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NSCLCPhase 2NCT05117658

Study of HA121-28 in Patients With Non-Small Cell Lung Cancer

A Phase 2 study testing HA121-28 tablet in people with NSCLC, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
NSCLC
What is being tested?
HA121-28 tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
83 participants
Where
1 siteChina
Study dates
18 Feb 2022to Oct 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily participate in this study and sign the informed consent form;
  • Aged 18 ~ 75 years old (inclusive), male or female;
  • Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic non-small cell lung cancer;
  • RET gene fusion, as demonstrated by "Next-generation" sequencing(NGS) method in central laboratory with College of American Pathologists(CAP) or Clinical Laboratory Improvement Amendments(CLIA) certification;
  • Progressive disease after at least one line of standard therapy (including patients with disease progression during or within 6 months of the end of adjuvant therapy);
  • At least one measurable lesion according to RECIST 1.1 (for lesions previously treated with radiation, the lesion can be included as a measurable lesion only if there is clear disease progression after radiotherapy);
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  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-1;
  • Adequate organ function, laboratory tests meeting the following criteria:
  • Neutrophil count (ANC) ≥ 1.5 × 10^9/L (no G-CSF for WBC-elevating therapy within 2 weeks prior to the laboratory test);
  • Platelet count (PLT) ≥ 75 × 10^9/L (no platelet transfusion or other drugs to promote platelet production within 2 weeks prior to the laboratory test);
  • Hemoglobin (Hb) ≥ 90 g/L; (not receiving red blood cell transfusion or erythropoiesis-stimulating drugs within 2 weeks prior to the laboratory test);
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN) (≤ 5.0 × ULN for patients with liver metastases);
  • Serum total bilirubin (TBIL) ≤ 1.5 × ULN;
  • Serum creatinine ≤ 1.5 × ULN;
  • Albumin ≥ 30 g/L;
  • Male and female patients of childbearing age agree to take effective contraceptive measures during treatment and within 6 months after the completion of treatment.

Who cannot join

  • Had a documented oncogenic driver gene alteration other than RET in NSCLC, ie, activating EGFR, BRAF, or KRAS mutation, MET exon 14 skipping mutation or high-level amplification, and ALK, ROS1, or NTRK1/2/3 gene fusions;
  • Prior treatment with selective RET inhibitors (including investigational selective RET inhibitors, such as LOXO-292, BLU-667, RXDX-105, etc.);
  • Patients who previously received any anti-tumor therapy (including but not limited to chemotherapy, radiotherapy and targeted therapy, etc.) within 4 weeks before the first use of the study drug; traditional Chinese medicine or Chinese patent medicine with anti-tumor indications within 2 weeks; local palliative radiotherapy for the relief of bone metastasis pain within 2 weeks;
  • Abnormal coagulation function (INR > 1.5 or APTT > 1.5 × ULN); patients with bleeding tendency (such as active peptic ulcer) or receiving thrombolytic or anticoagulant therapy;
  • Urine routine showed urine protein ≥ + + and 24 h urine protein > 1.0 g;
  • Patients who have undergone major surgical procedures within 4 weeks before the first dose or are expected to undergo major surgery during the study;
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  • Patients with central nervous system (CNS) metastases who present with progressive neurological symptoms or require an increase in corticosteroid dose to control their CNS disease. If a patient requires treatment with corticosteroids for CNS disease, the dose must be stable for two weeks prior to the first dose;
  • Presence of poorly controlled pericardial, pleural, or peritoneal effusion;
  • Interstitial pneumonia requiring steroid therapy, drug-induced pneumonitis, radiation pneumonitis (except for stable radiation pneumonitis);
  • Significant cardiovascular disease, such as heart failure greater than New York Heart Association (NYHA) Class 2, unstable angina, serious arrhythmia, myocardial infarction or stroke within 6 months prior to the first dose, poorly controlled hypertension (defined as systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg on multiple measurements while on medication);
  • Patients who met any of the following criteria will be excluded:
  • QT interval (QTcF) value ≥ 470 ms for females and ≥ 450 ms for males; or congenital long QT syndrome, taking drugs known to prolong QT interval, family history of long QT syndrome;
  • Resting ECG showed any clinically significant abnormalities in rhythm, conduction, or morphology that required clinical intervention;
  • Cardiac ejection fraction less than 50%;
  • Patients with active hepatitis B virus or hepatitis C virus infection:
  • HBsAg positive with HBV DNA higher than the upper limit of normal range of the study site;
  • HCV antibody positive with HCV RNA higher than upper limit of normal range of the site;
  • Human immunodeficiency virus infected (HIV positive);
  • Inability or severe dysphagia;
  • Patients who have suffered from or are complicated with any other malignant tumor within 5 years (except radically resected skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, local prostate cancer, in situ cervical cancer or other carcinoma in situ);
  • Presence of any severe and/or uncontrolled disease that may affect the drug evaluation in the judgment of the investigator, including but not limited to: life-threatening autoimmune system diseases; drug abuse; severe nervous system diseases (such as epilepsy, dementia, etc.); history of severe mental disorders; severe infection, etc.;
  • Pregnant or lactating women;
  • Other conditions that, in the opinion of the investigator, make participation in the study unsuitable.

Trial locations and contacts

1 site in 1 country.

Ruihua Xu, Ph.D contact

86-20-87343468

xurh@sysucc.org.cn

China1 site, 1 recruiting

  • Sun Yat-sen University Cancer Centre

    Guangzhou, Guangdong, 510060

    Ruihua Xu, Ph.D, 86-20-87343468, xurh@sysucc.org.cn

    Recruiting

Other trials in China

About this study

Official title: 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

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).

Conditions
NSCLC
Being tested
HA121-28 tablet

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HA121-28 tabletDrug

    HA121-28 tablet, 450 mg, po, QD×21 days, every 4 weeks (28 days)

Study groups in NCT05117658
Study groupRoleWhat they receive
HA121-28ExperimentalPatients will receive HA121-28 tablets at 450 mg once daily (QD) for 21 days on a 28-day treatment cycle.
Receives: Drug: HA121-28 tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    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.

    Measured: Up to approximately 12 months

Secondary outcomes (9)

  1. ORR

    The percentage of patients who achieve a CR or PR evaluated by investigator according to RECIST 1.1.

    Measured: Up to approximately 12 months

  2. Progression-Free Survival (PFS)

    Time from date of the first dose to date of recorded disease progression or death, whichever occurs first.

    Measured: Up to approximately 12 months

  3. PFS

    Evaluated by investigator.

    Measured: Up to approximately 12 months

  4. Overall survival (OS)

    Time from date of the first dose to date of death from any cause.

    Measured: Up to approximately 24 months

  5. Disease Control Rate (DCR)

    The percentage of patients who achieve a CR, PR or stable disease (SD) evaluated by IRC.

    Measured: Up to approximately 12 months

  6. DCR

    Evaluated by investigator.

    Measured: Up to approximately 12 months

  7. Duration of Response (DOR)

    Time from first documented response (CR or PR, whichever occurs first, evaluated by IRC) to date of disease progression or death due to any cause, whichever occurs first.

    Measured: Up to approximately 12 months

  8. DOR

    Evaluated by investigator.

    Measured: Up to approximately 12 months

  9. Incidence of treatment-related adverse events (AEs) and serious adverse events (SAEs).

    The AEs and SAEs will be assessed according to the National Cancer Institute (NCI) CTCAE v5.0.

    Measured: Up to 28 days after the last administration of HA121-28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2021
  2. Study start18 Feb 2022
  3. Primary completionOct 2023 (estimated)
  4. Study completionOct 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
83 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05117658
Sponsor's protocol ID
HA122-CSP-004
Status last verified
Dec 2021
First submitted
1 Nov 2021
Last updated
4 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ruan DY, Huang WW, Li Y, Zhao Y, Shi Y, Jia Y, Cang S, Zhang W, Shi J, Chen J, Lin J, Liu Y, Xu J, Ouyang W, Fang J, Zhuang W, Liu C, Bu Q, Li M, Meng X, Sun M, Yang N, Dong X, Pan Y, Li X, Qu X, Zhang T, Yuan X, Hu S, Guo W, Li Y, Li S, Liu D, Song F, Tan L, Yu Y, Yu X, Zang A, Sun C, Zhang Q, Zou K, Dan M, Xu RH, Zhao H. 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. Signal Transduct Target Ther. 2025 Feb 28;10(1):62. doi: 10.1038/s41392-025-02155-5.

    PubMed 40016191

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HA121-28 tablet in people with NSCLC, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ruihua Xu, Ph.D (86-20-87343468, xurh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Up to approximately 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05117658, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022.

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