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

Primary Purpose

Pancreatic Carcinoma

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
TQB2858 injection
Anlotinib Hydrochloride Capsule
Gemcitabine hydrochloride for injection
Paclitaxel for injection (albumin bound)
Sponsored by
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1. Patients voluntarily joined the study and signed the informed consent;
  • 2. Aged: 18 ~ 75 years old;
  • 3. 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;
  • 4. Confirmed to have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumours (RECIST) 1.1
  • 5. Physical condition score( Eastern Cooperative Oncology Group(ECOG) score): 0~1,estimated survival time ≥ 3 months;
  • 6. The main organs are functioning normally;
  • 7. 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;

Exclusion Criteria:

  • (1) Concomitant disease and medical history:

    1. 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;;
    2. Severe organ failure;
    3. Has developed other malignant tumors within 5 years or is currently suffering from the same tumor;
    4. Received major surgical treatment or significant traumatic injury (excluding needle biopsy) within 28 days prior to the commencement of study treatment;
    5. Long-term unhealed wounds or fractures;
    6. Active bleeding or researchers believe that the risk of bleeding is higher;
    7. 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;
    8. People with a history of psychotropic substance abuse and inability to quit or with mental disorders;
    9. Symptomatic interstitial lung disease, and conditions that may cause drug pulmonary toxicity or related pneumonia;
    10. Subjects with any severe and/or uncontrolled disease;
  • (2) Tumor-related symptoms and treatment:

    1. 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);
    2. 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;
    3. Patients with brain metastases whose symptoms stabilized less than 4 weeks after discontinuation of dehydrants and steroids;
  • (3) Research Treatment Related:

    1. Previous history of severe allergy to macromolecular drugs or known components of TQB2858 injection;
    2. Participants had participated in other antitumor drug clinical trials in the previous 4 weeks;
    3. Have been diagnosed with immunodeficiency or are receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy (dose of >10mg/ day prednisone or other equivalent efficacy hormone), and continued to use within 2 weeks of the first administration;
    4. A history of live attenuated vaccine vaccination within 28 days prior to the study treatment initiation or a planned live attenuated vaccine vaccination during the study period;
    5. Study the occurrence of active autoimmune disease requiring systemic treatment (e.g., use of palliative drugs, corticosteroids, or immunosuppressants) within 2 years prior to treatment initiation;
  • (4) Participated in other anti-tumor drug clinical trials within 4 weeks before the first medication or less than 5 drug half-lives;
  • (5) Subject who, in the Investigator's judgment, has a concomitant disease that seriously endangers the subject's safety or affects the completion of the study, or is considered unsuitable for inclusion for other reasons;

Sites / Locations

  • The First Affiliated Hospital, Zhejiang University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TQB2858 injection

Arm Description

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).

Outcomes

Primary Outcome Measures

Dose limiting toxicity (DLT)
Grade 3 or 4 adverse events related to the study drug that occurred during cycle 1
Recommended phase II dose (RP2D)
Recommended dose for phase II
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).

Secondary Outcome Measures

Adverse event rate
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Disease control rate (DCR)
DCR refers to the percentage of subjects with CR, PR, or stable disease (SD) of 6 weeks or more as determined by RECIST 1.1 or iRECIST (CR, PR, SD under iRECIST criteria can occur after imaging disease progression).
Duration of Response (DOR)
DOR will be defined as median number of months from date of first documented objective response until first documented sign of disease progression or death due to any causes.
Progression-Free Survival (PFS)
PFS will be defined as median number of months from the date of randomization until the first documented sign of disease progression or death due to any causes, whichever occurs first.
Overall survival (OS)
From randomization to the time of death from any cause.

Full Information

First Posted
December 28, 2021
Last Updated
November 2, 2022
Sponsor
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05193604
Brief Title
A Clinical Trial to Evaluate Tolerability and Security of TQB2858 Injection in Subjects With Advanced Pancreatic Carcinoma
Official Title
Phase I Clinical Trial to Evaluate the Tolerability and Safety of TQB2858 Injection in Subjects With Metastatic Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 24, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TQB2858 injection
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
TQB2858 injection
Intervention Description
TQB2858 injection is a programmed cell death 1 ligand 1 (PD-L1)/transforming growth factor-β bispecific antibody.
Intervention Type
Drug
Intervention Name(s)
Anlotinib Hydrochloride Capsule
Intervention Description
Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine hydrochloride for injection
Intervention Description
Chemotherapy medicinae for metastatic pancreatic cancer
Intervention Type
Drug
Intervention Name(s)
Paclitaxel for injection (albumin bound)
Intervention Description
Chemotherapy medicinae for metastatic pancreatic cancer
Primary Outcome Measure Information:
Title
Dose limiting toxicity (DLT)
Description
Grade 3 or 4 adverse events related to the study drug that occurred during cycle 1
Time Frame
Baseline up to 3 weeks
Title
Recommended phase II dose (RP2D)
Description
Recommended dose for phase II
Time Frame
Baseline up to 3 weeks
Title
Overall response rate (ORR)
Description
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).
Time Frame
Baseline up to 30 weeks
Secondary Outcome Measure Information:
Title
Adverse event rate
Description
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Time Frame
Baseline up to 96 weeks
Title
Disease control rate (DCR)
Description
DCR refers to the percentage of subjects with CR, PR, or stable disease (SD) of 6 weeks or more as determined by RECIST 1.1 or iRECIST (CR, PR, SD under iRECIST criteria can occur after imaging disease progression).
Time Frame
Baseline up to 30 weeks
Title
Duration of Response (DOR)
Description
DOR will be defined as median number of months from date of first documented objective response until first documented sign of disease progression or death due to any causes.
Time Frame
Baseline up to 30 weeks
Title
Progression-Free Survival (PFS)
Description
PFS will be defined as median number of months from the date of randomization until the first documented sign of disease progression or death due to any causes, whichever occurs first.
Time Frame
Baseline up to 30 weeks
Title
Overall survival (OS)
Description
From randomization to the time of death from any cause.
Time Frame
Baseline up to 96 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Patients voluntarily joined the study and signed the informed consent; 2. Aged: 18 ~ 75 years old; 3. 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; 4. Confirmed to have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 5. Physical condition score( Eastern Cooperative Oncology Group(ECOG) score): 0~1,estimated survival time ≥ 3 months; 6. The main organs are functioning normally; 7. 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; Exclusion Criteria: (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; (3) Research Treatment Related: Previous history of severe allergy to macromolecular drugs or known components of TQB2858 injection; Participants had participated in other antitumor drug clinical trials in the previous 4 weeks; Have been diagnosed with immunodeficiency or are receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy (dose of >10mg/ day prednisone or other equivalent efficacy hormone), and continued to use within 2 weeks of the first administration; A history of live attenuated vaccine vaccination within 28 days prior to the study treatment initiation or a planned live attenuated vaccine vaccination during the study period; Study the occurrence of active autoimmune disease requiring systemic treatment (e.g., use of palliative drugs, corticosteroids, or immunosuppressants) within 2 years prior to treatment initiation; (4) Participated in other anti-tumor drug clinical trials within 4 weeks before the first medication or less than 5 drug half-lives; (5) Subject who, in the Investigator's judgment, has a concomitant disease that seriously endangers the subject's safety or affects the completion of the study, or is considered unsuitable for inclusion for other reasons;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tingbo Liang, Doctor
Phone
0571-87236688
Email
liangtingbo@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xueli Bai, Doctor
Phone
0571-87236857
Email
shirleybai@zju.edu.cn
Facility Information:
Facility Name
The First Affiliated Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xueli Bai, Doctor
Phone
0571-87236857
Email
shirleybai@zju.edu.cn

12. IPD Sharing Statement

Learn more about this trial

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

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