Clinical trial · Interventional
A Study of IMC-CS4 in Subjects With Advanced Solid Tumors
Phase 1 Study of IMC-CS4, a Monoclonal Antibody Targeted to the CSF-1 Receptor (CSF-1R), In Subjects With Advanced Solid Tumors Refractory to Standard Therapy or for Which No Standard Therapy is Available
NCT01346358CI-TRIAL-00080682completedPhase 1Results postedClinicalTrials.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)
A dose escalation study to establish the safety profile and characterize the pharmacokinetic profile of IMC-CS4 in the treatment of subjects with advanced solid tumors refractory to standard therapy or for which no standard therapy is available.
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 |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IMC-CS4 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- IMC-CS4 Weight Based Dosing
- description
- Participants received 2.5 mg/kg once weekly (QW), 0.3 mg/kg QW, 0.6 mg/kg QW, 1.25 mg/kg every two weeks (Q2W) and1.25 mg/kg QW of IMC CS4 by intravenous infusion in Part A.
- interventionNames
- Biological: IMC-CS4
- type
- EXPERIMENTAL
- label
- IMC-CS4 Non-Weight Based Dosing
- description
- Participants received 100 mg QW, 100 mg QW on weeks 1, 2, 4 and 5 and 150 mg QW of IMC CS4 by intravenous infusion in Part B.
- interventionNames
- Biological: IMC-CS4
Primary outcomes (5)
- measure
- Pharmacokinetics (PK) - Maximum Concentration (Cmax) of IMC-CS4
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subject has histologic or cytologic confirmation of advanced solid tumors that is refractory to standard therapy or for which no standard therapy is available * Subject has measurable or nonmeasurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 * Subject has resolution to grade ≤1 by NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) Version 4.03 of all clinically significant toxic effects of prior treatment * Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Subject has adequate hematologic, hepatic, renal, and coagulation function * Subject has a life expectancy greater than 3 months * Subject agrees to use adequate contraception during the study period and for 12 weeks after last dose of study therapy * Subject must undergo mandatory biopsies, including one pretreatment and one post treatment tumor biopsy procedure Exclusion Criteria: * Subject has experienced acute pathologic fracture or spinal cord compression within 28 days prior to first dose of study therapy * Subject has a known hypersensitivity to monoclonal antibodies or to agents of similar biologic composition as IMC-CS4. * Subject has received treatment with any monoclonal antibodies within 4 weeks prior to first dose of study therapy * Subject has undergone a major surgical procedure, open biopsy, radiofrequency ablation or has experienced a significant injury within 28 days prior to enrollment * Subject has a concurrent active malignancy other than adequately treated nonmelanomatous skin cancer or in situ neoplasm * Subject has an ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, active bleeding or any other serious uncontrolled medical disorder * Subject has known or suspected primary brain or leptomeningeal metastases * Subject has leukemia or lymphoma * Subject is know to have active tuberculosis, leishmaniasis, or listeriosis * Subjects with known history, or clinical or laboratory evidence of liver disease * Subject has a known active hepatitis B or C infection, Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) * Subject if female, is pregnant or breastfeeding * Subject has received an organ transplant
References
Publications (1)
- DERIVEDDowlati A, Harvey RD, Carvajal RD, Hamid O, Klempner SJ, Kauh JSW, Peterson DA, Yu D, Chapman SC, Szpurka AM, Carlsen M, Quinlan T, Wesolowski R. LY3022855, an anti-colony stimulating factor-1 receptor (CSF-1R) monoclonal antibody, in patients with advanced solid tumors refractory to standard therapy: phase 1 dose-escalation trial. Invest New Drugs. 2021 Aug;39(4):1057-1071. doi: 10.1007/s10637-021-01084-8. Epub 2021 Feb 23. PMID 33624233