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

NCT ID: NCT06211751

Last Updated: 2024-01-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2026-06-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TQB3909 tablets+ TQB3702 tablets

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

Group Type: EXPERIMENTAL

TQB3909 tablets

Intervention Type: DRUG

TQB3909 is a protein inhibitor.

TQB3702 tablets

Intervention Type: DRUG

TQB3702 is a kinase inhibitor.

Interventions

TQB3909 tablets

TQB3909 is a protein inhibitor.

Intervention Type: DRUG

TQB3702 tablets

TQB3702 is a kinase inhibitor.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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:

1. Dose escalation stage: non-Hodgkin's B-cell lymphoma;

2. 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.

Exclusion Criteria

• 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;
• Study treatment related: subjects received live or mRNA vaccines within 4 weeks before the first treatment or were scheduled to receive live or mRNA vaccines during the study;
• Participated in clinical trials of other antitumor drugs within 4 weeks before the first dose;
• According to the investigator's judgment, there are concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects who are considered unsuitable for enrollment for other reasons

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Henan Cancer Hospital

Zhengzhou, Henan, China

Countries

China

Central Contacts

Yanyan Liu, Doctor

Role: CONTACT

yyliu@zzu.edu.cn

+86-13838176375

Facility Contacts

Yanyan Liu, Doctor

Role: primary

yyliu@zzu.edu.cn

+86-13838176375

Other Identifiers

TQB3909-TQB3702-Ib -01

Identifier Type: -

Identifier Source: org_study_id