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A Study of TQB3820 in Patients With Hematological Malignancies

Primary Purpose

Hematological Malignancies

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

TQB3820 tablets

About this trial

This is an interventional treatment trial for Hematological Malignancies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

For Multiple Myeloma cohort
1. Patients must have received at least 2 prior therapies;
2. Measurable levels of myeloma paraprotein
  1. M-protein in serum >5 g/L;
  2. M-protein in urine >200mg/24h;
  3. 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
1. Progressed after standard treatment or no standard treatment with an established survival benefit is available;
2. 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;

Exclusion Criteria:

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.

Sites / Locations

Affiliated Beijing Chaoyang Hospital of Capital Medical UniversityRecruiting
Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TQB3820 tablets

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Maximum Tolerated Dose (MTD)

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

Recommended Phase II Dose (RP2D)

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

Adverse Events (AEs)

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

Secondary Outcome Measures

Maximum (peak) plasma drug concentration (Cmax)

Maximum plasma concentration of drug

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

Time to Maximum plasma concentration of drug

Elimination half-life (t1/2)

Terminal-phase elimination half life

Overall response rate (ORR)

The sum of percentage of participants with stringent complete response rate, complete response rate, very good partial response, partial response rate in MM The sum of percentage of participants with complete response rate, partial response rate for B-NHL

Clinical benefit rate (CBR)

The sum of percentage of participants with stringent complete response rate, complete response rate, very good partial response, partial response rate, minimal response rate in MM

Time to response (TTR)

Time from the first date of dose to the first date of documented response (partial response [PR] or greater).

Duration of Response (DOR)

Time from the first documentation of response (PR or greater) to the first documentation of Progressive disease (PD) or death from any cause, whichever occurs first

Progression-free survival (PFS)

Time from the first dose to the first documentation of PD or death from any cause, whichever occurs first

Overall survival (OS)

Time from the first dose to death due to any cause

Full Information

NCT ID

NCT05020639

First Posted

August 23, 2021

Last Updated

September 18, 2021

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05020639

Brief Title

A Study of TQB3820 in Patients With Hematological Malignancies

Official Title

A Phase I Study to Evaluate the Tolerability and Pharmacokinetics of TQB3820 in Relapsed or Refractory Multiple Myeloma (R/R MM) or Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma (R/R B-NHL)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Recruiting

Study Start Date

August 31, 2021 (Actual)

Primary Completion Date

August 1, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hematological Malignancies

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

116 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TQB3820 tablets

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

TQB3820 tablets

Intervention Description

TQB3820 is a novel cereblon-modulating agent.

Primary Outcome Measure Information:

Title

Dose-limiting toxicity (DLT)

Description

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.

Time Frame

up to 18 months

Title

Maximum Tolerated Dose (MTD)

Description

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

Time Frame

up to 18 months

Title

Recommended Phase II Dose (RP2D)

Description

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

Time Frame

up to 18 months

Title

Adverse Events (AEs)

Description

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

Time Frame

Baseline up to 24 months

Secondary Outcome Measure Information:

Title

Maximum (peak) plasma drug concentration (Cmax)

Description

Maximum plasma concentration of drug

Time Frame

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)

Title

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

Description

Time to Maximum plasma concentration of drug

Time Frame

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)

Title

Elimination half-life (t1/2)

Description

Terminal-phase elimination half life

Time Frame

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)

Title

Overall response rate (ORR)

Description

Time Frame

Baseline up to 24 months

Title

Clinical benefit rate (CBR)

Description

The sum of percentage of participants with stringent complete response rate, complete response rate, very good partial response, partial response rate, minimal response rate in MM

Time Frame

Baseline up to 24 months

Title

Time to response (TTR)

Description

Time from the first date of dose to the first date of documented response (partial response [PR] or greater).

Time Frame

Baseline up to 24 months

Title

Duration of Response (DOR)

Description

Time from the first documentation of response (PR or greater) to the first documentation of Progressive disease (PD) or death from any cause, whichever occurs first

Time Frame

Baseline up to 24 months

Title

Progression-free survival (PFS)

Description

Time from the first dose to the first documentation of PD or death from any cause, whichever occurs first

Time Frame

Baseline up to 24 months

Title

Overall survival (OS)

Description

Time from the first dose to death due to any cause

Time Frame

Baseline up to 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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; Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lugui Qiu, Doctor

Phone

022-23909172

qiulg@ihcams.ac.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Junyuan Qi, Doctor

Phone

022-23909067

qijy@ihcams.ac.cn

Facility Information:

Facility Name

Affiliated Beijing Chaoyang Hospital of Capital Medical University

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100020

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wenming Chen, Doctor

Phone

13910107759

13910107759@163.com

Facility Name

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

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

30020

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lugui Qiu, Doctor

Phone

022-23909172

qiulg@ihcams.ac.cn

First Name & Middle Initial & Last Name & Degree

Junyuan Qi, Doctor

Phone

022-23909067

qijy@ihcms.ac.cn

12. IPD Sharing Statement

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A Study of TQB3820 in Patients With Hematological Malignancies

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