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Soft Tissue SarcomaPhase 2NCT06500091

TQB2916 Injection Combined With Chemotherapy or Penpulimab Injection in the Treatment of Solid Tumors

A Phase 2 study testing TQB2916 injection + doxorubicin hydrochloride for injection and TQB2916 injection+penpulimab injection in people with Soft Tissue Sarcoma and Melanoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 11 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This project is a clinical trial on the efficacy and safety of TQB2916 injection combined with chemotherapy or penpulimab injection in solid tumors. This project is divided into two cohorts. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Soft Tissue Sarcoma, Melanoma
What is being tested?
TQB2916 injection + doxorubicin hydrochloride for injection and TQB2916 injection+penpulimab injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
11 sitesChina
Study dates
Jul 2024to Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • The subjects voluntarily joined this study, signed an informed consent form, and had good compliance.
  • Age: 18-75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0-1 points; The expected survival period exceeds 3 months.
  • Patients with locally advanced or unresponsive relapsed/metastatic soft tissue sarcoma and melanoma diagnosed by pathology and unable or refused surgery. Cohort 1contains the following subtypes: "dedifferentiated liposarcoma, highly differentiated liposarcoma with dedifferentiated components, leiomyosarcoma (excluding uterine leiomyosarcoma)", and cohort 2 contains undifferentiated pleomorphic sarcoma and melanoma.
  • Cohort 1: No previous history of failure of anthracycline-based chemotherapy. Cohort 2: Previously treated with standard of care.
  • Cohort 2: Previously treated.
  • According to RECIST 1.1 standard, it is confirmed that there is at least one measurable lesion.
  • The main organs are functioning well.
  • Female participants of childbearing age should agree to use contraceptive measures during the study period and within 6 months after the end of the study; Within 7 days prior to enrollment, the serum pregnancy test was negative and must be a non lactating subject; Male participants should agree to use contraceptive measures during the study period and within 6 months after the end of the study period.

Who cannot join

  • Concomitant diseases and medical history:
  • Has experienced or currently suffers from other malignant tumors within 5 years.
  • Unresolved toxic reactions above CommonTerminology Criteria for Adverse Events level 1 caused by any previous treatment;
  • The research treatment began with significant surgical treatment, open biopsy, or obvious traumatic injury;
  • Long term unhealed wounds or fractures;
  • Arterial/venous thrombotic events that have occurred within 6 months and affect current normal function;
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  • Individuals with a history of psychiatric drug abuse who are unable to quit or have mental disorders;
  • Individuals who have previously undergone splenectomy or received splenic radiotherapy within 3 months prior to enrollment;
  • Currently present with congenital hemorrhagic or coagulation diseases, or currently undergoing treatment with warfarin;
  • Subjects with any severe and/or uncontrolled diseases, including:
  • Blood pressure control is still not ideal after dual drug treatment;
  • Suffering from ≥ grade 2 myocardial ischemia or myocardial infarction, arrhythmia; ≥ Grade 2 unstable angina pectoris;
  • Active or uncontrolled severe infection or unexplained fever>38.5 °C;
  • Cirrhosis and active hepatitis *;
  • Active syphilis patients;
  • Renal failure requiring hemodialysis or peritoneal dialysis;
  • Have a history of immunodeficiency;
  • Poor control of diabetes;
  • Urinary routine indicates urine protein ≥++;
  • Individuals with epilepsy who require treatment;
  • Weight<40 kg and BMI<18.5 kg/m2, or weight loss of ≥ 10% within 3 months.
  • Tumor related symptoms and treatment:
  • Has received surgery, chemotherapy, radiation therapy, or other anti-cancer therapies before the start of the research treatment;
  • Before the start of the study treatment, he received the treatment of traditional Chinese patent medicines and simple preparations with anti-tumor indications specified in the National MedicalProducts Administration (NMPA) approved drug directions;
  • Cohort 1: Previously used doxorubicin exceeding 200mg/m2;
  • Cohort 2: Undifferentiated multidirectional sarcoma that has previously received more than 2 types of anti vascular tyrosine kinase inhibitors (TKIs), or has previously received relevant immunotherapy drugs;
  • Previously received antibodies or fusion proteins targeting CD40;
  • Imaging shows that the tumor invades large blood vessels or has unclear boundaries with large blood vessels, or the researcher determines that the tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during subsequent studies;
  • Uncontrollable pleural effusion, pericardial effusion, or ascites that still require repeated drainage;
  • Severe bone damage caused by tumor bone metastasis may occur in the presence or after enrollment;
  • Uncontrollable pain related to tumor bone metastasis;
  • There was central nervous system metastasis before enrollment.
  • Research and treatment related:
  • History of live attenuated vaccine administration before the start of research treatment or planned live attenuated vaccine administration during the study period;
  • There is a clear bleeding tendency or clinically significant bleeding symptoms before the first use of medication;
  • Individuals who have experienced severe hypersensitivity reactions after using monoclonal antibodies, or who are allergic to known components of the investigational drug;
  • Active autoimmune diseases that require systemic treatment have occurred within 2 years prior to the start of the research treatment.
  • Diagnosed with immunodeficiency or undergoing systemic glucocorticoid therapy or any other form of immunosuppressive therapy.
  • Participated in clinical trials of other anti-tumor drugs within the first 4 weeks of grouping.
  • According to the researcher's judgment, there are individuals with accompanying diseases that seriously endanger the safety of the subjects or affect the completion of the study, or individuals who are deemed unsuitable for enrollment due to other reasons.

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jilong Yang, Doctor contact

18622221626

yangjilong@tjmuch.com

Yong Chen, Doctor contact

18017317571

chenyong@shca.org.cn

11 sites in 1 country

China11 sites

  • Cancer Hospital Chinese Academy of Medical Science

    Beijing, Beijing Municipality, 100021

    Helin Feng, Doctor, 18900189633, fenghelin0311@126.com

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Jiayong Liu, Doctor, 13641103227, liujiayong@aliyun.com

  • Jilin Cancer Hospital

    Changchun, Jilin, 130012

    Yanling Liu, Bachelor, 13500891447, 1301878994@qq.com

  • Hunan Cancer Hospital

    Changsha, Hunan, 410000

    Xianan Li, Doctor, 18874933879, Lixianan2001@163.com

  • Zhe Jiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

    Meiyu Fang, Doctor, 13750851650, fangmy@zjcc.org.cn

  • Cancer Hospital Affiliated to Shandong First Medical University

    Jinan, Shandong, 250117

    Dongyuan Zhu, Doctor, 18954516655, 405683898@qq.com

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Yong Chen, Doctor, 18017317571, chenyong@shca.org.cn

  • Shanxi Cancer Hospital

    Taiyuan, Shanxi, 030000

    Yuxia Shi, Bachelor, 15835108188, 1274174089@qq.com

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

    Jilong Yang, Doctor, 18622221626, yangjilong@tjmuch.com

  • Xinjiang Medical University Affiliated Cancer Hospital

    Ürümqi, Xinjiang, 830000

    Renbing Jiang, Doctor, 13999153829, 1911452679@qq.com

  • Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University

    Zhengzhou, Henan, 450000

    Weitao Yao, Doctor, 13298189535, ywtwhm@163.com

Other trials in China

About this study

Official title: A Multicenter, Open-Label, Single-Arm, Multi-Cohort Phase II Clinical Trial Evaluating the Efficacy and Safety of TQB2916 Injection in Combination With Chemotherapy or in Combination With Penpulimab Injection for Solid Tumors

This project is a clinical trial on the efficacy and safety of TQB2916 injection combined with chemotherapy or penpulimab injection in solid tumors. This project is divided into two cohorts. Cohort 1 aims to explore the safety and efficacy of specific subtypes of soft tissue sarcoma in subjects; Cohort 2 aims to explore safety and efficacy in subjects with undifferentiated pleomorphic sarcoma and melanoma. A total of 54 subjects are planned to be enrolled in this project.

Being tested
TQB2916 injection + doxorubicin hydrochloride for injection, TQB2916 injection+penpulimab injection
Medical subject headings
Sarcoma, Melanoma

What participants receive

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

  • TQB2916 injection + doxorubicin hydrochloride for injectionDrug

    TQB2916 is a humanized immune gamma globulins 2 (IgG2) monoclonal antibody targeting CD40.

    The mechanism of action of doxorubicin is mainly to destroy the DNA structure of tumor cells, thereby killing malignant tumors. It interferes with the DNA synthesis process of cancer cells by targeting DNA and inhibiting enzymes in DNA replication and repair. In addition, doxorubicin can also trigger cross-link breaks in DNA, leading to apoptosis of cancer cells.

  • TQB2916 injection+penpulimab injectionDrug

    TQB2916 is a humanized IgG2 monoclonal antibody targeting CD40. Penpulimab injection is a programmed cell death protein 1 (PD-1) immune checkpoint inhibitor.

Study groups in NCT06500091
Study groupRoleWhat they receive
TQB2916 injection + doxorubicin hydrochloride for injectionExperimentalTQB2916 injection + doxorubicin hydrochloride for injection, 21 days as a treatment cycle.
Receives: Drug: TQB2916 injection + doxorubicin hydrochloride for injection
TQB2916 injection+penpulimab injectionExperimentalTQB2916 injection+penpulimab injection , 21 days as a treatment cycle.
Receives: Drug: TQB2916 injection+penpulimab injection

What is being measured

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

  1. Overall response rate (ORR)

    Objective response rate 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 modified RECIST 1.1 for immune based therapeutics(guidelines for response criteria for use in trials testing Immunotherapeutics（iRECIST)) (CR and PR) under iRECIST criteria can occur after imaging disease progression).

    Measured: Up to 48 weeks

  2. 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: Up to 48 weeks

Secondary outcomes (2)

  1. Overall survival (OS)

    Overall survival defined as the time from enrollment to death from any cause.

    Measured: Up to 2 years

  2. 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: Up to 48 weeks

Timeline

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

  1. First posted15 Jul 2024
  2. Study startJul 2024 (estimated)
  3. Primary completionJun 2026 (estimated)
  4. Study completionDec 2026 (estimated)

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06500091
Sponsor's protocol ID
TQB2916-AK105-II-01
Status last verified
Oct 2023
First submitted
8 Jul 2024
Last updated
15 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TQB2916 injection + doxorubicin hydrochloride for injection and TQB2916 injection+penpulimab injection in people with Soft Tissue Sarcoma and Melanoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 11 sites 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 8 inclusion and 40 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: opening soon, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Jilong Yang, Doctor (18622221626, yangjilong@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (ORR) (time frame: Up to 48 weeks). The study lists 2 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 NCT06500091.

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 15 Jul 2024.

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