A Phase 1/2, Open-Label, Multicenter Trial Investigating the Safety, Tolerability, and Preliminary Antineoplastic Activity of IPH6501 in Patients with Relapsed and/or Refractory CD20-expressing Non-Hodgkin Lymphoma

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Innate Pharma

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

16 May 2024 → 31 Jan 2026

Decision date (initial)

2024-03-25

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Innate Pharma SA

External identifiers

EU CT number

2023-506976-28-00

ClinicalTrials.gov

NCT06088654

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To evaluate the safety profile (including dose limiting toxicities (DLT(s), the maximum tolerated dose (MTD) or highest tested dose), tolerability according to National Cancer Institute-Common Terminology Criteria for Adverse Event v5.00 (NCI-CTCAE), and determine the recommended phase 2 dose (RP2D) of IPH6501

Secondary objectives 3

1. To investigate any preliminary antitumor activity of IPH6501 in terms of Objective Response Rate (ORR), Duration Of Response (DoR), Progression Free Survival (PFS).
2. To characterize and evaluate the pharmacokinetic (PK) profile of IPH6501
3. To evaluate the immunogenicity of IPH6501

Conditions and MedDRA coding

Relapsed and/or Refractory CD20-expressing Non-Hodgkin Lymphoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Phase 1- Dose finding 1. Patients with advanced histologically confirmed, documented CD20+ B-cell non-Hodgkin's lymphoma (NHL) including the following types defined by WHO 2016: • Diffuse Large B Cell Lymphoma (DLBCL) NOS (Not otherwise specified) • High-grade B-cell lymphoma NOS • Primary mediastinal (thymic) large B-cell lymphoma • Follicular Lymphoma (FL) • Mantle cell lymphoma (MCL) • Marginal zone lymphoma (MZL) (nodal, extranodal or splenic) For the patients with indolent forms of NHL (i.e., FL, MZL) patients must meet criteria to receive systemic therapy
2. Phase 2- Dose expansion 2. Patients with advanced histologically confirmed, documented CD20+ B-cell NHL defined by WHO 2016.
3. 3. Relapsed, progressive and/or refractory disease without established alternative therapy
4. 4. Must have received at least 2 prior systemic therapies including at a minimum anti-CD20 antibody therapy (e.g., rituximab) potentially in combination with chemotherapy and/or relapsed after autologous stem cell rescue.
5. 5. Male or Female, at least 18 years of age
6. 6. Measurable disease defined as at least one bi-dimensionally measurable nodal lesion, defined as > 1.5 cm in its longest dimension, or at least one bi-dimensionally measurable extranodal lesion, defined as > 1.0 cm in its longest dimension
7. 7. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
8. 8. Must have a life expectancy of at least 12 weeks.
9. 9. Toxicities due to prior therapy must be stable and recovered to ≤ Grade 1 (except for clinically non- significant toxicities such as alopecia)

Exclusion criteria 10

1. 1. Patients with another invasive malignancy in the last 2 years (with the exception of basal cell carcinoma and tumors deemed by the Investigator to be of low likelihood for recurrence)
2. 2. Prior chemotherapy, immunotherapy (tumor vaccine, cytokine or growth factor given to control the cancer) or other anti-cancer therapy within less than 4 weeks before study drug administration.
3. 3. Autologous stem cell transplant or treatment with CAR-T (Chimeric Antigen Receptor T-Cell) cell therapy within 100 days prior to first dose of study drug
4. 4. Live vaccine ≤ 6 weeks prior to first dose of study drug
5. 5. Use of other investigational drugs within 28 days
6. 6. Subjects with brain or subdural metastases are not eligible unless the metastases are asymptomatic and do not require treatment or have been adequately treated by local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks prior to study entry. In this protocol subjects with active brain metastasis are not eligible
7. 7. Current or past history of central nervous system (CNS) lymphoma
8. 8. Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease. Patients with a past history of stroke that have not experienced a stroke or transient ischemic attack in the past 2 years and have no residual neurologic deficits are allowed
9. 9. Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti‐HCV positive)
10. 10. Major surgery within 4 weeks before the first dose of study drug or minor surgery within 1 week (subject must also have recovered from any surgery related toxicities to less than CTCAE Grade 2)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. MTD or highest tested dose evaluation
2. Safety and tolerability analysis

Secondary endpoints 2

1. Efficacy analysis
2. Pharmacokinetics and Immunogenicity analysis

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Innate Pharma

Sponsor organisation

Innate Pharma

Address

117 Avenue De Luminy

City

Marseille

Postcode

13009

Country

France

Scientific contact point

Organisation

Innate Pharma

Contact name

Sonia Quarantino

Public contact point

Organisation

Innate Pharma

Contact name

Regulatory lead

Third parties 5

Locations

1 EU/EEA country · 6 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

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