A PHASE IB/II STUDY TO EVALUATE SAFETY AND EFFICACY OF BEXMARILIMAB IN COMBINATION WITH DOXORUBICIN IN METASTATIC SOFT-TISSUE SARCOMA
NCT07460986 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 278
Last updated 2026-03-10
Summary
This trial will Study a type of sarcoma defined metastatic soft-tissue sarcoma (STS). Participants will be treated with bexmarilimab, a CLEVER-1 antibody plus doxorubicin, a chemotherapy. The main purpose of the Study is to analyze the safety (to find out how safe or toxic a treatment is to appropriately manage the risks) and efficacy (to find out how effective a treatment is) of bexmarilimab combined with doxorubicin in participants who have STS.
Conditions
- Sarcoma of Soft Tissue
Interventions
- DRUG
-
RP2D of bexmarilimab administered as IV infusion on D1 of 21-day cycle for 6 cycles.
- DRUG
-
Doxorubicin
75 mg/m2 doxorubicin administered as IV infusion on D1 of 21-day cycle for 6 cycles.
Sponsors & Collaborators
- collaborator INDUSTRY
-
MedSIR
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-31
- Primary Completion
- 2028-07-31
- Completion
- 2028-10-31
More Related Trials
-
Gemcitabine and Docetaxel in Combination With Pazopanib (Gem/Doce/Pzb) for the Neoadjuvant Treatment of Soft Tissue Sarcoma (STS)
NCT01418001 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
A Study of Palifosfamide Tris Plus Doxorubicin Versus Doxorubicin in Unresectable or Metastatic Soft-tissue Sarcoma
NCT00718484 ·Status: UNKNOWN ·Phase: PHASE2
-
MK-3475 in Combination With Docetaxel vs Docetaxel Alone in Non-Small Cell Lung Cancer Patients
NCT02574598 ·Status: COMPLETED ·Phase: PHASE2
-
Treatment of Metastatic Soft Tissue Sarcoma (STS) Patients (FIBROSARC USA)
NCT03420014 ·Status: RECRUITING ·Phase: PHASE2
-
Pazopanib In Patients With Relapsed Or Refractory Soft Tissue Sarcoma
NCT00297258 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase 1 Study in Participants With Advanced Cancer
NCT01115790 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Palifosfamide-tris in Combination With Doxorubicin in Patients With Front-line Metastatic Soft Tissue Sarcoma
NCT01168791 ·Status: COMPLETED ·Phase: PHASE3
-
Pembrolizumab and Doxorubicin Hydrochloride in Treating Patients With Sarcoma That is Metastatic or Cannot Be Removed by Surgery
NCT02888665 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study of Doxorubicin Plus Olaratumab (LY3012207) in Participants With Advanced or Metastatic Soft Tissue Sarcoma
NCT02451943 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of STA-4783 in Combination With Weekly Paclitaxel for Treatment of Patients With Soft Tissue Sarcomas
NCT00087997 ·Status: COMPLETED ·Phase: PHASE2
-
Dose Finding Study of L19TNF and Doxorubicin in Patients With STS
NCT04032964 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Pembrolizumab Plus Bevacizumab and Chemotherapy for Non-Squamous NSCLC Patients
NCT05751187 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Study of LY2181308 in Combination With Docetaxel Versus Docetaxel in Patients With Non-Small Cell Lung Cancer
NCT01107444 ·Status: COMPLETED ·Phase: PHASE2
-
Adebrelimab Combined With Bevacizumab and Docetaxel for Advanced Non-Squamous Non-small Cell Lung Cancer After Progression on First-line Immunotherapy
NCT06182800 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Study of Pazopanib Versus Placebo as Maintenance Therapy for Advanced Soft Tissue Sarcoma
NCT02367651 ·Status: WITHDRAWN ·Phase: PHASE2
-
Phase II Study of NGR-hTNF in Combination With Doxorubicin in Patients Affected by Soft Tissue Sarcomas.
NCT00484341 ·Status: COMPLETED ·Phase: PHASE2
-
Study of an Immunotherapeutic, DPX-Survivac, in Combination With Low Dose Cyclophosphamide & Pembrolizumab, in Subjects With Selected Advanced & Recurrent Solid Tumors
NCT03836352 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Multicenter Evaluation of Docetaxel, Gemcitabine, and Bevacizumab Combination Followed by Bevacizumab Alone in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
NCT00378573 ·Status: TERMINATED ·Phase: PHASE2
-
Study of Pembrolizumab Versus Docetaxel in Participants Previously Treated for Non-Small Cell Lung Cancer (MK-3475-033/KEYNOTE-033)
NCT02864394 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase I/II Study of Sacituzumab Govitecan Plus Berzosertib in Small Cell Lung Cancer, Extra-Pulmonary Small Cell Neuroendocrine Cancer and Homologous Recombination-Deficient Cancers Resistant to PARP Inhibitors
NCT04826341 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
NCT05920356 ·Status: RECRUITING ·Phase: PHASE3
-
Palbociclib and Pembrolizumab in Sarcoma
NCT06113809 ·Status: RECRUITING ·Phase: PHASE1
-
A Study of Safety and Efficacy of KFA115 Alone and in Combo With Pembrolizumab in Patients With Select Advanced Cancers
NCT05544929 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Trilaciclib in Combination With Docetaxel for Second-Line and Beyond Treatment of Locally Advanced or Metastatic NSCLC
NCT06929936 ·Status: RECRUITING ·Phase: PHASE2
-
Axitinib and Pembrolizumab in Subjects With Advanced Alveolar Soft Part Sarcoma and Other Soft Tissue Sarcomas
NCT02636725 ·Status: COMPLETED ·Phase: PHASE2