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NCT06415903
A Phase I Study to Evaluate the Safety and Tolerance of TQB3117 Tablets in Patients With Advanced Malignant Cancer
Phase 1 trial testing TQB3117 tablets in Advanced Malignant Cancer in 59 participants. Not yet recruiting.
1 June 2025
Quick facts
| Lead sponsor | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 59 |
| Start date | 1 June 2024 |
| Primary completion | 1 June 2025 |
| Estimated completion | 1 August 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- TQB3117 tablets — full drug profile →
Conditions studied
- Advanced Malignant Cancer — all drugs for Advanced Malignant Cancer →
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. — full company profile →
Who can join
Adults 18 to 75, any sex, with Advanced Malignant Cancer. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Dose Limiting Toxicity (DLT)
Time frame: At the end of Cycle 1 (each cycle is 21 days)
DLT refers to occurrence of drug-related adverse events within the first treatment cycle after subjects receive single-dose or multiple-dose treatment, as defined by the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 toxicity assessment criteria. -
Maximum tolerated dose (MTD)
Time frame: At the end of Cycle 1 (each cycle is 21 days)
MTD is defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients. -
Recommended Phase II Dose (RP2D)
Time frame: Baseline up to 24 months
DLT describes side effects of a drug or other treatment that are serious enough to evaluate RP2D of TQB3117 tablets in adult patients with advanced malignant cancer.
Sponsor's own description
The study is divided into two phases: dose escalation and dose extension. The dosing regimens include a single-dose study and a multiple-dose study. It adopts a single-center, open-label, non-randomized, single-arm clinical trial design, where patients with advanced malignant cancer are selected to orally take TQB3117 tablets. The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of TQB3117 tablets in patients.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06415903
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Chia Tai Tianqing Pharmaceutical Group Co., Ltd. trials
Trials by the same sponsor.
- NCT06990776 — A Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets in Treatment-naive Chronic HBV-infected Subjects · Phase 2 · withdrawn
- NCT06851442 — Clinical Trial of Evaluating TQB3912 Tablets Combined With Fulvestrant Injection±TQB3616 Capsules for Locally Advanced o · Phase 1, PHASE2 · terminated
- NCT06711991 — A Clinical Trial of TQC3927 Powder for Inhalation in Chronic Obstructive Pulmonary Disease · Phase 1 · completed
- NCT06672276 — To Evaluate the Pharmacokinetics and Safety of TQD3606 for Injection in Subjects With Renal Insufficiency · Phase 1 · completed
- NCT06644417 — Clinical Study of TQA3605 Tablets Combined With Nucleoside (Acid) Analogs (NAs) Drugs Compared With NAs Drugs in the Tre · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06415903 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Last refreshed: 14 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06415903.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing