A Clinical Trial of TQB3909 Tablets Combined With TQB3702 Tablets in Patients With Hematologic Malignancy

NCT06211751 | Not Yet Recruiting Phase 1

• 1 other identifier: TQB3909-TQB3702-Ib -01
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open, multi-cohort clinical study. The first phase is a dose escalation study and the second phase is a dose expansion study based on the Maximum tolerated dose (MTD) / Recommended Phase II Dose (RP2D) obtained in the first phase. The purpose is to evaluate the safety and preliminary efficacy of TQB3909 tablets combined with TQB3702 tablets in hematologic malignancy subjects.

Conditions

Hematologic Malignancy

Outcome Measures

Primary Outcomes (4)

• Dose limited toxicity (DLT)

  DLT will be defined as toxicities that meet pre-defined severity criteria (according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0), and assessed as having a suspected relationship to study drug.

  Baseline up to 104 weeks

• Adverse events (AE)

  The occurrence of all adverse events (AE).

  Baseline up to 104 weeks

• Serious adverse events (SAE)

  The occurrence of all serious adverse events (SAE).

  Baseline up to 104 weeks

• Clinical laboratory abnormalities

  Incidence of participants with abnormal clinical laboratory test results.

  Baseline up to 104 weeks

Secondary Outcomes (14)

• Complete remission rate (CRR)/ Complete remission with incomplete bone marrow recovery rate (CRi)

  Baseline up to 104 weeks

• Objective Response Rate (ORR)

  Baseline up to 104 weeks

• Undetectable measurable residual disease (U-MRD) ratio of peripheral blood and/or bone marrow

  Baseline up to 104 weeks

• Duration of complete remission / complete remission with incomplete bone marrow recovery

  Baseline up to 104 weeks

• Duration of Response (DOR)

  Baseline up to 104 weeks

Study Arms (1)

TQB3909 tablets+ TQB3702 tablets

EXPERIMENTAL

TQB3909 tablets combined with TQB3702 tablets, administered orally, 28 days as a treatment cycle.

Drug: TQB3909 tablets; Drug: TQB3702 tablets

Interventions

TQB3909 tablets DRUG

TQB3909 is a protein inhibitor.

TQB3909 tablets+ TQB3702 tablets

TQB3702 tablets DRUG

TQB3702 is a kinase inhibitor.

TQB3909 tablets+ TQB3702 tablets

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects voluntarily joined the study, signed informed consent form, and with good compliance.
• ≥ 18 years old, ≤75 years old (when signing informed consent form); Eastern Cooperative Oncology Group (ECOG) physical status: 0-2; at least 3 months expected survival period.
• Subject population:
• Dose escalation stage: non-Hodgkin's B-cell lymphoma;
• Dose expansion stage: non-Hodgkin's lymphoma, etc.
• At least 1 lesion / measurable disease for efficacy evaluation.
• The function of main organs is normal.
• Female patients of childbearing age should agree to use contraceptive measures during the study period and for at least 6 months after the completion of the study; a negative serum pregnancy test within 7 days prior to study enrollment and must be non-lactating subjects; male patients should agree to use contraception during the study period and for at least 6 months after the completion of the study.

You may not qualify if:

• Patients has occured or is currently having other malignant tumors within 5 years. The following two conditions can be included: other malignant tumors treated with a single operation to achieved 5 consecutive years of disease free survival (DFS). Cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basal membrane)\] and papillary thyroid carcinoma.
• Burkitt lymphoma, lymphoblastic lymphoma/leukemia, etc.
• For cohort A and cohort B: Richter transformation occured.
• Subjects with central nervous system (CNS) aggression;
• Previously received allogeneic hematopoietic stem cell transplantation;
• For Cohort B/D/E: Received autologous hematopoietic stem cell transplantation within 3 months before the first dose;
• Multiple factors that affect the absorption of oral medications (e.g., inability to swallow, chronic diarrhea, and intestinal obstruction);
• Unrelieved toxicity of ≥CTCAE grade 1 due to any previous treatment, excluding alopecia and fatigue;
• Major surgical treatment, open biopsy, and significant traumatic injury received within 28 days before the start of study treatment.
• Having active or uncontrolled primary autoimmune hemocytopenia, including autoimmune hemolytic anemia (AIHA), primary immune thrombocytopenia (ITP), etc.
• Patients with evidence or history of bleeding constitution; Or any bleeding event (such as gastrointestinal bleeding) greater than or equal to CTCAE level 3 within 4 weeks before the first dose;
• Subjects who had an arteriovenous thrombosis event within 6 months.
• Subjects who had a history of psychotropic substance abuse and are unable to abstain or have mental disorders;
• Subjects with any severe and/or uncontrolled disease.
• Within one weeks before the first dose, the subjects had received proprietary Chinese medicines with anti-tumor indications specified in the National Medical Products Administration (NMPA) approved drug instructions;

Sponsors & Collaborators

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

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Yanyan Liu, Doctor

CONTACT

+86-13838176375; yyliu@zzu.edu.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: January 9, 2024
• First Posted: January 18, 2024
• Study Start: January 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 18, 2024

Record last verified: 2024-01

Locations

CN (1)