An Open-Label, Phase 2 Trial of Nanatinostat in Combination with Valganciclovir in Patients with Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas (NAVAL-1)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Viracta Therapeutics Inc., Viracta Therapeutics Inc.

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

1 Oct 2021 → 11 Feb 2025

Decision date (initial)

2024-06-27

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Viracta Therapeutics, Inc.

External identifiers

EU CT number

2024-512717-41-00

EudraCT number

2020-005197-10

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Efficacy, Therapy

To evaluate the anti-tumor activity of the combination treatment of nanatinostat (Nstat) with valganciclovir (VGCV) based on objective tumor response rates

Secondary objectives 4

1. 1. To determine the duration of tumor control
2. 2. To determine survival outcomes
3. 3. To describe the safety profile of the combination treatment of Nstat with VGCV
4. 4. To generate pharmacokinetic (PK) data

Conditions and MedDRA coding

Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 12

1. 1. Adult patients age ≥18 years or as permitted by applicable local regulations at the time of providing informed consent. Patients must be able to swallow whole tablets. a. For patients with PTLD: Age ≥12 years and weighing ≥40 kg
2. 2. EBV+ relapsed/refractory lymphoma following 2 or more prior systemic therapies
3. 3. Patients must have received at least one course of an anti-CD20 immunotherapy, and at least one course of anthracycline-based chemotherapy
4. 4. Hodgkin lymphoma: Must have received at least one course of antracycline-based chemotherapy. Patients with classical Hodgkin lymphoma should have failed or be ineligible for an anti-PD-1 agent and CD30-directed therapy.
5. 5. For patients with ENKTL: Relapsed/refractory disease following 1 or more prior systemic therapies. Patients must have failed an a sparaginase-containing regimen.
6. 6. For patients with PTCL (PTCL, NOS and AITL): relapsed or refractory disease following 1 (2 for France) or more prior systemic therapies with a curative intent.
7. 7. For patients with PTLD: Patients with relapsed or refractory EBV+ PTLD who have received at least one prior therapy must have received at least one course of an antiCD20 immunotherapy such as rituximab. For solid-organ transplant (SOT) patients, prior therapy also includes chemotherapy, administered concurrently or sequentially, unless chemotherapy is inappropriate.
8. 8. No available therapies in the opinion of the investigator.
9. 9. Not eligible for high-dose chemotherapy with allogeneic/autologous stem cell transplantation or CAR-T Therapy.
10. 10. Measurable disease per Lugano 2007.
11. 11. ECOG performance status 0, 1, 2.
12. 12. Adequate bone marrow function.

Exclusion criteria 8

1. 1. Presence or history of central nervous system (CNS) involvement by lymphoma.
2. 2. Systemic anticancer therapy or CAR within 21 days.
3. 3. Antibody (anticancer) agents within 28 days.
4. 4. Less than 60 days from prior autologous hematopoietic stem cell or solid organ transplant.
5. 5. Less than 90 days from prior allogeneic transplant.
6. 6. Daily corticosteroids (≥20 mg of prednisone or equivalent) within week prior to Cycle 1 Day 1.
7. 7. Inability to take oral medication, malabsorption syndrome or any other gastrointestinal condition (nausea, diarrhea, vomiting) that may impact the absorption of nanatinostat and valganciclovir.
8. 8. Active infection requiring systemic therapy (Excluding viral upper respiratory tract infections.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Objective response rate (ORR) as assessed by an Independent Review Committee (IRC) per the 2007 International Working Group (IWG) criteria.

Secondary endpoints 6

1. 1. Duration of response (DOR)
2. 2. Time to next anti-lymphoma treatment
3. 3. Progression-free survival
4. 4. Time to progression
5. 5. Overall survival (OS)
6. 6. Pharmacokinetic (PK) parameters (eg, time to maximum plasma concentration [tmax], maximum plasma concentration [Cmax], area under the plasma concentration-time curve [AUC]).

Investigational products

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

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Viracta Therapeutics Inc.

Sponsor organisation

Viracta Therapeutics Inc.

Address

2533 South Coast Highway 101 Suite 210

City

Cardiff

Postcode

92007-2133

Country

United States

Scientific contact point

Organisation

Viracta Therapeutics Inc.

Contact name

Clinical Trial Information Desk

Public contact point

Organisation

Viracta Therapeutics Inc.

Contact name

Clinical Trial Information Desk

Third parties 9

Viracta Therapeutics Inc.

Sponsor organisation

Viracta Therapeutics Inc.

Address

2533 South Coast Highway 101 Suite 210

City

Cardiff

Postcode

92007-2133

Country

United States

Locations

4 EU/EEA countries · 26 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 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