Who is sponsoring NCT04996121?

NCT04996121 is sponsored by Xuanzhu Biopharmaceutical Co., Ltd..

What drugs are being tested in NCT04996121?

Interventions in NCT04996121: XZP-5955 tablets.

What condition does NCT04996121 study?

NCT04996121 studies Locally Advanced or Metastatic Solid Tumors, Locally Advanced or Metastatic Non-small Cell Lung Cancer.

Is NCT04996121 still recruiting?

NCT04996121 is currently recruiting now. Last updated 28 August 2022.

Last reviewed 2022-08-28 · How we verify

NCT04996121

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Safety Tolerability Pharmacokinetic Characteristics and Efficacy of XZP-5955 Tablets in Patients With NTRK or ROS1 Gene Fusion Locally Advanced or Metastatic Solid Tumors in a Single-arm Open-label Multi-center Phase I/II Clinical Study

Recruiting now Phase 1/Phase 2 Last updated 28 August 2022

What this trial tests

Phase 1/Phase 2 trial testing XZP-5955 tablets in Locally Advanced or Metastatic Solid Tumors in 360 participants. Currently enrolling.

Timeline

6 December 2021

Primary endpoint
1 September 2025

1 June 2027

Quick facts

Lead sponsor	Xuanzhu Biopharmaceutical Co., Ltd.
Phase	Phase 1/Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	360
Start date	6 December 2021
Primary completion	1 September 2025
Estimated completion	1 June 2027
Sites	1 location across China

Drugs / interventions tested

XZP-5955 tablets — full drug profile →

Conditions studied

Locally Advanced or Metastatic Solid Tumors — all drugs for Locally Advanced or Metastatic Solid Tumors →
Locally Advanced or Metastatic Non-small Cell Lung Cancer — all drugs for Locally Advanced or Metastatic Non-small Cell Lung Cancer →

Sponsor

Xuanzhu Biopharmaceutical Co., Ltd. — full company profile →

Who can join

18 and older, any sex, with Locally Advanced or Metastatic Solid Tumors or Locally Advanced or Metastatic Non-small Cell Lung 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.

Maximum tolerated dose (MTD) (Phase I dose escalation)
Time frame: 24days following first dose of XZP-5955
Determine MTD of XZP-5955
Number of patients with adverse events (Phase I dose escalation)
Time frame: within 30 days from last dose
Incidence of AE as assessed by CTCAE 5.0
Overall Response Rate (ORR) by Blinded Independent Central Review (BICR) (Phase I dose expansion and phase II)
Time frame: 2 to 3 years after first dose of XZP-5955
Per RECIST v1.1 as assessed by BICR

Sponsor's own description

A phase I/II study to examine the safety, tolerability, pharmacokinetics and efficacy of XZP-5955 tablets in patients with advanced solid tumors harboring NTRK or ROS1 gene fusion

Publications & conference data

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

NTRK Fusion in Non-Small Cell Lung Cancer: Diagnosis, Therapy, and TRK Inhibitor Resistance.
Liu F, Wei Y, Zhang H, Jiang J, et al · · 2022 · cited 61× · PMID 35372074 · DOI 10.3389/fonc.2022.864666
Clinically relevant fusion oncogenes: detection and practical implications.
Sorokin M, Rabushko E, Rozenberg JM, Mohammad T, et al · · 2022 · cited 25× · PMID 36601633 · DOI 10.1177/17588359221144108
Targeted therapies in non-small cell lung cancer: present and future.
McLaughlin J, Berkman J, Nana-Sinkam P. · · 2023 · cited 11× · PMID 37675274 · DOI 10.12703/r/12-22
Tissue-Agnostic Targeting of Neurotrophic Tyrosine Receptor Kinase Fusions: Current Approvals and Future Directions.
Gouda MA, Thein KZ, Hong DS. · · 2024 · cited 5× · PMID 39410015 · DOI 10.3390/cancers16193395

Verify or expand the search:

Other recruiting trials for Locally Advanced or Metastatic Solid Tumors

Currently open trials in the same condition.

NCT07202364 — A Study of YL202 in Patients With Advanced Solid Tumors · Phase 2 · recruiting
NCT06418061 — Study of IBI3005 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors · Phase 1 · recruiting
NCT07461181 — A Study to Evaluate the Safety, Tolerability, PK, PD, and Preliminary Efficacy of CS01 in Patients With Locally Advanced · Phase 1, PHASE2 · active not recruiting
NCT06545331 — Study of XB010 in Subjects With Solid Tumors · Phase 1 · recruiting
NCT06328439 — A Study to Evaluate ANS014004 in Subjects With Locally Advanced or Metastatic Solid Tumors · Phase 1 · active not recruiting

Other Xuanzhu Biopharmaceutical Co., Ltd. trials

Trials by the same sponsor.

NCT07345689 — A Study of the Pharmacokinetics and Safety of Anaprazole Sodium in Special Populations · Phase 4 · not yet recruiting
NCT07330531 — Drug-drug Interaction Study of Rifampin and Anaprazole Sodium · Phase 4 · not yet recruiting
NCT05586568 — Drug-drug Interaction Study of XZP-3621 Tablet · Phase 1 · unknown
NCT05478109 — A Clinical Trial of XZP-3287 for Material Balance · Phase 1 · unknown
NCT05257395 — A Study of XZP-3287 in Combination With Letrozole/Anastrozole in Patients With Advanced Breast Cancer · Phase 3 · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04996121 (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 Xuanzhu Biopharmaceutical Co., Ltd.
Last refreshed: 28 August 2022

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/NCT04996121.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing