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

Sponsored by Shanghai JMT-Bio Inc.

About this trial

Last updated 3 years ago

Study ID

JMT103CN03

Status

Active, not recruiting

Type

Interventional

Phase

Phase 1/Phase 2

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 2 years ago

What is this trial about?

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).

What are the participation requirements?

Yes

Inclusion Criteria

1. Fully informed and signed informed consent.

2. Male or female, Adults, 18 years and older

3. Histologically confirmed GCTB that is surgically unsalvageable or for which the planned surgery is associated with severe morbidity.

4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.

No

Exclusion Criteria

1. Fertile subjects refuse to use effective contraception methods from the signing of the informed consent to 6 months after the last dose;

2. Active dental or jaw condition which requires oral surgery, including tooth extraction;

3. Currently receiving other anti-tumor therapy (radiotherapy, chemotherapy or arterial embolization, etc.);

4. Concurrent treatment with bisphosphonates;

5. Known history of second malignancy within the past 5 years, except for basal cell carcinoma or cervical carcinoma in situ.

Locations

Location

Status