Evaluation of the safety and efficacy of the drug Veonetinib (AL8326) in the post-first treatment of small cell lung cancer, non small cell lung cancer and renal cell carcinoma.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Advenchen Pharmaceuticals LLC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

17 Jun 2025 → ongoing

Decision date (initial)

2025-02-10

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Advenchen Pharmaceuticals, LLC

External identifiers

EU CT number

2023-509067-24-01

ClinicalTrials.gov

NCT05363280

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Safety, Efficacy, Dose response, Pharmacokinetic

To determine the optimal biological dose (OBD) based on efficacy and safety of each dosing group for SCLC.
ORR for all dosing groups and OBD group plus expansion cohort for = or >2nd line treatment of AL8326 for SCLC patients.
ORR evaluation for NSCLC and RCC.

Secondary objectives 2

1. To measure duration of response (DOR) for SCLC, NSCLC and RCC expansion cohort study. Progression Free Survival (PFS). To characterize PK profile of single dose and multiple doses, and PK/PD/Efficacy/Safety exposure relationship for SCLC
2. To measure duration of response (DOR) for expansion cohort study. Progression Free Survival (PFS). To characterize PK profile of single dose and multiple doses, and PK/PD/Efficacy/Safety exposure relationship. Biomarker exploratory study.

Conditions and MedDRA coding

- Small Cell Lung Cancer (SCLC) patients who need ≥2nd line treatment without or with brain metastasis which is controlled with no active hemorrhage. - Non Small Cell Lung Cancer (NSCLC) patients who need ≥2nd line treatment with brain metastasis which is controlled with no active hemorrhage. - Renal Cell Carcinoma (RCC) patients who need ≥2nd line treatment.

Study design 2 periods

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 1. Male or female, 18 years of age or older. 2. ECOG performance status of 0 or 1. 3. Histologically or cytologically confirmed SCLC or advanced (not amenable to curativesurgery) non - small cell lung cancer (NSCLC), or advanced /metastatic renal cellcarcinoma (RCC, histopathological confirmed clear cell renal cell cancer or with acomponent of clear cell), which has received at least first - line standard care therapy andnow requires second, third, or fourth - line therapy). 4. Have at least 1 lesion that meets the criteria for being measurable, as defined by RECIST 1.1. 5. Have a life expectancy of at least 3 months (for SCLC and NSCLC); have a lifeexpectancy of ≥6 months (for RCC).

Exclusion criteria 1

1. Serious, non-healing wound, ulcer or bone fracture Major surgical procedure within 28 days or minor surgical procedure performed within 7 days prior to treatment Active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels Clinically significant cardiovascular disease including uncontrolled hypertension; myocardial infarction or unstable angina within 6 months prior to enrollment; New York Heart Association (NYHA) Grade II or greater congestive heart failure serious cardiac arrhythmia requiring medication; and Grade II or greater peripheral vascular disease Hemoptysis within 3 months prior to enrollment Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9 and CYP2C19 within 14 days prior to enrollment and during the study unless there is an emergent or life-threatening medical condition that required it.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. OBD and ORR for all dosing groups and OBD group plus expansion cohort for SCLC cohort. ORR for NSCLC and RCC cohort

Secondary endpoints 1

1. DOR and PFS for SCLC OBD group plus expansion cohort; NSCLC and RCC cohortgroup; ; Pharmacokinetic endpoints such as Cmax, AUC and other typic PK parameters; and PK/PD/Efficacy/Safety relationship for SCLC.

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Advenchen Pharmaceuticals LLC

Sponsor organisation

Advenchen Pharmaceuticals LLC

Address

887 Patriot Drive Suite A

City

Moorpark

Postcode

93021-3355

Country

United States

Scientific contact point

Organisation

Advenchen Pharmaceuticals LLC

Contact name

Shiying Sprinzl, CCRC Clinical Project Manager

Public contact point

Organisation

Advenchen Pharmaceuticals LLC

Contact name

Shiying Sprinzl, CCRC Clinical Project Manager

Third parties 3

Locations

2 EU/EEA countries · 9 investigational sites

By country

Investigational sites

Country notifications

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

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 1 · Art. 38 CTR

Results and documents

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

Documents 18 files

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

Application history

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