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NCT03550508: JMT103
Safety, Tolerability and PK/PD of JMT103 in Patients With Bone Metastases From Tumors
Phase 1 trial testing Anti-RANKL Monoclonal Antibody in Bone Metastases in 36 participants. Status unknown.
30 August 2019
Quick facts
| Lead sponsor | Shanghai JMT-Bio Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 36 |
| Start date | 21 May 2018 |
| Primary completion | 30 August 2019 |
| Estimated completion | 1 December 2019 |
| Sites | 1 location across China |
Drugs / interventions tested
- Anti-RANKL Monoclonal Antibody — full drug profile →
Conditions studied
- Bone Metastases — all drugs for Bone Metastases →
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):
-
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 -
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 -
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 -
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
Verify or expand the search:
- PubMed search for NCT03550508
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other Shanghai JMT-Bio Inc. trials
Trials by the same sponsor.
- NCT07441460 — A Phase III Study of KN026 in Combination With HB1801 as Adjuvant Therapy for Resectable HER2-Positive Breast Cancer · Phase 3 · recruiting
- NCT07472647 — SYS6090 Combination Therapy in Advanced Lung Cancer · Phase 1, PHASE2 · not yet recruiting
- NCT07384377 — JSKN003 Versus Physician Choiced Treatment in Patients With HER2-positive and Advanced Colorectal Cancer Who Had Failed · Phase 3 · not yet recruiting
- NCT07419698 — Evaluate the Safety, Tolerability, PK, and PD of JMT206 Injection in Healthy Participants · Phase 1 · recruiting
- NCT07332533 — A Study of KN026-based Combination Therapy in HER2-positive Gastric Cancer · Phase 2, PHASE3 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03550508 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai JMT-Bio Inc.
- Last refreshed: 8 June 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03550508.
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