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

NCT ID: NCT04255576

Last Updated: 2022-10-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 139 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-10
• Study Completion Date: 2023-10-31

Brief 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).

Detailed Description

The objective of the trial is to evaluate the efficacy and safety of JMT103 in patients with GCTB that is surgically unsalvageable or for which the planned surgery is associated with severe morbidity.

This study consists of two parts (phase Ib and II). In the phase Ib part, 6 to 12 subjects will be enrolled, and the safety, pharmacokinetics and pharmacodynamics of JMT103 will be evaluated after treatment for more than 4 weeks. And then the phase II part will be conducted, in which, 125 subjects will be enrolled.

Eligible subjects will receive JMT103 at a dose of 2mg/kg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 2mg/kg SC on study days 8 and 15 until disease progression, tumor resection (the pathologic outcome after surgical resection is CR or PR), intolerable toxicity, decision by the participant to discontinue, or decision by the investigator that the subject could no longer benefit from the treatment (whichever occurs first).

Conditions

Giant Cell Tumor of Bone

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: JMT103

Eligible subjects will receive JMT103 at a dose of 2 mg/kg SC Q4W with a loading dose of 2 mg/kg SC on study days 8 and 15.

Group Type: EXPERIMENTAL

Dietary Supplement: Calcium/Vitamin D

Intervention Type: DIETARY_SUPPLEMENT

All subjects should be adequately supplemented with calcium and vitamin D (at least 500 mg of calcium and 400 IU of vitamin D), except in the case of pre-existing hypercalcemia.

Interventions

Dietary Supplement: Calcium/Vitamin D

All subjects should be adequately supplemented with calcium and vitamin D (at least 500 mg of calcium and 400 IU of vitamin D), except in the case of pre-existing hypercalcemia.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai JMT-Bio Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Ji Shui Tan Hospital

Beijing, , China

Countries

China

References

Xu H, Zhou Y, Liang L, Shen J, Yan W, Wang J, Li J, Zhang X, Huang G, Bi W, Guo Z, Xiao Y, Lin J, Yao W, Tong Z, Zhou W, Zhang G, Ye Z, Wang D, Yang J, Fan Z, Liu C, Qu G, Zhang Q, Wei F, Liu W, Tu C, Li H, Yuan J, Niu X. Efficacy and safety of JMT103 in patients with unresectable or surgically-challenging giant cell tumor of bone: a multicenter, phase Ib/II study. Nat Commun. 2024 Nov 5;15(1):9541. doi: 10.1038/s41467-024-53686-4.

Reference Type: DERIVED

PMID: 39500883 (View on PubMed)

Other Identifiers

JMT103CN03

Identifier Type: -

Identifier Source: org_study_id