A Clinical Trial to Evaluate Tolerability and Security of TQB2858 Injection in Subjects With Advanced Pancreatic Carcinoma

NCT05193604 | Terminated Phase 1

• 1 other identifier: TQB2858-I-02
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

This study is divided into three phases: single-dose exploration, combination dosage exploration and cohort expansion. The Single-dose exploration stage aims to evaluate the tolerability of TQB2858 injection in subjects with advanced pancreatic carcinoma. The Combination dosage exploration stage aims to evaluate the tolerance of TQB2858 injection combined with chemotherapy in patients with metastatic pancreatic cancer. The cohort expansion phase aims to evaluate the preliminary efficacy of TQB2858 injection combined with gemcitabine, albumin paclitaxel, and with or without anlotinib in patients with metastatic pancreatic cancer，and to explore treatment-related biomarkers.

Conditions

Pancreatic Carcinoma

Outcome Measures

Primary Outcomes (3)

• Dose limiting toxicity (DLT)

  Grade 3 or 4 adverse events related to the study drug that occurred during cycle 1

  Baseline up to 3 weeks

• Recommended phase II dose (RP2D)

  Recommended dose for phase II

  Baseline up to 3 weeks

• Overall response rate (ORR)

  ORR refers to the percentage of complete response (CR) or partial response (PR) subjects determined by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or iRECIST (CR and PR under iRECIST criteria can occur after imaging disease progression).

  Baseline up to 30 weeks

Secondary Outcomes (5)

• Adverse event rate

  Baseline up to 96 weeks

• Disease control rate (DCR)

  Baseline up to 30 weeks

• Duration of Response (DOR)

  Baseline up to 30 weeks

• Progression-Free Survival (PFS)

  Baseline up to 30 weeks

• Overall survival (OS)

  Baseline up to 96 weeks

Study Arms (1)

TQB2858 injection

EXPERIMENTAL

Cohort 1: TQB2858 injection administered intravenously on day 1 of each 21-day cycle. Cohort 2: TQB2858 injection administered intravenously on day 1 of each 21-day cycle, gemcitabine and albumin paclitaxel administered intravenously on day 1 and day 7 of each 21-day cycle. Cohort 3: TQB2858 injection administered intravenously on day 1 of each 21-day cycle，gemcitabine and albumin paclitaxel administered intravenously on day 1 and day 7 of each 21-day cycle，Anlotinib capsules 8 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).

Drug: TQB2858 injection; Drug: Anlotinib Hydrochloride Capsule; Drug: Gemcitabine hydrochloride for injection; Drug: Paclitaxel for injection (albumin bound)

Interventions

TQB2858 injection DRUG

TQB2858 injection is a programmed cell death 1 ligand 1 (PD-L1)/transforming growth factor-β bispecific antibody.

TQB2858 injection

Anlotinib Hydrochloride Capsule DRUG

Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor.

TQB2858 injection

Gemcitabine hydrochloride for injection DRUG

Chemotherapy medicine for metastatic pancreatic cancer

TQB2858 injection

Paclitaxel for injection (albumin bound) DRUG

Chemotherapy medicine for metastatic pancreatic cancer

TQB2858 injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients voluntarily joined the study and signed the informed consent；
• \. Aged: 18 \~ 75 years old；
• \. Phase 1:patients who have failed to receive at least 1 line of system chemotherapy in the past or the investigator believes that they are not suitable for receiving systemic chemotherapy; The first cohort and second cohort of Phase 2 and of Phase 3: newly diagnosed patients with metastatic pancreatic cancer confirmed by tissue or cytology; The third cohort of Phase 3: patients with metastatic pancreatic cancer who have undergone first-line FOLFIRINOX or FOLFIRINOX+BRCA mutation targeted therapy or PD-1/PD-L1 treatment failure;
• \. Confirmed to have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumours (RECIST) 1.1
• \. Physical condition score( Eastern Cooperative Oncology Group(ECOG) score): 0\~1，estimated survival time ≥ 3 months；
• \. The main organs are functioning normally；
• \. Women of childbearing age must be negative for serum or urine human chorionic gonadotropin (HCG) within 7 days prior to study enrollment and must be non-lactating; Patients should agree to use contraception during the study period and for 6 months after the study period；

You may not qualify if:

• (1) Concomitant disease and medical history:
• Unmitigated toxic reactions above the Common Terminology Criteria for Adverse Events (CTCAE) grade 1 due to any prior treatment, excluding hair loss and peripheral sensory nerve disorders;;
• Severe organ failure;
• Has developed other malignant tumors within 5 years or is currently suffering from the same tumor;
• Received major surgical treatment or significant traumatic injury (excluding needle biopsy) within 28 days prior to the commencement of study treatment;
• Long-term unhealed wounds or fractures;
• Active bleeding or researchers believe that the risk of bleeding is higher;
• The occurrence of arterial/venous thrombosis events within 6 months, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism;
• People with a history of psychotropic substance abuse and inability to quit or with mental disorders;
• Symptomatic interstitial lung disease, and conditions that may cause drug pulmonary toxicity or related pneumonia;
• Subjects with any severe and/or uncontrolled disease;
• (2) Tumor-related symptoms and treatment:
• Had undergone surgery, chemotherapy, radiation or other anticancer therapy within 4 weeks prior to the start of study treatment (washout period was calculated from the end of the last treatment);
• Computed tomography (CT) or Magnetic resonance imaging (MRI) shows that the tumor has invaded important blood vessels or the investigator has determined that the tumor is likely to invade important blood vessels and cause fatal hemorrhage during the follow-up study;
• Patients with brain metastases whose symptoms stabilized less than 4 weeks after discontinuation of dehydrants and steroids;

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Injections; Paclitaxel

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Drug Administration Routes; Drug Therapy; Therapeutics; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2021
• First Posted: January 18, 2022
• Study Start: March 24, 2022
• Primary Completion: November 27, 2023
• Study Completion: November 27, 2023
• Last Updated: December 8, 2023

Record last verified: 2023-01

Locations

CN (1)