TerminatedNCT06297642Updated Aug 6, 2024

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

A Phase 1 interventional study of TQB2928 injection and Penpulimab in Advanced Malignant Neoplasm, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. Terminated at 5 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-08-06.

Sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Phase 1, Interventional, and Treatment

Why this study was terminated

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.

Phase: Phase 1
Study type: Interventional
Enrollment: 3
Allocation: Not applicable
Ages: 18 Years to 70 Years
Sex: All

Study summary

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

Conditions studied

Advanced Malignant Neoplasm

Browse trials for

Neoplasms 9,371

In context

Neoplasms

9,371 studies on the registry are indexed under Neoplasms; 2,492 are open to participants now.

This study's enrollment of 3 is below the median of 50 across 7,258 interventional studies indexed under Neoplasms.

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Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd. is the lead sponsor of 313 studies on the registry; 75 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

Tumor disease and history:
1. Nodular lymphocyte dominant Hodgkin's lymphoma or gray area lymphoma.
2. The tumor involves the central nervous system.
3. People with a history of hemophagocytic syndrome or who have been assessed by the investigator as being at suspected risk.
4. Has experienced or currently suffers from other malignant tumors within 3 years.
Previous anti-tumor therapy:
1. Previous use of other similar drugs.
2. 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.
3. Previously received allogeneic hematopoietic stem cell transplantation (allo-HSCT).
4. any major surgical procedure, chemotherapy and/or radiotherapy, immunotherapy, or targeted therapy within 4 weeks prior to initial dosing.
5. 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).
6. 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:
1. Liver abnormalities:
2. Abnormal kidney:
3. Cardiovascular and cerebrovascular abnormalities:
4. History of immune deficiency:
5. Lung diseases:
6. Active bacterial, fungal, or viral infections requiring systemic treatment.
7. 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.
8. A prior history of unexplained severe allergies, known to be allergic to monoclonal drugs or exogenous human immunoglobulins.
9. 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.
10. 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.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 3 participants (actual)

Study arms

Experimental
TQB2928 injection + Penpulimab
TQB2928 injection combined with Penpulimab, 21 days as a treatment cycle.
Drug: TQB2928 injection · Drug: Penpulimab

Interventions

DrugTQB2928 injection
Anti-CD47 monoclonal antibody
DrugPenpulimab
Humanized Monoclonal Antibody to Programmed Cell Death Protein 1 (PD-1)

What researchers measure

Primary outcomes

Dose limiting toxicity (DLT)
The relevant adverse reactions occurred within the first cycle
Time frame: Baseline up to 3 weeks
Adverse event rate
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Time frame: Baseline up to 96 weeks

Secondary outcomes

Objective response rate (ORR)
Percentage of participants achieve complete response and partial response
Time frame: Baseline up to 96 weeks
Complete response rate (CRR)
Percentage of participants achieve complete response
Time frame: Baseline up to 96 weeks
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
Time frame: Baseline up to 96 weeks
Duration of Response
The time when the participants first achieved CR or PR to disease progression or death from any cause
Time frame: Baseline up to 96 weeks
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
Time frame: Baseline up to 96 weeks
Overall survival (OS)
From the first injection to the time of death from any cause.
Time frame: Baseline up to 96 weeks
Incidence of Anti-Drug antibody
The incidence of anti-drug antibody after administration of TQB2928 injection and penpulimab
Time frame: Cycle 1 day 1, Cycle 5 day 1, and 28 days, 90 days after the last administration. (Each cycle 21 days)
Incidence of neutralizing antibodies
The incidence of neutralizing antibodies after administration of TQB2928 injection and penpulimab
Time frame: Cycle 1 day 1, Cycle 5 day 1, and 28 days, 90 days after the last administration. (Each cycle 21 days)
Peak time (Tmax)
The time to peak concentration
Time frame: Day 1, day 2 , day 4 , day 6 , day 8, day15 of cycle 1 and cycle 2. Each cycle 21 days.
Peak concentration (Cmax)
Maximum plasma drug concentration
Time frame: Day 1, day 2 , day 4 , day 6 , day 8, day15 of cycle 1 and cycle 2. Each cycle 21 days.
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.
Time frame: Day 1, day 2 , day 4 , day 6 , day 8, day15 of cycle 1 and cycle 2. Each cycle 21 days.
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.
Time frame: Day 1, day 2 , day 4 , day 6 , day 8, day15 of cycle 1 and cycle 2. Each cycle 21 days.
Minimum plasma concentration at steady state (Cmin,ss)
The minimum plasma concentration after stabilization
Time frame: Day 1, day 2 , day 4 , day 6 , day 8, day15 of cycle 1 and cycle 2. Each cycle 21 days.
Receptor Occupancy (RO%)
The extent to which antibody drugs occupy cell surface targets
Time frame: 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)

Study locations

5 sites

The Second People's Hospital of Hefei
Hefei, Anhui 230012, China
Lu'an People's Hospital of Anhui Province
Lu'an, Anhui 237008, China
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing 100021, China
Gansu Provincial Cancer Hospital
Lanzhou, Gansu 730000, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong 510000, China

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06297642
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Responsible party: Sponsor
First posted: Mar 7, 2024
Start date: May 24, 2024
Primary completion: Jul 31, 2024
Completion: Jul 31, 2024
Last update: Aug 6, 2024

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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