UnknownPhase 1/2

Efficacy and Safety of JMT103 in Patients With Giant Cell Tumor of Bone

China139 participantsStarted 2019-10-10

Plain-language summary

This is a phase Ib/II, multicenter, single-arm, open-label study to evaluate the efficacy and safety of JMT103 in patients with surgically unsalvageable or refractory giant cell tumor of bone (GCTB).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Fully informed and signed informed consent.
✓. Male or female, Adults, 18 years and older
✓. Histologically confirmed GCTB that is surgically unsalvageable or for which the planned surgery is associated with severe morbidity.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.

Exclusion criteria

✕. Fertile subjects refuse to use effective contraception methods from the signing of the informed consent to 6 months after the last dose;
✕. Active dental or jaw condition which requires oral surgery, including tooth extraction;
✕. Currently receiving other anti-tumor therapy (radiotherapy, chemotherapy or arterial embolization, etc.);
✕. Concurrent treatment with bisphosphonates;
✕. Known history of second malignancy within the past 5 years, except for basal cell carcinoma or cervical carcinoma in situ.

What they're measuring

Percentage of Participants with Giant Cell Tumor Response

Timeframe: From enrollment until 12 weeks

Trial details

NCT IDNCT04255576

SponsorShanghai JMT-Bio Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-09

View on ClinicalTrials.gov More Giant Cell Tumor of Bone trials