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NCT07172126
A Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TQB3201 Tablets in Patients With Advanced Prostate Cancer
Phase 1/Phase 2 trial testing TQB3201 tablets in Metastatic Castration-resistant Prostate Cancer in 291 participants. Not yet recruiting.
1 April 2027
Quick facts
| Lead sponsor | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 291 |
| Start date | 1 September 2025 |
| Primary completion | 1 April 2027 |
| Estimated completion | 1 December 2028 |
| Sites | 3 locations across China |
Drugs / interventions tested
- TQB3201 tablets — full drug profile →
Conditions studied
- Metastatic Castration-resistant Prostate Cancer — all drugs for Metastatic Castration-resistant Prostate Cancer →
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. — full company profile →
Who can join
18 and older, male only, with Metastatic Castration-resistant Prostate 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: Up to 28days
DLTs are defined as toxicities that occur from the first dose to the end of the first treatment cycle by the severity criteria related to the trial drug (according to Common Terminology Criteria for Adverse Events v5.0 toxicity evaluation criteria) . -
Maximum tolerated dose (MTD)
Time frame: Up to 28days
The MTD was defined as the highest dose in ≥ 6 evaluable subjects without any of the following: 1. In the DLT evaluation window, DLT occurred in 2 out of 3 subjects; 2. In the DLT evaluation window, 1 of the first 3 subjects had DLT, and 3 more subjects were added and 1 case had ≥ DLT. -
Phase II Recommended Dose (RP2D)
Time frame: Up to 2 years
The RP2D will be determined based on the safety and tolerability information of the Phase I dose escalation phase and the efficacy and safety information of the Phase II phase. -
Radiographic progression-free survival (rPFS)
Time frame: Up to 2 years
The time from randomization to the first occurrence of either radiologically confirmed disease progression or death from any cause, whichever comes first.
Sponsor's own description
TQB3201 is an orally administered targeted protein chimera (PROTAC) drug in which one end of the drug is attached to a ligand that binds to Androgen Receptor (AR) and the other end to a ligand of E3 ligase (CRBN) via a linker. The phase I phase of this trial aims to evaluate the safety, tolerability, and pharmacokinetic characteristics of TQB3201 tablets for the treatment of advanced prostate cancer.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
E3 Ubiquitin Ligases: Structures, Biological Functions, Diseases, and Therapy.
Wang H, Peng J, Li H, Lan Y, et al · · 2025 · cited 1× · PMID 41362701 · DOI 10.1002/mco2.70528
Verify or expand the search:
- PubMed search for NCT07172126
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Metastatic Castration-resistant Prostate Cancer
Currently open trials in the same condition.
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- NCT07288359 — Study of GVV858 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and · Phase 1, PHASE2 · recruiting
- NCT07244341 — A Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer ( · Phase 1 · recruiting
- NCT07213674 — A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic · Phase 3 · recruiting
- NCT07189403 — A Study of DS9051b in Participants With Advanced or Metastatic Adrenocortical Carcinoma and Metastatic Castration-resist · Phase 1 · recruiting
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 NCT07172126 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- 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: 8 September 2025
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/NCT07172126.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing