A Study of JNJ-95566692 in Participants With Non-Hodgkin Lymphoid Malignancies

Phase 1RecruitingNCT07308132

Janssen Research & Development, LLC340 enrolled

Overview

The purpose of this study is to determine the putative recommended Phase 2 doses (RP2Ds) and optimal dose schedule(s) for JNJ-95566692 as a single agent (Arm A) and in combination with JNJ-87801493 (Arm B) and for JNJ-95566692 with or without JNJ-87801493 with various standard of care (SOC) regimens (Arms C-G) in Part 1: Dose Escalation part of the study. Part 2: Dose Expansion part of the study will further characterize the safety.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

340

Conditions

Lymphoma, Non-Hodgkin

Interventions

JNJ-95566692DRUG

JNJ-95566692 will be administered subcutaneously.

JNJ-87801493DRUG

JNJ-87801493 will be administered subcutaneously.

loncastuximab tesirineDRUG

Loncastuximab tesirine will be administered intervenously.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * B-cell non-Hodgkin lymphoid malignancies (NHL) according to World Health Organization (WHO) 2022 and no other approved therapies available that would be more appropriate in the investigator's judgment. -Histologic documentation of the following large B-cell lymphomas: -diffuse large B-cell lymphoma not otherwise specified (NOS), -T-cell/histiocyte-rich large B-cell lymphoma, -diffuse large B-cell lymphoma/high grade B-cell lymphoma with MYC and BCL2 rearrangements, -large B-cell lymphoma with IRF4 rearrangement, -high grade B-cell lymphoma with 11q aberrations, -Epstein-Barr virus (EBV)-positive diffuse large B-cell lymphoma, -diffuse large B-cell lymphoma associated with chronic inflammation, -primary large B-cell lymphoma of immune privileged sites, -primary cutaneous diffuse large B-cell lymphoma-leg type , -primary mediastinal large B-cell lymphoma, -high-grade B-cell lymphoma NOS, -transformations of indolent B-cell lymphoma (For US sites). -Other B-cell NHL may be enrolled based on emerging data in specific cohorts as stipulated by study evaluation team (SET) * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 * Participants must have measurable disease as defined by the disease criteria (Lugano criteria) * While on study treatment and for 3 months after the last dose of study treatment, a participant must: not breastfeed or become pregnant; not donate gametes (that is, eggs or sperm) or freeze for future use for the purposes of assisted reproduction; and wear an external condom; -Participants of childbearing potential must have a negative highly sensitive (for example, beta \[β\]-human chorionic gonadotropin) pregnancy test at screening and within 24 hours before the first dose of study treatment and agree to further pregnancy tests, -For Arm E ONLY: Practice 2 methods of reliable birth control simultaneously, including 1 highly effective form of contraception and 1 additional effective contraceptive method., -Participants on Arms C-G should also follow the pregnancy and contraception restrictions in the respective local corresponding product label Exclusion Criteria: * Known active central nervous system involvement (CNS) or leptomeningeal involvement * Prior solid-organ transplantation * Malignancy diagnosis other than the disease under study within 1 year prior to the first dose of the study treatment; exceptions are squamous and basal cell carcinoma of the skin, carcinoma in situ of the cervix and any malignancy that is considered cured or has minimal risk of recurrence within 1 year of first dose of the study treatment in the opinion of both the investigator and sponsor's medical monitor * Autoimmune or inflammatory disease requiring systemic steroids or other immunosuppressive agents (for example, methotrexate or tacrolimus) within 3 months prior to first dose of study treatment * Toxicity from prior anticancer therapy that has not resolved to baseline levels or to Grade less than or equal to (\<=) 1 (except alopecia, vitiligo, peripheral neuropathy, or Grade \<=2 endocrinopathies that are stable on hormone replacement)

Locations (19)

Monash Medical Centre

Clayton, Australia

RECRUITING

Outcomes

Primary Outcomes

Part 1 and 2: Number of Participants with Adverse Events (AEs) And Serious Adverse Events (SAEs) by Severity

An AE is any untoward medical occurrence in a clinical study participant administered an investigational or non-investigational product and it does not necessarily have a causal relationship with the investigational product. Severity for AEs will be specified as per: National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grades which are Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (potentially life-threatening) and Grade 5 (death related to adverse event). SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.

Time frame: Approximately 2 years and 8 months

Part 1: Number of Participants with Dose Limiting Toxicity (DLTs)

Number of participants with DLTs for JNJ-95566692 (arm A), in combination with JNJ-87801493 (arm B) and in arms C to G will be reported. The DLTs are drug-related toxicities and are defined as any of the following: fatal toxicity, high grade non-hematologic toxicity, or hematologic toxicity.

Time frame: Approximately 2 years and 8 months

Secondary Outcomes

Serum Concentration for JNJ-95566692 (Arms A-G) And JNJ-87801493 (Arms B-G)

Serum concentration for JNJ-95566692 (Arms A-G) and JNJ-87801493 (Arms B-G), where applicable will be assessed using a validated assay method.

Time frame: Approximately 2 years and 8 months

Area Under the Curve During a Dosing Interval (AUCtau) in JNJ-95566692 (Arms A-G) And JNJ-87801493 (Arms B-G)

AUC tau is defined as area under the serum concentration-time curve during a dosing interval (tau).

Time frame: Approximately 2 years and 8 months

Central Contacts

Study Contact

CONTACT

844-434-4210 Participate-In-This-Study1@its.jnj.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Lenalidomide will be administered orally.

RituximabDRUG

Rituximab will be administered intravenously and may be administered subcutaneously after the first administration.

GemcitabineDRUG

Gemcitabine will be administered intravenously.

OxaliplatinDRUG

Oxaliplatin will be administered intravenously.

CyclophosphamideDRUG

Cyclophosphamide will be administered intravenously.

DoxorubicinDRUG

Doxorubicin will be administered intravenously.

VincristineDRUG

Vincristine will be administered intravenously.

PrednisoneDRUG

Prednisone will be administered orally.

Polatuzumab vedotinDRUG

Polatuzumab vedotin will be administered intravenously.

Peter MacCallum Cancer Centre

Melbourne, Australia

RECRUITING

Macquarie University Hospital

North Ryde, Australia

RECRUITING

Scientia Clinical Research

Randwick, Australia

RECRUITING

UZ Antwerpen

Edegem, Belgium

RECRUITING

Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman

Liège, Belgium

RECRUITING

Hopital Claude Huriez

Lille, France

RECRUITING

CHU Pitie Salpetriere

Paris, France

RECRUITING

CHU Lyon Sud

Pierre-Bénite, France

RECRUITING

Institut Universitaire du Cancer Toulouse Oncopole

Toulouse, France

RECRUITING

...and 9 more locations

Maximum Serum Concentration (Cmax) for JNJ-95566692 (Arms A-G) And JNJ-87801493 (Arms B-G)

Cmax for JNJ-95566692 (Arms A-G) and JNJ-87801493 (Arms B-G), where applicable will be reported.

Time frame: Approximately 2 years and 8 months

Minimum Serum Concentration (Cmin) for JNJ-95566692 (Arms A-G) And JNJ-87801493 (Arms B-G)

Cmin for JNJ-95566692 (Arms A-G) and JNJ-87801493 (Arms B-G), where applicable will be reported.

Time frame: Approximately 2 years and 8 months

Area Under the Curve (AUC[0-t]) for JNJ-95566692 (Arms A-G) And JNJ-87801493 (Arms B-G)

AUC(0-t) for JNJ-95566692 (Arms A-G) and JNJ-87801493 (Arms B-G), where applicable will be reported.

Time frame: Approximately 2 years and 8 months

Half-life (t1/2) for JNJ-95566692 (Arms A-G) And JNJ-87801493 (Arms B-G)

Half-life (t1/2) for JNJ-95566692 (Arms A-G) and JNJ-87801493 (Arms B-G), where applicable will be reported.

Time frame: Approximately 2 years and 8 months

Time to Reach Cmax (Tmax) for JNJ-95566692 (Arms A-G) And JNJ-87801493 (Arms B-G)

Tmax is the time to reach maximum observed serum concentration for JNJ-95566692 (Arms A-G) and JNJ-87801493 (Arms B-G), where applicable will be reported.

Time frame: Approximately 2 years and 8 months

Apparent Total Body Clearance (CL/F) for JNJ-95566692 (Arms A-G) And JNJ-87801493 (Arms B-G)

CL/F for JNJ-95566692 (Arms A-G) and JNJ-87801493 (Arms B-G), where applicable will be reported.

Time frame: Approximately 2 years and 8 months

Apparent Volume of Distribution (V/F) for JNJ-95566692 (Arms A-G) And JNJ-87801493 (Arms B-G)

V/F for JNJ-95566692 (Arms A-G) and JNJ-87801493 (Arms B-G), where applicable will be reported.

Time frame: Approximately 2 years and 8 months

Number of Participants with Anti-JNJ-95566692 Antibodies in Arms A to G

Participants with presence of antibodies binding to JNJ-95566692 in arm A to G will be reported.

Time frame: Approximately 2 years and 8 months

Number of Participants with Anti-JNJ-87801493 Antibodies in Arms B to G

Participants with presence of antibodies binding to JNJ-87801493 in arm B to G (as appropriate) will be reported.

Time frame: Approximately 2 years and 8 months

Part 2: Overall Response for JNJ-95566692 (Arm A), in Combination With JNJ-87801493 (Arm B) And for JNJ-95566692 ± JNJ-87801493 with Combination Therapies In Arms C to G

Overall response is defined as a best response of partial response (PR) or better as assessed by the investigator according to standard response criteria per Lugano.

Time frame: Approximately 2 years and 8 months

Part 2: Complete Response (CR) for JNJ-95566692 (Arm A), in Combination With JNJ-87801493 (Arm B) And for JNJ-95566692 ± JNJ-87801493 with Combination Therapies In Arms C to G

Complete response (CR) is defined as a best response of CR as assessed by the investigator according to standard response criteria per Lugano.

Time frame: Approximately 2 years and 8 months

Part 2: Time to Response (TTR) for JNJ-95566692 (Arm A), in Combination With JNJ-87801493 (Arm B) And for JNJ-95566692 ± JNJ-87801493 with Combination Therapies In Arms C to G

TTR is defined for participants who achieved a response of PR or better as the time from the first dose of study treatment to the first response of PR or better.

Time frame: Approximately 2 years and 8 months

Part 2: Duration of Response (DOR) for JNJ-95566692 (Arm A), in Combination With JNJ-87801493 (Arm B) And for JNJ-95566692 ± JNJ-87801493 with Combination Therapies In Arms C to G

DOR is defined for participants who achieved a response of PR or better as the time between the date of initial documentation of first response of PR or better to the date of first documented evidence of progressive disease, initiation of a new systemic anti-cancer therapy or death.

Time frame: Approximately 2 years and 8 months