Clinical trial · Interventional
Study of TJ011133 in Participants With Relapsed/Refractory Advanced Solid Tumors and Lymphoma
A Phase 1 Study of TJ011133 Administered Alone or in Combination With Pembrolizumab or Rituximab in Subjects With Relapsed/Refractory Advanced Solid Tumors and Lymphoma
NCT03934814CI-TRIAL-00078423completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to assess the safety and tolerability of TJ011133 in participants with solid tumors and lymphoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
| TJ011133 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Part 1A - TJ011133 Monotherapy
- description
- TJ011133 alone will be administered at up to 7 dose levels (0.3, 1, 3, 10, 20, 30, 45 mg/kg) once weekly (Q1W) (the 0.3 mg/kg dose level cohort will be enrolled if a DLT in 1 out of 3 subjects is observed following the 1 mg/kg dose level).
- interventionNames
- Drug: TJ011133
- type
- EXPERIMENTAL
- label
- Part 1B - Combination therapy of TJ011133 with pembrolizumab
- description
- TJ011133 will be administered Q1W, starting at 20 mg/ kg, in combination with pembrolizumab.
- interventionNames
- Drug: TJ011133
- Drug: Pembrolizumab
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Part 1: Participants with advanced relapsed/refractory solid tumors and lymphoma. * Part 2 with Rituximab: Participants with diffuse large B-cell lymphoma (DLBCL) or Indolent B-cell Lymphoma, with at least one measurable lesion by Lugano and available fresh metastatic biopsy sample prior to study entry. * Part 2 with Pembrolizumab: Participants with locally advanced non-small-cell lung carcinoma (NSCLC) with disease progression or immune-oncology treatment naive Epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer, with at least one measurable lesion defined by Response Elevation Criteria in Solid Tumors (RECIST) 1.1, and available fresh metastatic biopsy prior to study entry. * All Parts: Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1 and adequate bone marrow, renal, and liver functions. Exclusion Criteria: * Participants with known symptomatic central nervous system tumors or known central nervous system metastases or leptomeningeal disease requiring steroids. Participants who document stable and central nervous system metastases and are off steroids for more than 4 weeks may be enrolled in the study. * Participants with Burkitt's lymphoma, lymphoblastic lymphoma, Richter's transformation, primary effusion lymphoma or chronic lymphocytic leukemia/small lymphocytic lymphoma. * Participants with mantle cell lymphoma. * Impaired cardiac function or clinically significant cardiac diseases. * Prior treatment with CD47 or SIRPα inhibitors. * Prior autologous stem cell transplant \<=3 months prior to starting study. * Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning. * Prior chimeric antigen receptor or chimeric antigen receptor T-cell therapy. * History of autoimmune anemia or autoimmune thrombocytopenia. * Positive Direct Antiglobulin Test. * Active graft versus host disease (GVHD) or ongoing immunosuppression for GVHD.
References
Publications (0)
Data not yet available
No reference posted for this study.