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Pancreatic CarcinomaPhase 1NCT05193604

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

A Phase 1 study testing TQB2858 injection, Anlotinib Hydrochloride Capsule and Gemcitabine hydrochloride for injection in people with Pancreatic Carcinoma, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pancreatic Carcinoma
What is being tested?
TQB2858 injection, Anlotinib Hydrochloride Capsule and Gemcitabine hydrochloride for injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteChina
Study dates
24 Mar 2022to 27 Nov 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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；

Who cannot join

  • (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;
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  • 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；

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310000

Other trials in China

About this study

Official title: Phase I Clinical Trial to Evaluate the Tolerability and Safety of TQB2858 Injection in Subjects With Metastatic Pancreatic Cancer

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.

Being tested
TQB2858 injection, Anlotinib Hydrochloride Capsule, Gemcitabine hydrochloride for injection, Paclitaxel for injection (albumin bound)
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TQB2858 injectionDrug

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

  • Anlotinib Hydrochloride CapsuleDrug

    Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor.

  • Gemcitabine hydrochloride for injectionDrug

    Chemotherapy medicine for metastatic pancreatic cancer

  • Paclitaxel for injection (albumin bound)Drug

    Chemotherapy medicine for metastatic pancreatic cancer

Study groups in NCT05193604
Study groupRoleWhat they receive
TQB2858 injectionExperimentalCohort 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).
Receives: Drug: TQB2858 injection; Drug: Anlotinib Hydrochloride Capsule; Drug: Gemcitabine hydrochloride for injection; Drug: Paclitaxel for injection (albumin bound)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose limiting toxicity (DLT)

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

    Measured: Baseline up to 3 weeks

  2. Recommended phase II dose (RP2D)

    Recommended dose for phase II

    Measured: Baseline up to 3 weeks

  3. 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).

    Measured: Baseline up to 30 weeks

Secondary outcomes (5)

  1. Adverse event rate

    The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).

    Measured: Baseline up to 96 weeks

  2. 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).

    Measured: Baseline up to 30 weeks

  3. 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.

    Measured: Baseline up to 30 weeks

  4. 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.

    Measured: Baseline up to 30 weeks

  5. Overall survival (OS)

    From randomization to the time of death from any cause.

    Measured: Baseline up to 96 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2022
  2. Study start24 Mar 2022
  3. Primary completion27 Nov 2023
  4. Study completion27 Nov 2023

Why it stopped: Terminated due to the adjustment of sponsor's development strategies and pipeline.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05193604
Sponsor's protocol ID
TQB2858-I-02
Status last verified
Jan 2023
First submitted
28 Dec 2021
Last updated
8 Dec 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TQB2858 injection, Anlotinib Hydrochloride Capsule and Gemcitabine hydrochloride for injection in people with Pancreatic Carcinoma, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Terminated due to the adjustment of sponsor's development strategies and pipeline.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limiting toxicity (DLT) (time frame: Baseline up to 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05193604.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.

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