
Time frame: Baseline up to 96 weeks
Proportion of subjects achieving complete and partial response
2 secondary outcomes
The incidence of Adverse events (AE)
Time frame: Baseline up to 96 weeks
The severity of Adverse events (AE)
Time frame: Baseline up to 96 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TQB2450 injection, AL2846 capsule and Pemetrexed disodium for injection in people with Solid Tumor, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 12 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: Baseline up to 96 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2023.