BOXR1030 T Cells in Subjects With Advanced GPC3-Positive Solid Tumors
NCT05120271 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 7
Last updated 2025-12-05
Summary
This is a first-in-human (FIH), Phase 1/2, open-label, multicenter study to assess safety and determine the recommended Phase 2 dose (RP2D) of BOXR1030 administration after lymphodepleting chemotherapy (LD chemotherapy) in subjects with glypican-3 positive (GPC3+) advanced solid tumors.
Conditions
- Hepatocellular Carcinoma
- Squamous Cell Carcinoma of the Lung
- Merkel Cell Carcinoma
- Myxoid/Round Cell Liposarcoma
Interventions
- BIOLOGICAL
-
CAR-GPC3 T Cells
Five dose levels each with LD chemotherapy
Sponsors & Collaborators
-
SOTIO Biotech a.s.
collaborator INDUSTRY -
SOTIO Biotech AG
collaborator INDUSTRY -
Sotio Biotech Inc.
lead INDUSTRY
Principal Investigators
-
Pauline Duhard, Pharm.D. · SOTIO Biotech AG
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-10-26
- Primary Completion
- 2025-10-24
- Completion
- 2042-12-31
- FDA Drug
- Yes
Countries
- United States
- United Kingdom
Study Locations
More Related Trials
-
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
NCT05239143 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
HLX301 (TIGIT×PDL1 Bispecific) in Patients With Locally Advanced or Metastatic Solid Tumors
NCT05102214 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
A Study of GC203 TIL in Advanced Malignant Solid Tumors
NCT06375187 ·Status: RECRUITING ·Phase: PHASE1
-
Pembrolizumab in Treating Patients With Rare Tumors That Cannot Be Removed by Surgery or Are Metastatic
NCT02721732 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Gene Modified Immune Cells After Conditioning Regimen for the Treatment of Stage IIIC or IV Melanoma or Metastatic Solid Tumors
NCT04119024 ·Status: RECRUITING ·Phase: PHASE1
-
A Study With ABL103 in Subjects With Advanced or Metastatic Solid Tumors
NCT06126666 ·Status: RECRUITING ·Phase: PHASE1
-
Cytokine Armored GPC3 Specific Chimeric Antigen Receptor Expressing T-cells in Adults With Solid Tumors
NCT07224568 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
Study of INBRX-105 and INBRX-105 With Pembrolizumab in Patients With Solid Tumors Including Head and Neck Cancer
NCT03809624 ·Status: TERMINATED ·Phase: PHASE1
-
Multi-center Phase I/IIa Trial of an Autologous Tumor Lysate (TL) + Yeast Cell Wall Particles (YCWP) + Dendritic Cells (DC) Vaccine in Addition to Standard of Care Checkpoint Inhibitor of Choice in Metastatic Melanoma Patients With Measurable Disease.
NCT02678741 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study of Atezolizumab Administered in Combination With Bevacizumab and/or With Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors
NCT01633970 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of IMC-002 in Subjects With Metastatic or Locally Advanced Solid Tumors and Relapsed or Refractory Lymphomas
NCT04306224 ·Status: COMPLETED ·Phase: PHASE1
-
A Dose Escalation, Dose Expansion Study to Evaluate the Safety, Tolerability, and Antitumor Activity of MEDI-575, in Subjects With Advanced Tumors.
NCT00816400 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase I Study of GC101 TIL in Advanced Solid Tumors
NCT05417750 ·Status: COMPLETED ·Phase: PHASE1
-
A Vaccine (CDX-1401) With or Without a Biologic Drug (CDX-301) for the Treatment of Patients With Stage IIB-IV Melanoma
NCT02129075 ·Status: COMPLETED ·Phase: PHASE2
-
Treatment of Relapsed and/or Chemotherapy Refractory Advanced Malignancies by CART-meso
NCT02580747 ·Status: UNKNOWN ·Phase: PHASE1
-
A Phase 1 Study of INCMGA00012 in Patients With Advanced Solid Tumors
NCT03059823 ·Status: COMPLETED ·Phase: PHASE1
-
First-in-human Study of BAY2287411 Injection, a Thorium-227 Labeled Antibody-chelator Conjugate, in Patients With Tumors Known to Express Mesothelin
NCT03507452 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 1 Study of BGB-B2033, Alone or in Combination With Tislelizumab With or Without Bevacizumab, in Participants With Advanced or Metastatic Solid Tumors
NCT06427941 ·Status: RECRUITING ·Phase: PHASE1
-
Immunization With a Pentavalent Vaccine Composed of KLH-conjugates of GD2L, GD3L, Globo H, Fucosyl GM1, and N-Propionylated Polysialic Acid
NCT01349647 ·Status: COMPLETED ·Phase: PHASE1
-
A Clinical Trial Evaluating IL-22BP/LNP Compound in Refractory Malignant Solid Tumors for Safety, Tolerability and Activity
NCT07100210 ·Status: RECRUITING ·Phase: PHASE1
-
A Study of SPX-303, a Bispecific Antibody Targeting LILRB2 and PD-L1 in Patients With Solid Tumors
NCT06259552 ·Status: RECRUITING ·Phase: PHASE1
-
GEN1047 for Solid Tumors - First in Human (FIH) Trial
NCT05180474 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Study to Evaluate Safety, PK, PD, Immunogenicity & Antitumor Activity of MSC-1 in Patients With Adv Solid Tumors
NCT03490669 ·Status: COMPLETED ·Phase: PHASE1
-
Study of IMC-3G3 in Patients With Tumors That Are Not Responding to Standard Therapies or No Therapy is Available
NCT00768391 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 1 Study of JMT108 in Participants With Advanced Solid Tumors
NCT07317505 ·Status: RECRUITING ·Phase: PHASE1