Clinical trial · Interventional
A Phase 1, Dose Finding Study of CC-90002 in Subjects With Advanced Solid and Hematologic Cancers
A Phase I, Open-Label, Dose Finding Study of CC-90002, a Monoclonal Antibody Directed Against CD47, in Subjects With Advanced Solid and Hematologic Cancers
NCT02367196CI-TRIAL-00053231completedPhase 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)
CC-90002-ST -001 is an open-label, Phase 1, dose escalation clinical study in subjects with advanced, refractory solid and hematologic cancers.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Neoplasms | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CC-90002 | Drug | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part A: CC-90002
- description
- CC-90002 will be given by intravenous (IV) infusion on a 28 day cycle
- interventionNames
- Drug: CC-90002
- type
- EXPERIMENTAL
- label
- Part B: CC-90002 with Rituximab
- description
- CC-90002 in combination with Rituximab will be given by intravenous (IV) infusion on a 28 day cycle in subjects with CD20-positive NHL
- interventionNames
- Drug: CC-90002
- Drug: Rituximab
Primary outcomes (5)
- measure
- Dose-Limiting Toxicity (DLT)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Men and women, 18 years or older, with advanced, relapsed or refractory solid tumors, Multiple Myeloma (MM) or non-Hodgkin's lymphoma (NHL) in Part A. In Part B, relapsed and/or refractory CD20-positive NHL subjects only. 2. At least one site of measurable disease in subjects with solid tumors and NHL. 3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. 4. Subjects must have adequate hematopoietic, liver, renal and coagulation function as assessed by specific laboratory criteria. 5. Females and males must agree to contraceptive methods and avoid conceiving throughout the study, and for up to 8 weeks following the last dose of CC-90002. If participating in Part B, females of child bearing potential should continue to use effective contraceptive methods for 12 months following treatment with rituximab Exclusion Criteria: 1. High grade lymphomas (Burkitts or lymphoblastic), plasma cell leukemia. 2. High grade, rapidly proliferative solid tumors (eg, small cell lung cancer, germ cell tumors, neuroblastoma) with extensive tumor burden. 3. Symptomatic central nervous system involvement. 4. Impaired cardiac function or clinically significant cardiac disease. 5. Prior Red blood cell (RBC) transfusion \< 3 months prior to starting CC-90002 (Part A only). 6. Prior autologous stem cell transplant ≤ 3 months prior to starting CC-90002. 7. Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 6 months prior to starting CC-90002. 8. Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half lives or 4 weeks prior to starting CC-90002, whichever is shorter. 9. Major surgery ≤ 2 weeks prior to starting CC-90002. 10. Pregnant or nursing females. 11. Known HIV infection. 12. Known chronic, active hepatitis B or C (HBV/HCV) infection. 13. Ongoing treatment with chronic, therapeutic dosing of anti-coagulants. 14. History of autoimmune hemolytic anemia or autoimmune thrombocytopenia. 15. History of concurrent second cancers requiring active, ongoing systemic treatment. concurrent second cancers requiring active, ongoing systemic treatment.
References
Publications (1)
- DERIVEDNarla RK, Modi H, Bauer D, Abbasian M, Leisten J, Piccotti JR, Kopytek S, Eckelman BP, Deveraux Q, Timmer J, Zhu D, Wong L, Escoubet L, Raymon HK, Hariharan K. Modulation of CD47-SIRPalpha innate immune checkpoint axis with Fc-function detuned anti-CD47 therapeutic antibody. Cancer Immunol Immunother. 2022 Feb;71(2):473-489. doi: 10.1007/s00262-021-03010-6. Epub 2021 Jul 10. PMID 34247273