A Clinical Study of TQB3912 Tablets in Patients With Advanced Malignant Tumor

Launched by CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD. · Aug 10, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called TQB3912, which comes in tablet form, for patients with advanced malignant tumors, commonly known as cancer. The main goals of the study are to find out the highest dose of the medication that patients can safely tolerate, track any side effects, and see how well the medication works in fighting the cancer. The trial is organized into two parts: the first part focuses on safety and determining the right dose, while the second part looks at how effective the medication is at that dose.

To be eligible for this trial, participants need to be between 18 and 75 years old and have advanced solid tumors that have been diagnosed by a doctor. They should also be in generally good health with normal organ function and have a reasonable expectation of survival. However, there are some conditions that would exclude someone from participating, such as having other active cancers, severe health issues, or recent major surgeries. It's important to know that this trial is not yet recruiting participants, so it may take some time before anyone can join.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 performance status score: 0-2; at least 3 months of expected survival period.
• • Subjects with relapse advanced malignant solid tumors clearly diagnosed by pathology and/or cytology.
• • The function of main organs is normal.
• • Subjects need to adopt effective methods of contraception.
• Exclusion Criteria:
• • Subjects with other malignancies currently or suffered within 3 years.
• • Subjects with Grade 1 or above unhealed toxicity reaction of Common Terminology Criteria for Adverse Events 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.
• • Subjects who have taken Chinese patent medicines with anti-tumor indications in the drug instructions that National Medical Products Administration 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 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.