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Advanced Malignant NeoplasmPhase 1NCT06297642

TQB2928 Injection Combined With Penpulimab in Treatment of Advanced Malignant Tumors.

A Phase 1 study testing TQB2928 injection and Penpulimab in people with Advanced Malignant Neoplasm, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 5 sites 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 will evaluate the safety and efficiency of TQB2928 injection combined with Penpulimab in the treatment of patients with advanced malignant tumors. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Advanced Malignant Neoplasm
What is being tested?
TQB2928 injection and Penpulimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
5 sitesChina
Study dates
24 May 2024to 31 Jul 2024
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects voluntarily participate in this study and sign informed consent;
  • Age: ≥18 years old (when signing the informed consent form); Eastern Cooperative Oncology Group (ECOG) score: 0 or 2 point; The expected survival period exceeds 3 months;
  • Subject population: Histologically and/or cytologically confirmed advanced malignancies, including lymphomas and solid tumors.
  • Relapse or treatment failure after previous standard treatment, or intolerance to standard treatment and no other better treatment options：
  • Adequate treatment with PD-1/PD-L1 (including monotherapy or combination) without remission or disease progression after treatment.
  • Adequate main organs function
  • Female subjects of childbearing age should agree to use contraceptives (such as Intrauterine device, contraceptives or condoms) during the study period and within 6 months after the end of the study; The serum or urine Pregnancy test was negative within 7 days before the study was included, and must be non-lactating subjects; Male participants should agree to use contraception during the study period and within 6 months after the end of the study period.

Who cannot join

  • Tumor disease and history:
  • Nodular lymphocyte dominant Hodgkin's lymphoma or gray area lymphoma.
  • The tumor involves the central nervous system.
  • People with a history of hemophagocytic syndrome or who have been assessed by the investigator as being at suspected risk.
  • Has experienced or currently suffers from other malignant tumors within 3 years.
  • Previous anti-tumor therapy:
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  • Previous use of other similar drugs.
  • received systemic antitumor drugs (including drugs under investigation) within 4 weeks prior to initial administration, or received Chimeric Antigen Receptor T-cell (CAR-T) Therapy or Autologous hematopoietic stem cell transplantation( auto-HSCT) within 3 months prior to initial administration.
  • Previously received allogeneic hematopoietic stem cell transplantation (allo-HSCT).
  • any major surgical procedure, chemotherapy and/or radiotherapy, immunotherapy, or targeted therapy within 4 weeks prior to initial dosing.
  • Less than 5 drug half-lives between the first administration and the previous oral targeted therapy (calculated from the end time of the last therapy).
  • Received within 2 weeks before the first administration of Chinese patent drugs (including compound cantharides capsule, Kangai injection, Kanglaite capsule/injection, Aidi injection, Brucea oil injection/capsule, Xiaoaiping tablet/injection, cinobufagin capsule, etc.) approved by the National Drug Administration (NMPA) with anti-tumor indications.
  • Concomitant diseases and medical history:
  • Liver abnormalities:
  • Abnormal kidney:
  • Cardiovascular and cerebrovascular abnormalities:
  • History of immune deficiency:
  • Lung diseases:
  • Active bacterial, fungal, or viral infections requiring systemic treatment.
  • Subjects with a history of hemolytic anemia from any cause (including Evans syndrome) or a positive Coombs test within 3 months prior to initial dosing.
  • A prior history of unexplained severe allergies, known to be allergic to monoclonal drugs or exogenous human immunoglobulins.
  • with a serious or poorly controlled disease that, in the judgment of the investigator and sponsor, poses a serious risk to the safety of the subjects or affects the completion of the study.
  • History of drug abuse or drug use.
  • Live attenuated vaccines were administered within 4 weeks before the first dose or during the planned study period. Inactivated Corona Virus Disease 2019 (COVID-19) and influenza vaccines are allowed.
  • Subjects with concomitant diseases that, in the judgment of the investigator, seriously endanger the safety of the subjects or affect the completion of the study, or subjects who are not suitable for enrollment for other reasons.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

China5 sites

  • Cancer Hospital Chinese Academy of Medical Science

    Beijing, Beijing Municipality, 100021

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510000

  • The Second People's Hospital of Hefei

    Hefei, Anhui, 230012

  • Gansu Provincial Cancer Hospital

    Lanzhou, Gansu, 730000

  • Lu'an People's Hospital of Anhui Province

    Lu'an, Anhui, 237008

Other trials in China

About this study

Official title: A Phase Ib Clinical Trial of TQB2928 Injection Combined With Penpulimab in the Treatment of Patients With Advanced Malignant Tumors.

This study will evaluate the safety and efficiency of TQB2928 injection combined with Penpulimab in the treatment of patients with advanced malignant tumors.

Being tested
TQB2928 injection, Penpulimab

What participants receive

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

  • TQB2928 injectionDrug

    Anti-CD47 monoclonal antibody

  • PenpulimabDrug

    Humanized Monoclonal Antibody to Programmed Cell Death Protein 1 (PD-1)

Study groups in NCT06297642
Study groupRoleWhat they receive
TQB2928 injection + PenpulimabExperimentalTQB2928 injection combined with Penpulimab, 21 days as a treatment cycle.
Receives: Drug: TQB2928 injection; Drug: Penpulimab

What is being measured

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

  1. Dose limiting toxicity (DLT)

    The relevant adverse reactions occurred within the first cycle

    Measured: Baseline up to 3 weeks

  2. 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

Secondary outcomes (14)

  1. Objective response rate (ORR)

    Percentage of participants achieve complete response and partial response

    Measured: Baseline up to 96 weeks

  2. Complete response rate (CRR)

    Percentage of participants achieve complete response

    Measured: Baseline up to 96 weeks

  3. Disease Control Rate

    It is the proportion of patients whose tumors have shrunk or stabilized for a certain amount of time and includes complete response (CR), partial response (PR), and stable (SD) cases

    Measured: Baseline up to 96 weeks

  4. Duration of Response

    The time when the participants first achieved CR or PR to disease progression or death from any cause

    Measured: Baseline up to 96 weeks

  5. Progression-free Survival

    The period between the beginning of treatment and the observation of disease progression or death from any cause in a patient with a tumor disease

    Measured: Baseline up to 96 weeks

  6. Overall survival (OS)

    From the first injection to the time of death from any cause.

    Measured: Baseline up to 96 weeks

  7. Incidence of Anti-Drug antibody

    The incidence of anti-drug antibody after administration of TQB2928 injection and penpulimab

    Measured: Cycle 1 day 1, Cycle 5 day 1, and 28 days, 90 days after the last administration. (Each cycle 21 days)

  8. Incidence of neutralizing antibodies

    The incidence of neutralizing antibodies after administration of TQB2928 injection and penpulimab

    Measured: Cycle 1 day 1, Cycle 5 day 1, and 28 days, 90 days after the last administration. (Each cycle 21 days)

  9. Peak time (Tmax)

    The time to peak concentration

    Measured: Day 1, day 2 , day 4 , day 6 , day 8, day15 of cycle 1 and cycle 2. Each cycle 21 days.

  10. Peak concentration (Cmax)

    Maximum plasma drug concentration

    Measured: Day 1, day 2 , day 4 , day 6 , day 8, day15 of cycle 1 and cycle 2. Each cycle 21 days.

  11. The area under the plasma concentration time curve from zero to after 24h (AUC0-24h)

    Area under the plasma concentration time curve from zero to after 24h for TQB2928.

    Measured: Day 1, day 2 , day 4 , day 6 , day 8, day15 of cycle 1 and cycle 2. Each cycle 21 days.

  12. Steady-state apparent volume of distribution (Vz/F)

    The total volume of body fluid required by the measured plasma drug concentration after the total amount of drug in the body is to be balanced.

    Measured: Day 1, day 2 , day 4 , day 6 , day 8, day15 of cycle 1 and cycle 2. Each cycle 21 days.

  13. Minimum plasma concentration at steady state (Cmin,ss)

    The minimum plasma concentration after stabilization

    Measured: Day 1, day 2 , day 4 , day 6 , day 8, day15 of cycle 1 and cycle 2. Each cycle 21 days.

  14. Receptor Occupancy (RO%)

    The extent to which antibody drugs occupy cell surface targets

    Measured: day 1 and day 8 of Cycle 1, day 1 and day 15 of Cycle 2, 28 days after the last administration. (each cycle 21 days)

Timeline

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

  1. First posted7 Mar 2024
  2. Study start24 May 2024
  3. Primary completion31 Jul 2024
  4. Study completion31 Jul 2024

Why it stopped: Based on the current status of the same target research and the company's overall layout in the field of tumors, the early termination was determined after full communication with the principal investigator of the group leader unit.

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
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06297642
Sponsor's protocol ID
TQB2928-AK105-Ib-01
Status last verified
Jan 2024
First submitted
1 Mar 2024
Last updated
6 Aug 2024
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 TQB2928 injection and Penpulimab in people with Advanced Malignant Neoplasm, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 5 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 7 inclusion and 25 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 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 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: Based on the current status of the same target research and the company's overall layout in the field of tumors, the early termination was determined after full communication with the principal investigator of the group leader unit.). 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 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 NCT06297642.

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 6 Aug 2024.

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