NCT06116240

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
135

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

12 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 2, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 3, 2023

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

November 3, 2023

Status Verified

October 1, 2023

Enrollment Period

1.2 years

First QC Date

October 31, 2023

Last Update Submit

October 31, 2023

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

  • Objective response rate

    Proportion of subjects achieving complete and partial response

    Baseline up to 96 weeks

Secondary Outcomes (2)

  • The incidence of Adverse events (AE)

    Baseline up to 96 weeks

  • The severity of Adverse events (AE)

    Baseline up to 96 weeks

Study Arms (6)

Subjects with advanced hepatocellular carcinoma

EXPERIMENTAL

TQB2450 injection, 21 days as a treatment cycle. AL2846 capsule, 21 days as a treatment cycle.

Drug: TQB2450 injectionDrug: 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.

Drug: TQB2450 injectionDrug: 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.

Drug: TQB2450 injectionDrug: 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.

Drug: TQB2450 injectionDrug: AL2846 capsule

Advanced esophageal squamous cell carcinoma

EXPERIMENTAL

TQB2450 injection, 21 days as a treatment cycle. AL2846 capsule, 21 days as a treatment cycle.

Drug: TQB2450 injectionDrug: 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.

Drug: TQB2450 injectionDrug: AL2846 capsuleDrug: Pemetrexed disodium for injectionDrug: Cisplatin injection

Interventions

TQB2450 injectionDRUG

TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1).

Advanced esophageal squamous cell carcinomaAdvanced gastric adenocarcinoma / gastroesophageal junction adenocarcinoma subjectsAdvanced non-small cell lung cancerLocally advanced or metastatic urothelial cancerNon-scaly and non-small cells lung cancerSubjects with advanced hepatocellular carcinoma
AL2846 capsuleDRUG

AL2846 is a multi-targeted tyrosine kinase receptor inhibitor

Advanced esophageal squamous cell carcinomaAdvanced gastric adenocarcinoma / gastroesophageal junction adenocarcinoma subjectsAdvanced non-small cell lung cancerLocally advanced or metastatic urothelial cancerNon-scaly and non-small cells lung cancerSubjects with advanced hepatocellular carcinoma
Pemetrexed disodium for injectionDRUG

Pemetrexed disodium is a multi-target antifolate antineoplastic drug.

Non-scaly and non-small cells lung cancer
Cisplatin injectionDRUG

Cisplatin is a chemotherapy drug.

Non-scaly and non-small cells lung cancer

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • 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;
  • +2 more criteria

You may not qualify if:

  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

Jiangmen Central Hospital

Jiangmen, Guangdong, 529000, China

Location

Affiliated Hospital of Hebei University

Baoding, Hebei, 071002, China

Location

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

Location

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, 471003, China

Location

Inner Mongolia Baotou Steel Hospital

Baotou, Neimenggu, 014010, China

Location

Shandong First Medical University Affiliated Cancer Hospital

Jinan, Shandong, 250117, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300040, China

Location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300070, China

Location

The Second Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, 300211, China

Location

Tianjin Chest Hospital

Tianjin, Tianjin Municipality, 300222, China

Location

Tianjin Fifth Central Hospital

Tianjin, Tianjin Municipality, 300450, China

Location

MeSH Terms

Interventions

PemetrexedInjectionsCisplatin

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DicarboxylicDrug Administration RoutesDrug TherapyTherapeuticsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2023

First Posted

November 3, 2023

Study Start

September 2, 2022

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

November 3, 2023

Record last verified: 2023-10

Locations

CN(12)