Description:
The purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule
assessed to be safe for Teclistamab and to characterize the safety and tolerability of
Teclistamab at the RP2Ds.
Title
- Brief Title: Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma
- Official Title: A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of Teclistamab, a Humanized BCMA x CD3 Bispecific Antibody in Subjects With Relapsed or Refractory Multiple Myeloma
Clinical Trial IDs
- ORG STUDY ID:
CR108206
- SECONDARY ID:
2016-002122-36
- SECONDARY ID:
64007957MMY1001
- NCT ID:
NCT03145181
Conditions
- Hematological Malignancies
Interventions
Drug | Synonyms | Arms |
---|
Teclistamab (IV) | JNJ-64007957 | Part 1: Dose Escalation (IV) |
Teclistamab(SC) | JNJ-64007957 | Part 1: Dose Escalation (SC) |
Purpose
The purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule
assessed to be safe for Teclistamab and to characterize the safety and tolerability of
Teclistamab at the RP2Ds.
Detailed Description
The study will be conducted in 2 parts, separately for IV and SC administration: dose
escalation (Part 1) and dose expansion (Part 2). It will evaluate safety, tolerability,
pharmacokinetics and preliminary antitumor activity of Teclistamab 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 2 years after the last participant in Part 3 has
received his or her initial dose of teclistamab. Study record NCT04557098 is Phase 2 part of
this study and study record NCT03145181 is Phase 1 part of this study.
Trial Arms
Name | Type | Description | Interventions |
---|
Part 1: Dose Escalation (IV) | Experimental | Participants will receive Teclistamab intravenously (IV). | |
Part 2: Dose Expansion (IV) | Experimental | Participants will receive Teclistamab IV. | |
Part 1: Dose Escalation (SC) | Experimental | Participants will receive Teclistamab subcutaneously (SC). | |
Part 2: Dose Expansion (SC) | Experimental | Participants will receive Teclistamab SC. | |
Eligibility Criteria
Inclusion Criteria:
- Documented diagnosis of multiple myeloma according to International Myeloma Working
Group (IMWG) diagnostic criteria
- Measurable multiple myeloma that is relapsed or refractory to established therapies
with known clinical benefit in relapsed/refractory multiple myeloma or be intolerant
of those established multiple myeloma therapies, and a candidate for Teclistamab
treatment in the opinion of the treating physician. Prior lines of therapy must
include a proteasome inhibitor, an immunomodulatory drug and anti-CD38 monoclonal
antibody in any order during the course of treatment. Participants who could not
tolerate a proteasome inhibitor or immunomodulatory drugs and an anti-CD38 monoclonal
antibody are allowed
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- Women of childbearing potential and fertile men who are sexually active must agree to
use a highly effective method of contraception (less than [<] 1%/year failure rate)
during the study and for 90 days after the last dose of study drug. Contraception must
be consistent with local regulations regarding the use of birth control methods for
participants participating in clinical trials. When a woman is of childbearing
potential the following are required: A woman using hormonal contraceptives must use
an additional barrier method (failure rate of <1% per year when used consistently and
correctly). Examples of highly effective contraceptives for women include
user-independent methods (for example, implantable progestogen-only hormone
contraception associated with inhibition of ovulation; intrauterine device;
intrauterine hormone-releasing system; vasectomized partner) and user-dependent
methods (for example: combined [estrogen- and progestogen-containing] hormonal
contraception associated with inhibition of ovulation [oral/intravaginal/
transdermal]; progestogen-only hormone contraception associated with inhibition of
ovulation [oral/injectable]. In addition to the highly effective method of
contraception, a man who is sexually active with a woman of childbearing potential
must agree to use a barrier method of contraception (for example a condom with
spermicidal foam/gel/film/cream/suppository). Additionally, a man who is sexually
active with a woman who is pregnant must use a condom. Women and men must agree not to
donate eggs (ova, oocytes) or sperm, respectively, during the study and for 90 days
after the last dose of study drug
- Participants must sign an informed consent form (ICF) indicating that he or she
understands the purpose of and procedures required for the study and is willing to
participate in the study. Consent is to be obtained prior to the initiation of any
study-related tests or procedures that are not part of standard-of-care for the
participant's disease
Exclusion Criteria:
- Prior treatment with any B cell maturation antigen (BCMA) targeted therapy
- Prior antitumor therapy as follows, before the first dose of study drug: Targeted
therapy, epigenetic therapy, or treatment with an investigational drug or used an
invasive investigational medical device within 21 days or at least 5 half-lives,
whichever is less; Monoclonal antibody treatment for multiple myeloma within 21 days;
Cytotoxic therapy within 21 days; Proteasome inhibitor therapy within 14 days;
Immunomodulatory agent therapy within 7 days; Gene modified adoptive cell therapy
(example, chimeric antigen receptor modified T cells, natural killer [NK] cells)
within 3 months; Radiotherapy within 14 days or focal radiation within & days
- Toxicities from previous anticancer therapies that have not resolved to baseline
levels or to Grade 1 or less except for alopecia or peripheral neuropathy
- Received a cumulative dose of corticosteroids equivalent to >= 140 milligram (mg) of
prednisone within the 14-day period before the first dose of study drug (does not
include pretreatment medication)
- Known active central nervous system (CNS) involvement or exhibits clinical signs of
meningeal involvement of multiple myeloma
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Dose Limiting Toxicity (DLT) |
Time Frame: | Up to Day 28 |
Safety Issue: | |
Description: | The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and defined as any of the following events: hematological / non hematological toxicity of Grade 3 or higher. |
Secondary Outcome Measures
Measure: | Teclistamab Serum Concentrations |
Time Frame: | Up to 8 weeks |
Safety Issue: | |
Description: | Concentration assessment will be done to evaluate the effect of Teclistamab. |
Measure: | Number of Participants with Teclistamab Antibodies |
Time Frame: | Up to 8 weeks |
Safety Issue: | |
Description: | Antibodies to Teclistamab will be assessed to evaluate potential immunogenicity. |
Measure: | Preliminary Antitumor Activity of Teclistamab at the RP2D(s) in Part 2 |
Time Frame: | Up to End of Treatment (Approximately 91 days) |
Safety Issue: | |
Description: | Preliminary antitumor activity of Teclistamab will be done using the International Myeloma Working Group (IMWG) response criteria. |
Measure: | Biomarker Assessment |
Time Frame: | Up to 8 weeks |
Safety Issue: | |
Description: | Biomarker assessment may be done to evaluate the effect of Teclistamab. |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Janssen Research & Development, LLC |
Last Updated
August 5, 2021