NCT05107037

A Phase I Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of TQ-B3234 Capsules in Chinese Patients With Type I Neurofibromatosis (Neurofibromatosis and Malignant Peripheral Nerve Sheath Tumors)

Status unknown Phase 1 Last updated 22 October 2021

What this trial tests

Phase 1 trial testing TQ-B3234 capsule in Type I Neurofibromatosis in 120 participants. Status unknown.

Timeline

1 November 2021

Primary endpoint
1 December 2023

1 December 2024

Quick facts

Lead sponsor	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	120
Start date	1 November 2021
Primary completion	1 December 2023
Estimated completion	1 December 2024
Sites	1 location across China

Drugs / interventions tested

• TQ-B3234 capsule

Conditions studied

• Type I Neurofibromatosis — all drugs for Type I Neurofibromatosis →

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd. — full company profile →

Who can join

Adults 18 to 75, any sex, with Type I Neurofibromatosis. 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.

• Maximum tolerated dose (MTD)
  Time frame: Baseline up to 48weeks
  If DLT occurs in 2 or more subjects in a given dose group, the dose level in the previous dose group is considered MTD
• Dose limiting toxicity (DLT)
  Time frame: Baseline up to 4 weeks
  Some drug-related toxicities occurred within 28 days of treatment
• Phase II clinical recommended dose （RP2D）
  Time frame: Baseline up to 48 weeks
  Phase II clinical recommended dose
• objective response rate（ORR）
  Time frame: Baseline up to 96 weeks
  Percentage of participants achieving complete response (CR) and partial response (PR).

Sponsor's own description

This study is a Phase I clinical trial to evaluate the tolerability and pharmacokinetics of TQ-B3234 capsules in Chinese subjects associated with neurofibromatosis type I (neurofibroma and peripheral malignant neurilemmoma).

Two study phases were designed, including (1) dose escalation and (2) cohort expansion.

The purpose of this study was to evaluate the tolerance, pharmacokinetic characteristics, efficacy and safety of TQ-B3234 capsule, and to explore the therapeutic biomarkers related to this product.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Diagnosis and Treatment of Peripheral and Cranial Nerve Tumors with Expert Recommendations: An EUropean Network for RAre CANcers (EURACAN) Initiative.
   Pellerino A, Verdijk RM, Nichelli L, Andratschke NH, et al · · 2023 · cited 20× · PMID 37046591 · DOI 10.3390/cancers15071930
2. A Sequencing Overview of Malignant Peripheral Nerve Sheath Tumors: Findings and Implications for Treatment.
   Xiao K, Yang K, Hirbe AC. · · 2025 · cited 5× · PMID 39857962 · DOI 10.3390/cancers17020180
3. Current state of spinal nerve sheath tumor management and future advances.
   Gui C, Canthiya L, Zadeh G, Suppiah S. · · 2024 · cited 5× · PMID 39430389 · DOI 10.1093/noajnl/vdae067
4. The Contribution of Oxidative Stress to <i>NF1</i>-Altered Tumors.
   Kuhn E, Natacci F, Corbo M, Pisani L, et al · · 2023 · cited 4× · PMID 37627552 · DOI 10.3390/antiox12081557
5. Rare primary intrapulmonary malignant peripheral nerve sheath tumor showing significant response to sintilimab: A case report and literature review.
   Chen Y, Chen T, Zhu W, Li L, et al · · 2024 · cited 3× · PMID 39035047 · DOI 10.3892/ol.2024.14556
6. Trametinib and Fimepinostat Induce Malignant Peripheral Nerve Sheath Tumor Cell Death In Vitro
   · 2026