Recruiting NCT07490613
A Phase I Study of SHR-3836 in Patients With Multiple Myeloma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-3836 administered as multiple doses..
- Who it may be relevant to
- Registry conditions: Multiple Myeloma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open-label, Multicenter, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SHR-3836 in Patients With Multiple Myeloma
Overview
This is a Phase I, open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of SHR-3836 in patients with multiple myeloma (MM).
Interventions
- Drug SHR-3836 administered as multiple doses.
* In the dose escalation phase, doses are escalated sequentially from low to high levels. * In the dose expansion phase, one or more selected dose levels are further evaluated.
Primary outcome measures
- Determination of Phase II Dose (RP2D) of SHR-3836 [Time frame: 24 months]
Secondary outcome measures (4)
- Incidence and severity of adverse events (AE) of SHR-3836 [Time frame: 24 months]
- Maximum plasma concentration (Cmax) [Time frame: 24 months]
- Time to reach Cmax (Tmax) [Time frame: 24 months]
- Objective response rate (ORR) [Time frame: 24 months]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years, male or female
- Expected survival ≥ 3 months
- ECOG performance status 0 or 1
- Diagnosed with active multiple myeloma per IMWG criteria
- Relapsed or refractory multiple myeloma and refractory to the most recent line of therapy.
- Disease progression or non-response to the most recent therapy
- Measurable disease as defined by serum/urine M-protein or serum free light chain
- Adequate bone marrow, hepatic, renal, and coagulation function
- Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception
- Willing and able to provide written informed consent and comply with study procedures
Exclusion criteria
- Diagnosis of amyloidosis, plasma cell leukemia, Waldenström's macroglobulinemia, or POEMS syndrome.
- Central nervous system involvement by tumor.
- History of ≥ Grade 3 CRS with prior T-cell redirecting therapy.
- Requirement for dialysis or plasmapheresis within 14 days prior to study drug.
- Prior treatment-related AEs not recovered to ≤ Grade 1 (except alopecia, peripheral neuropathy, or controlled endocrinopathies).
- Concurrent participation in another clinical study.
- Prior anti-tumor therapy within specified washout periods.
- Major surgery within 28 days prior to informed consent or planned during the study.
- Live attenuated vaccine within 4 weeks prior to first dose or planned during the study.
- Significant comorbidity that in the investigator's judgment would interfere with study participation or safety.
- Active autoimmune disease (except controlled type I diabetes, hypothyroidism, or vitiligo).
- Active infection.
- Known hypersensitivity or contraindication to SHR-3836.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital of Soochow University — Suzhou
Identifiers
NCT: NCT07490613 · SHR-3836-101