A Clinical Study of TQB3823 in Patients With Advanced Malignant Tumor

NCT05021367 | Unknown Phase 1

• 1 other identifier: TQB3823-I-01
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study to evaluate the maximum tolerated dose (MTD) , occurrence of all adverse events (AEs) and serious adverse events (SAEs) , pharmacokinetic parameters and antitumor effect of TQB3823 tablets in Chinese adult patients with advanced solid tumors .The study was divided into phase Ia and phase Ib, Phase Ia: Dose escalation period, to evaluate the safety and tolerability of TQB3823 tablets, determine MTD;Phase Ib: Effectiveness exploration period, to expand the safe and effective dose group, and to recommend appropriate dosage and method for subsequent clinical research.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Dose Limiting Toxicities (DLT)

  Subjects within 28 days after treatment appear the following toxicity reaction relate to the drug ：III °or above of non-hematological toxicity, IV°hematological toxicity ,Neutropenia associated with fever.

  Baseline up to 28 days

• Maximum tolerated dose (MTD)

  The highest dose at which no more than 33% of the subjects experience a dose-limiting toxicity (DLT) during treatment

  Baseline up to 28 days

Secondary Outcomes (14)

• Adverse events (AEs) and serious adverse events (SAEs)

  Baseline up to 28 days

• Overall response rate (ORR)

  21 days

• Disease control rate（DCR）

  21 days

• Progression-free survival (PFS)

  21 days

• Duration of Response (DOR)

  21 days

Study Arms (1)

TQB3823 tablets

EXPERIMENTAL

Subjects receive TQB3823 in the first cycle for a total of 28 days , a single dose on Day 1. Day 2 to Day 7 are the elution period, and the continuous doses are from Day 8 to Day 21. From the second cycle, continuous treatment for 28 days is as a treatment cycle.

Drug: TQB3823 tablets

Interventions

TQB3823 tablets DRUG

TQB3823 is a small molecule Poly ADP-ribose Polymerase (PARP) inhibitor that can inhibit the enzyme activity of PARP1/2, making it difficult to repair the DNA in cancer cells, leading to cell death and delaying or blocking tumor development.

TQB3823 tablets

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who voluntarily join the study, sign the informed consent form, and have good compliance.
• Aged from 18 to 75 years; Eastern Cooperative Oncology Group (ECOG) performance status score: 0-1; at least 3 months expected survival period.
• Subjects with relapse advanced malignant solid tumors clearly diagnosed by pathology and / or cytology, lack of conventional effective treatment methods.
• The function of main organs is normal.
• Subjects need to adopt effective methods of contraception.

You may not qualify if:

• Subjects with other malignancies currently or suffered within 3 years. The following two conditions can be enrolled: other malignant tumors treated with a single operation to achieve disease-free survival (DFS) for 5 consecutive years; cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors\[ Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)\].
• Subjects with multiple factors affecting oral administration.
• Subjets with unhealed toxicity above Grade 1 Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 due to previous antitumor treatment.
• Subjects who have received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before first administration.
• Subjects with long lasting wounds or fractures.
• Subjects with a history of psychotropic drug abuse unable to quit or with mental disorders.
• Subjects with any severe and/or uncontrolled disease.
• Subjects who have received surgery, chemotherapy, radiotherapy or other anticancer therapies 4 weeks before the first administration ( 2 weeks for brain radiotherapy ).
• Subjects who have taken Chinese patent medicines with anti-tumor indications in the drug instructions that National Medical Products Administration (NMPA)approved within 2 weeks before the first administration.
• Subjects with pleural effusion, pericardial effusion or ascites that cannot be controlled and need repeated drainage.
• Subjects with known central nervous system metastases and/or cancerous meningitis.
• Subjects who have participated in other clinical studies within 4 weeks before the first administration.
• According to the judgment of the investigators, there are accompanying diseases that seriously endanger the safety of patients or affect the completion of the study.

Sponsors & Collaborators

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

Study Sites (1)

Sun Yat-sen University Cancer Cen

Guangzhou, Guangdong, 510060, China

Location

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 24, 2021
• First Posted: August 25, 2021
• Study Start: September 23, 2021
• Primary Completion: February 1, 2025
• Study Completion: October 1, 2025
• Last Updated: July 24, 2023

Record last verified: 2023-07

Locations

CN (1)