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NCT07407803
Randomized, Double-Blind, Parallel-Controlled, Multicenter Phase III Clinical Trial Evaluating the Efficacy and Safety of TQ-B3234 Capsules Versus Placebo in Patients With Symptomatic, Non-Surgical Type 1 Neurofibromatosis-Associated Plexiform Neurofibromas
Phase 3 trial testing TQ-B3234 capsules in Plexiform Neurofibroma in 177 participants. Currently enrolling.
1 December 2027
Quick facts
| Lead sponsor | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 177 |
| Start date | 31 March 2026 |
| Primary completion | 1 December 2027 |
| Estimated completion | 1 December 2028 |
| Sites | 29 locations across China |
Drugs / interventions tested
- TQ-B3234 capsules — full drug profile →
- TQ-B3234 placebo — full drug profile →
Conditions studied
- Plexiform Neurofibroma — all drugs for Plexiform Neurofibroma →
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. — full company profile →
Who can join
18 and older, any sex, with Plexiform Neurofibroma. 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.
-
IRC-Assessed Objective Response Rate (ORR)
Time frame: From subject enrollment to the end of cycle 24 (each cycle is 28 days)
Percentage of subjects achieving complete response (CR) or partial response (PR) as assessed by independent review committee (IRC) per REiNS criteria at the end of Cycle 24.
Sponsor's own description
This study aims to demonstrate that in subjects with symptomatic, inoperable plexiform neurofibromas associated with neurofibromatosis type 1, TQ-B3234 capsules significantly improve the objective response rate at Week 24 compared to placebo.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07407803
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Plexiform Neurofibroma
Currently open trials in the same condition.
- NCT06188741 — Selumetinib for the Prevention of Plexiform Neurofibroma Growth in NF Type 1 · Phase 2 · recruiting
- NCT06104488 — A Study of Avutometinib for People With Solid Tumor Cancers · Phase 1 · recruiting
- NCT05913037 — FCN-159 in Adult Patients With Symptomatic, Inoperable Neurofibromatosis Type 1-Related Plexiform Neurofibromas · Phase 3 · active not recruiting
- NCT04954001 — Study to Evaluate the Safety, Tolerability, PK Characteristics and Anti-tumor Activity of FCN-159 in Adult and Pediatric · Phase 1, PHASE2 · active not recruiting
- NCT03962543 — MEK Inhibitor Mirdametinib (PD-0325901) in Patients With Neurofibromatosis Type 1 Associated Plexiform Neurofibromas · Phase 2 · active not 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 NCT07407803 (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: 22 May 2026
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/NCT07407803.
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