Single Arm Study of WSD0922-FU for NSCLC Patients with C797S mutation

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Wayshine Biopharm Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

4 Sep 2025 → ongoing

Decision date (initial)

2025-07-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Wayshine Biopharm, Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To determine the recommended phase 2 dose [RP2D] and to assess the efficacy of WSD0922-FU by assessment of Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Secondary objectives 1

1. 1. To further assess the efficacy of WSD0922-FU in terms of: - Progression Free Survival (PFS) - Duration of Response (DoR) - Disease Control Rate (DCR) - Change in Tumor Size - Overall Survival (OS)

Conditions and MedDRA coding

Non-Small Cell Lung Cancer

Study design 1 period

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 12

1. 1. Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling and analyses.
2. 2. Male or female aged ≥18 years old.
3. 3. Histological or cytological confirmation diagnosis of NSCLC.
4. 4. Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy.
5. 5. Evidence of radiological disease progression.
6. 6. Documented EGFR mutation
7. 7. Patients must have confirmation of C797S mutation positive status.
8. 8.Eastern Cooperative Oncology Group (ECOG) 0-1.
9. 9. At least one lesion, not previously irradiated and not chosen for biopsy during the study.
10. 10. Females should be using adequate contraceptive measures.
11. 11. Male patients should be willing to use barrier contraception i.e., condoms.
12. 12. Patient must be stable on no more than 2 mg of dexamethasone.

Exclusion criteria 15

1. 1 Treatment with more than 2 prior lines of treatment for advanced NSCLC.Treatment with Osimertinib within 8 days of the first dose of study treatment.
2. 2. Any unresolved toxicities from prior therapy greater than CTCAE Grade 1.
3. 3. Symptomatic brain complications that require urgent neurosurgical or medical intervention.
4. 4. Leptomeningeal metastasis.
5. 5.Any evidence of severe or uncontrolled systemic diseases.
6. 6.Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection.
7. 7. Any of the following cardiac criteria: Mean resting corrected QT interval (QTc) > 480 msec, obtained from electrocardiograms (ECGs); Any clinically important abnormalities in rhythm; Any factors that increase the risk of QTc prolongation.
8. 8. Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
9. 9.Inadequate bone marrow reserve or organ function as demonstrated.
10. 10. History of hypersensitivity of WSD0922-FU.
11. 11. Males and females of reproductive potential who are not using an effective method of birth control.
12. 12. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
13. 13. Known intracranial hemorrhage which is unrelated to tumor.
14. 14. Seizures requiring a change.
15. 15. Patient must not take enzyme-inducing anticonvulsants treatment.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. To determine the recommended phase 2 dose [RP2D] and Objective Response Rate (ORR).

Secondary endpoints 1

1. 1. To further assess the efficacy of WSD0922-FU in terms of: - Progression Free Survival (PFS) - Duration of Response (DoR) - Disease Control Rate (DCR) - Change in Tumor Size - Overall Survival (OS)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Wayshine Biopharm Inc.

Sponsor organisation

Wayshine Biopharm Inc.

Address

957 Ferndale Drive

City

Corona

Postcode

92881-8751

Country

United States

Scientific contact point

Organisation

Wayshine Biopharm Inc.

Contact name

Wei Zhong

Public contact point

Organisation

Wayshine Biopharm Inc.

Contact name

Wei Zhong

Third parties 8

Locations

1 EU/EEA country · 5 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 20 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications