Overview

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

Status:
Not yet recruiting
Trial end date:
2023-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Treatments:
Gemcitabine
Paclitaxel
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:

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;