Clinical trial · Interventional
A Clinical Study to Evaluate the Tolerability and Pharmacokinetics of TQB3617 Capsule in Patients With Advanced Malignant Tumors
Phase I Clinical Study to Evaluate the Tolerability and Pharmacokinetics of TQB3617 Capsule in Patients With Advanced Malignant Tumors
NCT05110807CI-TRIAL-00056509unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
TQB3617 is a bromodomain and extra-terminal (BET) inhibitor that can competitively bind to bromodomains (BRDs) with Acetylated lysine(Kac) and block or partially block the role of KAc in subsequent gene transcription and regulation of chromatin structure, thereby playing an anti-tumor role.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Malignant Tumors | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TQB3617 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TQB3617
- description
- 0.1mg, once daily, was used as the initial dose, and the medication stage was divided into single administration and continuous administration stages. The single administration was given once, and the continuous administration stage was entered 7 days after drug withdrawal. The drug was administered continuously until the disease progressed.
- interventionNames
- Drug: TQB3617
Primary outcomes (2)
- measure
- Maximum tolerated dose (MTD)
- timeFrame
- Baseline up to 48 weeks
- description
- The highest dose of a drug or treatment that does not cause unacceptable side effects.
- measure
- Adverse events (AEs) and serious adverse events (SAEs)
- timeFrame
- Baseline up to 48 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Aged: ≥18 years old. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. * Life expectancy ≥ 3 months. * Patients with advanced malignancy tumor who have failed standard treatment or are unable to receive standard treatment or have no effective treatment. * Female and male subjects should agree to use an adequate method of contraception starting with signing informed consent form (ICF) through 180 days after the last dose of study. The women of reproductive age who blood/urine results were positivetherapy before the first study drug is administered within less than 7 days. Exclusion Criteria: * Patients has had or is currently having other malignant tumors within 3 years. * Patients have multiple factors that affect their oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction). * The patient had unmitigated toxic reactions due to any prior treatment. * Patients underwent major surgical treatment, open biopsy, or significant traumatic injury within 4 weeks prior to the start of study treatment. * Patients have long - term unhealed wounds or fractures. * Patients were taking Cytochrome P450 3A4, Cytochrome P450 3A5, Cytochrome P450 2A6, Cytochrome P450 2D6 (CYP3A4, CYP3A5, CYP2A6,CYP2D6) inhibitors or inducers before oral medication. * Patients who, in the investigator's judgment, have a comorbidity that seriously endangers patient safety or interferes with study completion, or who are considered unsuitable for inclusion for other reasons.
References
Publications (1)
- DERIVEDZhang Y, Yin Q, Zhao B, Liu F, Li S, Cai J, Fang X, Bai B, Nie M, Zou Q, Ding D, Wang X, Zhu J, Yu D, Wang X, Zhang X, Wang L, Xia Y, Cai Q. TQB3617, a bromodomain and extra-terminal inhibitor, in patients with relapsed or refractory lymphoma: A multicenter, phase 1 trial. Med. 2026 Jan 9;7(1):100893. doi: 10.1016/j.medj.2025.100893. Epub 2025 Oct 27. PMID 41151587