Phase1/2 Study of IPH6501 in Patients With Relapsed /Refractory B-Cell Non-Hodgkin Lymphoma

• Sponsor: Innate Pharma (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06088654
• Collaborator: (none)
• Enrollment: 184
• Locations: 3
• Arm: 1
• Anticipated Duration (Months): 62.8
• Patients Per Site: 61.3
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

This is an international, first-in-human, multicenter, open-label Phase 1/2 study to evaluate the safety profile, tolerability of IPH6501, and determine the recommended phase 2 dose (RP2D) for patients with B-Cell non-Hodgkin lymphoma.

Condition or Disease	Intervention/Treatment	Phase
Non Hodgkin Lymphoma	Drug: IPH6501	Phase 1/Phase 2

Detailed Description

In Phase 1 - Dose finding, patients with advanced histologically confirmed, documented CD20+ B-cell non-Hodgkin lymphoma (NHL) will be enrolled. The dose finding part will include 2 sub-parts: Dose escalation will determine the Maximum Tolerated Dose (MTD) or the highest tested dose, Dose assessment will determine RP2D.

In Phase 2 - Dose expansion, one or more cohorts will be selected with patients with subtypes of advanced histologically confirmed, documented CD20+ B-cell non-Hodgkin lymphoma.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 184 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Anticipated Study Start Date: Oct 7, 2023
• Anticipated Primary Completion Date: Dec 31, 2028
• Anticipated Study Completion Date: Dec 31, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IPH6501 monotherapy	Drug: IPH6501; phase 1 (dose finding) and phase 2 (dose expansion)

Outcome Measures

Primary Outcome Measures

1. Safety and tolerability [From time of informed consent through treatment period and including the follow-up: up to 22 months]

   To evaluate the safety profile (including dose limiting toxicities (DLT(s), the maximum tolerated dose (MTD) or highest tested dose), tolerability and determine the recommended phase 2 dose (RP2D)

Secondary Outcome Measures

1. Objective Response Rate (ORR) [From time of informed consent through treatment period and including the follow-up: up to 22 months]

   To investigate any preliminary antitumor activity

2. Duration Of Response (DoR) [From time of informed consent through treatment period and including the follow-up: up to 22 months]

   To investigate any preliminary antitumor activity

3. Progression Free Survival (PFS) [From time of informed consent through treatment period and including the follow-up: up to 22 months]

   To investigate any preliminary antitumor activity

4. Maximum Observed Plasma Concentration (Cmax) [From time of informed consent through treatment period and including the follow-up: up to 22 months]

   To characterize and evaluate the pharmacokinetic profile of IPH6501

5. Area Under the Plasma Concentration (AUC) [From time of informed consent through treatment period and including the follow-up: up to 22 months]

   To characterize and evaluate the pharmacokinetic profile of IPH6501

6. Incidence of antidrug antibodies (ADA) against IPH6501 [From time of informed consent through treatment period and including the follow-up: up to 22 months]

   To evaluate the immunogenicity of IPH6501

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Main Inclusion criteria

• 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); high grade; thymic; Follicular Lymphoma (FL); Mantle cell lymphoma (MCL); Marginal zone lymphoma (MZL)

• Relapsed, progressive and/or refractory disease without established alternative therapy

• 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.

• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

• Adequate organ and hematological function

• Able to provide a fresh biopsy from a safely accessible site (or historical biopsy), per investigator determination.

Main Exclusion Criteria

• Patients with another invasive malignancy in the last 2 years

• Prior chemotherapy, immunotherapy or other anti-cancer therapy within less than 4 weeks before study drug administration.

• 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

• Subjects with brain or subdural metastases are not eligible, nor those with history of central nervous system (CNS) lymphoma

• Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease.

• Known history of infection with human immunodeficiency virus (HIV) or hepatitis B or C

• Major surgery within 4 weeks before the first dose of study drug

• Comorbidities including diabetes, cardiovascular diseases, immunodeficiencies/autoimmune condition

• Pregnant / breastfeeding woman

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
2	Monash Health	Clayton	Victoria	Australia
3	Peninsula Private Hospital	Frankston	Victoria	Australia	3910

Sponsors and Collaborators

• Innate Pharma

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Innate Pharma
• ClinicalTrials.gov Identifier: NCT06088654
• Other Study ID Numbers: IPH6501-101
• First Posted: Oct 18, 2023
• Last Update Posted: Oct 18, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Innate Pharma: ANKET®; NK cell engager; tetraspecific NK cell engager
• Additional relevant MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin

Study Results

No Results Posted as of Oct 18, 2023