A Phase Ib Clinical Trial to Evaluate the Safety and Efficacy of TQB2450 Injection Combined With AL2846 Capsules in Patients With Advanced Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- TQB2450 injection
- Conditions
- Solid Tumor
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Enrollment
- 135
- Locations
- 12
- Primary Endpoint
- Objective response rate
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
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:
- •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:
- •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:
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.);
Arms & Interventions
Subjects with advanced hepatocellular carcinoma
TQB2450 injection, 21 days as a treatment cycle. AL2846 capsule, 21 days as a treatment cycle.
Intervention: TQB2450 injection
Subjects with advanced hepatocellular carcinoma
TQB2450 injection, 21 days as a treatment cycle. AL2846 capsule, 21 days as a treatment cycle.
Intervention: AL2846 capsule
Advanced gastric adenocarcinoma / gastroesophageal junction adenocarcinoma subjects
TQB2450 injection, 21 days as a treatment cycle. AL2846 capsule, 21 days as a treatment cycle.
Intervention: TQB2450 injection
Advanced gastric adenocarcinoma / gastroesophageal junction adenocarcinoma subjects
TQB2450 injection, 21 days as a treatment cycle. AL2846 capsule, 21 days as a treatment cycle.
Intervention: AL2846 capsule
Advanced non-small cell lung cancer
TQB2450 injection, 21 days as a treatment cycle. AL2846 capsule, 21 days as a treatment cycle.
Intervention: TQB2450 injection
Advanced non-small cell lung cancer
TQB2450 injection, 21 days as a treatment cycle. AL2846 capsule, 21 days as a treatment cycle.
Intervention: AL2846 capsule
Locally advanced or metastatic urothelial cancer
TQB2450 injection, 21 days as a treatment cycle. AL2846 capsule, 21 days as a treatment cycle.
Intervention: TQB2450 injection
Locally advanced or metastatic urothelial cancer
TQB2450 injection, 21 days as a treatment cycle. AL2846 capsule, 21 days as a treatment cycle.
Intervention: AL2846 capsule
Advanced esophageal squamous cell carcinoma
TQB2450 injection, 21 days as a treatment cycle. AL2846 capsule, 21 days as a treatment cycle.
Intervention: TQB2450 injection
Advanced esophageal squamous cell carcinoma
TQB2450 injection, 21 days as a treatment cycle. AL2846 capsule, 21 days as a treatment cycle.
Intervention: AL2846 capsule
Non-scaly and non-small cells lung cancer
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.
Intervention: TQB2450 injection
Non-scaly and non-small cells lung cancer
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.
Intervention: AL2846 capsule
Non-scaly and non-small cells lung cancer
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.
Intervention: Pemetrexed disodium for injection
Non-scaly and non-small cells lung cancer
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.
Intervention: Cisplatin injection
Outcomes
Primary Outcomes
Objective response rate
Time Frame: Baseline up to 96 weeks
Proportion of subjects achieving complete and partial response
Secondary Outcomes
- The incidence of Adverse events (AE)(Baseline up to 96 weeks)
- The severity of Adverse events (AE)(Baseline up to 96 weeks)