Feasibility clinical trial of the combination of AloCelyvir with chemotherapy and radiotherapy for the treatment of children and adolescents with relapsed or refractory extracranial solid tumors.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacion Para La Investigacion Biomedica Hospital Infantil Universitario Nino Jesus

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2024-10-10

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-518417-25-00

EudraCT number

2019-001154-26

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Safety

Dose confirmation phase: to evaluate the safety of the combination of AloCelyvir added to the cytoreductor scheme (combination of chemotherapy, surgery, radiotherapy).

Secondary objectives 6

1. Expansion phase: To measure antitumor activity (measured as objective response rate [complete response and partial response]) of the combination).
2. Feasibility of the combination.
3. Antitumor activity (dose confirmation phase).
4. Security (Expansion phase).
5. Calculation of progression-free survival.
6. Calculation of global survival.

Conditions and MedDRA coding

Relapsed or refractory extracranial solid tumors in children and adolescents.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. Patients aged between 1 year and ≤21 years.
2. Patients with extra-cranial solid tumor, relapsed or refractory, for which there is no standard curative treatment
3. Disease measurable or evaluable according to RECIST criteria v1.1.
4. Patients for whom the combination with the proposed chemotherapy and radiotherapy regimens is considered adequate. Patients may have previously received the same schemes.
5. Adequate functional status, organic function (renal, hepatic) and hematological values.
6. Patient capable of complying with the treatment and plan of visits and evaluations.
7. Life expectancy ≥3 months.
8. Appropriate contraceptive methods for sexually active men and women of childbearing age.
9. Negative pregnancy test for women of childbearing age.
10. Informed consent in writing according to current legislation.
11. Washing periods compared to previous treatments.

Exclusion criteria 7

1. Previous treatment with Celyvir.
2. Active acute toxicities of previous treatment grade ≥3 of the CTCAE v4.
3. Known and uncontrolled bacterial, viral, fungal or parastaria active infection.
4. Known active infection for hepatitis or HIV virus.
5. Patients with CNS metastases should be clinically stable and with stable or decreasing doses of steroids for at least one week.
6. Serious active and past systemic diseases that are clinically significant or uncontrolled, which may imply an added risk for the patient.
7. Allergy to Penicillin or its derivatives.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Dose confirmation phase: Rate of dose-limiting toxicities.

Secondary endpoints 6

1. Expansion phase: Rate of objective responses (complete and partial responses) of the combination.
2. Feasibility of the combination: rate of patients who meet selection criteria who can receive at least one cycle of the combination of Alo-Celyvir with chemo-radiotherapy and measurement of the time from recruitment to the preparation and administration of Alo-Celyvir.
3. Dose confirmation phase: Rate of objective responses (complete and partial responses) of the combination.
4. Progression free survival.
5. Global survival.
6. Rate of adverse events.

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacion Para La Investigacion Biomedica Hospital Infantil Universitario Nino Jesus

Sponsor organisation

Fundacion Para La Investigacion Biomedica Hospital Infantil Universitario Nino Jesus

Address

Avenida Menendez Pelayo 65

City

Madrid

Postcode

28009

Country

Spain

Scientific contact point

Organisation

Fundacion Para La Investigacion Biomedica Hospital Infantil Universitario Nino Jesus

Contact name

Manuel Ramírez Orellana

Public contact point

Organisation

Fundacion Para La Investigacion Biomedica Hospital Infantil Universitario Nino Jesus

Contact name

Gina Paola Mejía Abril

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Application history

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