NCT05117658

A Single-Arm, Multi-Centre, Open-Label Phase II Study of HA121-28 in Patients With RET Fusion-Positive Advanced Non-Small Cell Lung Cancer

Status unknown Phase 2 Last updated 2 August 2022

What this trial tests

Phase 2 trial testing HA121-28 tablet in NSCLC in 83 participants. Status unknown.

Timeline

18 February 2022

Primary endpoint
1 October 2023

1 October 2023

Quick facts

Lead sponsor	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	83
Start date	18 February 2022
Primary completion	1 October 2023
Estimated completion	1 October 2023
Sites	1 location across China

Drugs / interventions tested

• HA121-28 tablet — full drug profile →

Conditions studied

• NSCLC — all drugs for NSCLC →

Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd. — full company profile →

Who can join

Adults 18 to 75, any sex, with NSCLC. 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.

• Objective Response Rate (ORR)
  Time frame: Up to approximately 12 months
  The percentage of patients who achieve a complete response (CR) or partial response (PR) evaluated by Independent Review Committee (IRC) according to RECIST 1.1.

Sponsor's own description

This study is a multicenter, open-label, single-arm phase II study to evaluate efficacy and safety of HA121-28 tablets in patients with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC).

Publications & conference data

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

1. New Generations of Tyrosine Kinase Inhibitors in Treating NSCLC with Oncogene Addiction: Strengths and Limitations.
   Attili I, Corvaja C, Spitaleri G, Del Signore E, et al · · 2023 · cited 32× · PMID 37894445 · DOI 10.3390/cancers15205079
2. 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
3. Selective RET Inhibitors (SRIs) in Cancer: A Journey from Multi-Kinase Inhibitors to the Next Generation of SRIs.
   Clark L, Fisher G, Brook S, Patel S, et al · · 2023 · cited 6× · PMID 38201460 · DOI 10.3390/cancers16010031
4. Non-Small-Cell Lung Cancers (NSCLCs) Harboring RET Gene Fusion, from Their Discovery to the Advent of New Selective Potent RET Inhibitors: "Shadows and Fogs".
   Spitaleri G, Trillo Aliaga P, Attili I, Del Signore E, et al · · 2024 · cited 4× · PMID 39199650 · DOI 10.3390/cancers16162877
5. Treatment of non-small cell lung cancer with RET rearrangements.
   Hoe HJ, Solomon BJ. · · 2025 · cited 3× · PMID 40171987 · DOI 10.1002/cncr.35779
6. Safety, pharmacokinetics and efficacy of HA121-28 in patients with advanced solid tumors and RET fusion-positive non-small-cell lung cancer: a multicenter, open-label, single-arm phase 1/2 trial.
   Ruan DY, Huang WW, Li Y, Zhao Y, et al · · 2025 · PMID 40016191 · DOI 10.1038/s41392-025-02155-5
7. Effects of Food on the Pharmacokinetics and Safety of HA121-28 Tablet, a Novel Multi-Targeting Tyrosine Kinase Inhibitor, in Healthy Chinese Subjects: A Phase I Clinical Trial.
   Liu Y, Li X, Zhang M, Men Y, et al · · 2025 · PMID 39876990 · DOI 10.2147/dddt.s484310