A Phase 2 diagnostic study with 68Ga-EVG321 in Patients with Small Cell Lung Cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Evergreen Theragnostics Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Trial duration

16 Dec 2024 → ongoing

Decision date (initial)

2024-10-14

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Evergreen Theragnostics Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis, Safety, Pharmacokinetic

To assess the whole-body distribution and dosimetry of 68Ga-EVG321 in participants with histologically confirmed SCLC

Secondary objectives 3

1. To evaluate the safety and tolerability of 68Ga-EVG321
2. To determine the pharmacokinetics, biodistribution, and excretion of 68Ga-EVG321
3. Correlation of medical history to 68Ga-EVG321 uptake

Conditions and MedDRA coding

Small Cell Lung Cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Signed and dated ICF prior to any study-mandated procedure
2. Male or female participants aged 18 years old and above at the time of signing the ICF
3. ECOG performance status 0, 1 or 2
4. Participants with histologically or cytologically confirmed small cell lung cancer (SCLC)
5. Participants with evaluable ex-vivo tumour tissue
6. Participants of childbearing potential (WOCBP) must have a negative urine/serum pregnancy test. WOCBP who are sexually active, must use a highly effective/acceptable method of contraception from Visit 1 up to at least 14 days after discontinuation of study intervention. Allowed are accepted and effective non-hormonal methods of contraception and sexual abstinence or vasectomized partners (>3 months previously). Vasectomy has to be confirmed by two negative semen analyses
7. Male participants sexually active with a partner of childbearing potential must agree to use a male condom from the day of administration of study intervention up to at least 14 days after or have documented permanent sterilization by vasectomy. They agree not to donate semen during the study period and for 14 days after study termination

Exclusion criteria 12

1. Other known co-existing malignancies with clinical relevance except participants with a history of malignant tumors complete remission >3 years, with no evidence of recurrence <5 years
2. Organ allograft requiring immunosuppressive therapy
3. Significantly impaired organ function that may interfere with the excretion and metabolism of the imaging agent. Specifically, participants will be excluded if they meet the following criteria: • Hematologic (Platelets <75K/mcL; ANC <1.0 K/mcL) • Hepatic (Bilirubin >2.0 x ULN; AST/ALT >2.5 x ULN) • Renal (eGFR or creatinine clearance <30 mL or Creatinine > 2.0 x ULN)
4. Claustrophobia interfering with PET/CT imaging
5. Clinically abnormal ECG (signs of ischemia, high grade ventricular arrhythmia, high grade supra-ventricular arrhythmia)
6. Pregnancy, breast-feeding
7. Participants with bladder outflow obstruction or unmanageable urinary incontinence
8. Known hypersensitivity to gallium-68, EVG321 or to any of the excipients of the IMP
9. Any condition that precludes raised arms position for prolonged imaging purposes
10. Prior administration of a radiopharmaceutical within a period corresponding to 8 half-lives of the radionuclide used on such radiopharmaceutical
11. Persons with any kind of dependency on the investigator or employed by the sponsor or investigator
12. Persons held in an institution by legal or official order

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Quantitative measurements of 68Ga-EVG321 radioactivity in volumes of interest (VOIs) from whole-body images over target organs will be made at several time points

Secondary endpoints 3

1. Safety and tolerability, including treatment emergent adverse events and pre/post-68Ga-EVG321 PET/CT lab values, ECGs and vital signs
2. Pharmacokinetic parameters [e.g., Cmax, area under the curve (AUC), total clearance (CL), steady-state volume of distribution (Vss) and mean residence time (MRT)] of 68Ga- EVG321 in both healthy tissues and primary/metastatic lesions
3. Comparison of 68Ga-EVG321 PET/CT imaging to determine the presence of CCK2R expressing SCLC relative to histopathology

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Evergreen Theragnostics Inc.

Sponsor organisation

Evergreen Theragnostics Inc.

Address

27 Commerce Street

City

Springfield

Postcode

07081-3014

Country

United States

Scientific contact point

Organisation

Evergreen Theragnostics Inc.

Contact name

Dalma Seboek

Public contact point

Organisation

Evergreen Theragnostics Inc.

Contact name

Dalma Seboek

Third parties 1

Locations

3 EU/EEA countries · 3 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 13 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