Clinical trial NCT06297642: TQB2928 Injection Combined With Penpulimab in Treatment of Advanced Malignant Tumors.
Official title: A Phase Ib Clinical Trial of TQB2928 Injection Combined With Penpulimab in the Treatment of Patients With Advanced Malignant Tumors.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Advanced Malignant Neoplasm
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-03-07
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: Dose limiting toxicity (DLT)
timeFrame: Baseline up to 3 weeks
measure: Adverse event rate
timeFrame: Baseline up to 96 weeks
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: Baseline up to 96 weeks
measure: Complete response rate (CRR)
timeFrame: Baseline up to 96 weeks
measure: Disease Control Rate
timeFrame: Baseline up to 96 weeks
measure: Duration of Response
timeFrame: Baseline up to 96 weeks
measure: Progression-free Survival
timeFrame: Baseline up to 96 weeks
measure: Overall survival (OS)
timeFrame: Baseline up to 96 weeks
measure: Incidence of Anti-Drug antibody
timeFrame: Cycle 1 day 1, Cycle 5 day 1, and 28 days, 90 days after the last administration. (Each cycle 21 days)
measure: Incidence of neutralizing antibodies
timeFrame: Cycle 1 day 1, Cycle 5 day 1, and 28 days, 90 days after the last administration. (Each cycle 21 days)
measure: Peak time (Tmax)
timeFrame: Day 1, day 2 , day 4 , day 6 , day 8, day15 of cycle 1 and cycle 2. Each cycle 21 days.
measure: Peak concentration (Cmax)
timeFrame: Day 1, day 2 , day 4 , day 6 , day 8, day15 of cycle 1 and cycle 2. Each cycle 21 days.
measure: The area under the plasma concentration time curve from zero to after 24h (AUC0-24h)
timeFrame: Day 1, day 2 , day 4 , day 6 , day 8, day15 of cycle 1 and cycle 2. Each cycle 21 days.
measure: Steady-state apparent volume of distribution (Vz/F)
timeFrame: Day 1, day 2 , day 4 , day 6 , day 8, day15 of cycle 1 and cycle 2. Each cycle 21 days.
measure: Minimum plasma concentration at steady state (Cmin,ss)
timeFrame: Day 1, day 2 , day 4 , day 6 , day 8, day15 of cycle 1 and cycle 2. Each cycle 21 days.
measure: Receptor Occupancy (RO%)
timeFrame: 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)
Other outcomes:
Locations:
city: Hefei
country: China
facility: The Second People's Hospital of Hefei
state: Anhui
city: Lu'an
country: China
facility: Lu'an People's Hospital of Anhui Province
state: Anhui
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Science
state: Beijing
city: Lanzhou
country: China
facility: Gansu Provincial Cancer Hospital
state: Gansu
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References: