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A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05652335
Collaborator
(none)
90
Enrollment
17
Locations
2
Arms
29.3
Anticipated Duration (Months)
5.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary purpose of this study is to identify the recommended phase 2 dose (RP2D[s]) and schedule(s) to be safe for JNJ-79635322 in Part 1 (dose escalation), and to characterize the safety and tolerability of JNJ-79635322 at the RP2D(s) in Part 2 (dose expansion).

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

The study will be conducted in 2 parts: dose escalation (Part 1) and dose expansion (Part 2). It will evaluate safety, tolerability, pharmacokinetics and preliminary antitumor activity of JNJ-79635322 administered to adult participants with relapsed or refractory multiple myeloma. The overall safety of the study drug will be assessed by physical examinations, Eastern Cooperative Oncology Group performance status, laboratory tests, vital signs, electrocardiograms, adverse event monitoring, and concomitant medication usage. Disease evaluations will include peripheral blood and bone marrow assessments at screening (performed within 28 days) and to confirm stringent complete response (sCR), complete response (CR), or relapse from CR. The end of study (study completion) is defined as the last study assessment for the last participant on study.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase 1, First-in-Human, Dose Escalation Study of JNJ-79635322, a Trispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma
Actual Study Start Date :
Nov 22, 2022
Anticipated Primary Completion Date :
Apr 18, 2025
Anticipated Study Completion Date :
May 2, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part 1: Dose Escalation

Participants will receive JNJ-79635322. The dose will be escalated sequentially until the recommended phase 2 dose (RP2D) regimen(s) have been identified.

Drug: JNJ-79635322
JNJ-79635322 will be administered as SC injection.
Experimental: Part 2: Dose Expansion

Participants will receive JNJ-79635322 at the RP2D regimen(s) determined in Part 1.

Drug: JNJ-79635322
JNJ-79635322 will be administered as SC injection.

Outcome Measures

Primary Outcome Measures

  1. Part 1: Number of Participants with Dose-limiting Toxicity (DLT) [Up to 2 years 5 months]

    DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.

  2. Parts 1 and 2: Number of Participants with Adverse Events (AEs) by Severity [Up to 2 years 5 months]

    An adverse event is any untoward medical occurrence in a clinical study participant that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from grade 1 (mild) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event.

  3. Part 2: Number of Participants with Abnormalities in Laboratory Values [Up to 2 Years 5 months]

    Number of participants with abnormalities in laboratory values (hematology and chemistry) will be reported.

Secondary Outcome Measures

  1. Serum Concentration of JNJ-79635322 [Up to 2 Years 5 months]

    Serum samples will be analyzed to determine concentrations of JNJ-79635322.

  2. Number of Participants with Presence of Anti-Drug Antibodies to JNJ-79635322 [Up to 2 Years 5 months]

    Number of participants with presence of anti-drug antibodies to JNJ-79635322 will be reported.

  3. Preliminary Anticancer Activity of JNJ-79635322 [Up to 2 Years 5 months]

    Preliminary anticancer activity of JNJ-79635322 will be assessed according to the International Myeloma Working Group (IMWG) 2016 response criteria.

  4. Time to Response (TTR) [Up to 2 Years 5 months]

    TTR is defined as the time between date of first dose of study drug and the first efficacy evaluation at which the participant has met all criteria for PR or better as defined by IMWG 2016 response criteria.

  5. Duration of Response (DOR) [Up to 2 Years 5 months]

    DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), per IMWG 2016 response criteria, or death due to any cause, whichever occurs first.

Eligibility Criteria

Criteria

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

  • Have a documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria

  • Have relapsed or refractory disease and have been treated with a proteasome inhibitor, immunomodulatory drug (IMiD) agent, and an anti-CD38-based therapy for the treatment of multiple myeloma (MM)

  • Must have an Eastern Cooperative Oncology Group (ECOG) status of 0 or 1

  • Have measurable disease at screening as defined by at least 1 of the following: a) Serum M-protein level greater than or equal to (>=) 0.5 grams per deciliter (g/dL); or

  1. Urine M-protein level >=200 milligrams (mg)/24 hours; or c) Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) >=10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio; d) For participants without measurable disease in the serum, urine, or involved FLC, presence of plasmacytomas (>=2 centimeter [cm])
Exclusion Criteria:

  • Central Nervous System (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required

  • Active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary light chain amyloidosis

  • Received a cumulative dose of corticosteroids equivalent to greater than (>) 140 mg of prednisone within the 14-day period before the start of study treatment administration

  • Prior antitumor therapy within 21 days prior to the first dose of study treatment (proteasome inhibitor [PI] therapy or radiotherapy within 14 days, immunomodulatory drug (IMiD) agent therapy within 7 days, gene -modified adoptive cell therapy or CD-3 redirecting therapy within 90 days)

  • Prior allogeneic transplant within 6 months or autologous transplant within 12 weeks

  • Live, attenuated vaccine within 4 weeks before the first dose of study treatment

  • Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline levels or to Grade less than or equal to (<=) 1 (except alopecia, tissue post-RT fibrosis [any grade] or peripheral neuropathy to Grade <=3)

  • The following medical conditions: pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation, human immunodeficiency (HIV) infection, active hepatitis B or C infection, stroke or seizure within 6 months prior to first dose of study treatment, autoimmune disease, serious active viral or bacterial infection, uncontrolled systemic fungal infection, cardiac conditions (myocardial infarction <=6 months prior to enrollment, New York Heart Association stage III or IV congestive heart failure, etc)

Contacts and Locations

Locations

Site City State Country Postal Code
1 UZ Antwerpen Edegem Belgium 2650
2 UZ Gent Gent Belgium 9000
3 CHU de Liège Liege Belgium 4000
4 CHU Nantes Nantes France 44093
5 CHU Lyon Sud Pierre benite France 69495
6 Chu Rennes - Hopital Pontchaillou Rennes France 35000
7 Institut Claudius Regaud Toulouse France 31100
8 VUMC Amsterdam Amsterdam Netherlands 1081 HV
9 UMC Utrecht Utrecht Netherlands 3584 CX
10 Hosp. Univ. Germans Trias I Pujol Badalona Spain 08916
11 Hosp. Clinic I Provincial de Barcelona Barcelona Spain 08036
12 Hosp. Univ. Fund. Jimenez Diaz Madrid Spain 28040
13 Clinica Univ. De Navarra Pamplona Spain 31008
14 Hosp. Clinico Univ. de Salamanca Salamanca Spain 37007
15 University College Hospital London United Kingdom W1T 7HA
16 The Christie NHS Foundation Trust - Christie Hospital Manchester United Kingdom M20 4BX
17 Royal Marsden Hospital Sutton United Kingdom SM2 5PT

Sponsors and Collaborators

  • Janssen Research & Development, LLC

Investigators

  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT05652335
Other Study ID Numbers:
  • CR109234
  • 2022-001465-12
  • 79635322MMY1001
First Posted:
Dec 15, 2022
Last Update Posted:
Jan 30, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell

Study Results

No Results Posted as of Jan 30, 2023