A Study of TQB3820 in Patients With Hematological Malignancies

NCT05020639 | Unknown Phase 1

• 1 other identifier: TQB3820-I-01
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 2

Brief Summary

TQB3820 is a novel cereblon-modulating agent. Upon binding to cereblon, a substrate receptor in the cullin4 E3 ligase complex, TQB3820 promotes recruitment, ubiquitination, and subsequent proteasomal degradation of the hematopoietic transcription factors Ikaros (IKZF1) and Aiolos (IKZF3). Modulation of Aiolos and Ikaros expression has the potential to correct multiple aspects of the immune dysregulation mediated by B cells.

Conditions

Hematological Malignancies

Outcome Measures

Primary Outcomes (4)

• Dose-limiting toxicity (DLT)

  DLT describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.

  up to 18 months

• Maximum Tolerated Dose (MTD)

  The maximum Dose at which less than 33% subjects experiencing DLT

  up to 18 months

• Recommended Phase II Dose (RP2D)

  RP2D will be based on evaluation of clinical safety and tolerability and guided by accumulating pharmacokinetics (PK) data

  up to 18 months

• Adverse Events (AEs)

  Type, frequency, seriousness and severity of adverse events and laboratory abnormalities, such as hyperuricemia.

  Baseline up to 24 months

Secondary Outcomes (9)

• Maximum (peak) plasma drug concentration (Cmax)

  Hour 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on single dose ; Hour 0(pre-dose) of day1, day8, day15, day22 on multiple dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on multiple dose of day28)

• Time to reach maximum(peak )plasma concentration following drug administration (Tmax)

  Hour 0(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on single dose ; Hour 0(pre-dose) of day1, day8, day15, day22 on multiple dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on multiple dose of day28)

• Elimination half-life (t1/2)

  Hour 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on single dose ; Hour 0 (pre-dose) of day1, day8, day15, day22 on multiple dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on multiple dose of day28)

• Overall response rate (ORR)

  Baseline up to 24 months

• Clinical benefit rate (CBR)

  Baseline up to 24 months

Study Arms (1)

TQB3820 tablets

EXPERIMENTAL

TQB3820 tablets are administrated orally on Days 1-28 of each 28-day treatment cycle. Dose escalation of TQB3820 will be based on evaluation of clinical safety and tolerability and guided by accumulating PK data.

Drug: TQB3820 tablets

Interventions

TQB3820 tablets DRUG

TQB3820 is a novel cereblon-modulating agent.

TQB3820 tablets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For Multiple Myeloma cohort
• Patients must have received at least 2 prior therapies;
• Measurable levels of myeloma paraprotein
• M-protein in serum \>5 g/L;
• M-protein in urine \>200mg/24h;
• Light chain Multiple Myeloma without measurable disease in the serum or urine: serum immunoglobulin free light chain ≥ 100 mg/L and abnormal serum immunoglobulin kappa lambda free light chain ratio.
• For Indolent B-NHL
• Progressed after standard treatment or no standard treatment with an established survival benefit is available;
• Imaging in screening showing at least one measurable lesion; In patients with CLL/SLL, circulating lymphocytes \>= 5.0 × 10\^9/L or lesions greater than 1.5 cm.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;
• Life expectancy \>=3 months;
• Adequate organ/system function;
• Female patients of childbearing age should agree to use contraceptive measures during the study period and for at least 6 months after study is stopped; male patients should agree to use contraception during the study period and for at least 6 months after study is stopped;

You may not qualify if:

• Patients received allogenic haemopoietic stem cell transplantation, or autologous stem cell transplantation within 3 months;
• Diagnosed and/or treated additional malignancy within 3 years before the first dose;
• With factors affecting oral medication;
• Toxicity that is \>=Grade 2 caused by previous cancer therapy;
• Patients with congenital bleeding or coagulopathy, or are being treated with anticoagulants;
• Patients with uncontrolled infections;
• Has received surgery, chemotherapy, radiotherapy or other anticancer therapies 2 weeks before the first dose;
• Has received Chinese patent medicines with anti-tumor indications that National Medical Products Administration(NMPA) approved within 2 weeks before the first dose;
• Pleural effusion, pericardial effusion or ascites that cannot be controlled and need repeated drainage;
• Central nervous system metastases;
• Has participated in other clinical studies within 4 weeks before the first dose;
• According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (2)

Affiliated Beijing Chaoyang Hospital of Capital Medical University

Beijing, Beijing Municipality, 100020, China

RECRUITING

Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Tianjin, Tianjin Municipality, 30020, China

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Lugui Qiu, Doctor

CONTACT

022-23909172; qiulg@ihcams.ac.cn

Junyuan Qi, Doctor

CONTACT

022-23909067; qijy@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: August 25, 2021
• Study Start: August 31, 2021
• Primary Completion: August 1, 2024
• Study Completion: December 31, 2024
• Last Updated: September 21, 2021

Record last verified: 2021-09

Locations

CN (2)