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NCT03550508: JMT103

Safety, Tolerability and PK/PD of JMT103 in Patients With Bone Metastases From Tumors

Status unknown Phase 1 Last updated 8 June 2018
What this trial tests

Phase 1 trial testing Anti-RANKL Monoclonal Antibody in Bone Metastases in 36 participants. Status unknown.

Timeline
21 May 2018
Primary endpoint
30 August 2019
1 December 2019

Quick facts

Lead sponsorShanghai JMT-Bio Inc.
PhasePhase 1
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment36
Start date21 May 2018
Primary completion30 August 2019
Estimated completion1 December 2019
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Shanghai JMT-Bio Inc. — full company profile →

Who can join

Adults 18 to 75, any sex, with Bone Metastases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

JMT103 is a novel, full human IgG4 monoclonal antibody targeting RANKL. In preclinical studies, JMT103 demonstrated strong activity through blocking RANKL receptor, RANK on the surface of osteoclasts, leading to inhibit osteoclast differentiation, activation, and maturation and reduce bone resorption. This first-in-human study is conducted to assess the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) ,to evaluate the safety, pharmacokinetics and preliminary efficacy (bone turnover markers) of recombinant fully human Anti-RANKL Monoclonal Antibody (JMT103) in patients with bone metastases from tumors at single doses and multiple doses. About 36 cases patients are to be recruited.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Antibodies to watch in 2023.
    Kaplon H, Crescioli S, Chenoweth A, Visweswaraiah J, et al · · 2023 · cited 204× · PMID 36472472 · DOI 10.1080/19420862.2022.2153410
  2. Cancer Cells Exploit Notch Signaling to Redefine a Supportive Cytokine Milieu.
    Colombo M, Mirandola L, Chiriva-Internati M, Basile A, et al · · 2018 · cited 51× · PMID 30154786 · DOI 10.3389/fimmu.2018.01823
  3. Chemokines network in bone metastasis: Vital regulators of seeding and soiling.
    Sharma G, Pothuraju R, Kanchan RK, Batra SK, et al · · 2022 · cited 14× · PMID 35124194 · DOI 10.1016/j.semcancer.2022.02.003
  4. Safety, tolerability, and pharmacokinetics/pharmacodynamics of JMT103 in patients with bone metastases from solid tumors.
    Liang X, Xue J, Ge X, Li J, et al · · 2022 · cited 8× · PMID 35992822 · DOI 10.3389/fonc.2022.971594

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Other recruiting trials for Bone Metastases

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