Clinical trial · Interventional
Study of IMC-1121B in Patients With Advanced Solid Tumors
Phase 1 Study of IMC-1121B in Patients With Advanced Solid Tumors
NCT01005355CI-TRIAL-00014869completedPhase 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)
This trial is testing the investigational drug IMC-1121B administered to Japanese participants with advanced solid tumors who have not responded to standard therapy or for whom no standard therapy is available. The rationale for performing this trial is to establish the safety profile and the pharmacokinetics of IMC-1121B.
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 |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IMC-1121B | Biological | Ramucirumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IMC-1121B
- description
- Participants receiving IMC-1121B intravenously
- interventionNames
- Biological: IMC-1121B
Primary outcomes (17)
- measure
- Number of Participants With Drug-Related Adverse Events
- timeFrame
- Baseline to study completion up to 48 weeks
- description
- Data presented are the number of participants who experienced adverse events (AE) of any grade, AE of Grade ≥3 based on National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0 (NCI-CTCAE v 3.0), serious adverse events (SAE) and AE resulting in death that was considered to be related to IMC-1121B (ramucirumab). A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.
- measure
- IMC-1121B Pharmacokinetics: Maximum Serum Concentration (Cmax) - Cohorts 1 and 2 During Cycles 1 and 2
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Solid tumor participant who was been histopathologically or cytologically documented. * Advanced primary or recurrent solid tumors participant who has not responded to standard therapy or no standard therapy is available. * The participant has measurable or nonmeasurable lesions according to Response Evaluation Criteria in Solid Tumors (RECIST). * The participant has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1 at study entry. * The participant is able to provide written informed consent. * The participant is age 20 years or older. * The participant has a life expectancy of \> 3 months. * The participant has adequate hematologic function, as defined by: * An absolute neutrophil count (ANC) \> 1500/cubic millimeter (mm³) or /microliter (µL) * A hemoglobin level \> 10 grams/deciliter (g/dL) * A platelet count \> 100,000/mm³ or /µL * The participant has adequate hepatic function, as defined by: * A total bilirubin level \< 1.8 milligrams/deciliter (mg/dL) * Aspartate transaminase (AST) levels \< 86 International Units/liter (IU/L) * Alanine transaminase (ALT) levels ≤ 86 IU/L * The participant has adequate renal function, as defined by: * Serum creatinine level ≤ 1.5 mg/dL, or * Calculated serum creatinine clearance (Cockcroft-Gault) ≥ 60 milliliters/minute (mL/min) * The participant's urinary protein is 0 on dipstick or 1+ but participant does not have edema nor serum albumin \< lower level of normal (LLN). * The participant has adequate coagulation function, as defined by international normalized ratio (INR) ≤ 1.5. * The participant agrees to use adequate contraception during the study period and for 12 weeks after the last dose of study treatment. Exclusion Criteria: * The participant has had chemotherapy or therapeutic radiotherapy within 28 days (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or participant has ongoing side effects ≥ Grade 2 due to agents administered more than 28 days earlier. * The participant has obvious evidence of intratumor cavitation. * The participant has undergone major surgery (example, laparotomy, thoracotomy, removal of organ\[s\]) within 28 days prior to study entry, or subcutaneous venous access device placement within 7 days prior to study entry. * The participant has a history of postoperative bleeding complications or wound complications from a surgical procedure. * The participant has elective or planned surgery to be conducted during the trial. * The participant has documented and/or symptomatic brain or leptomeningeal metastases. (Participants who are clinically stable \[no symptoms during 4 weeks prior to the enrollment\] with an assessment that no further treatment \[radiation, surgical excision, and administration of steroids\] is required, are permitted to enter the study.) * The participant has uncontrolled intercurrent illness including, but not limited to: * Thrombotic or hemorrhagic disorders * Hemoptysis (approximately one-half of a teaspoon) * Ongoing or active infection requiring systemic antibiotic treatment * Congestive heart failure (Class III or IV of the New York Heart Association classification for heart disease) * Angina pectoris, angioplasty, stenting, or myocardial infarction within 6 months * Uncontrolled hypertension (systolic blood pressure \> 150 millimeters of mercury (mmHg), diastolic blood pressure \> 95 mm Hg) * Cardiac arrhythmia requires treatment \[National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0 (NCI-CTCAE v 3.0), Grade 3\], or asymptomatic sustained ventricular tachycardia) * Peripheral neuropathy of any etiology ≥ Grade 2 (NCI-CTCAE v 3.0) * The participant has participated in clinical studies of non-approved experimental agents or procedures within 4 weeks prior to study entry for small molecules, or 8 weeks prior to study entry for non-approved monoclonal antibodies. * The participant, if female, is pregnant (confirmed by urine or serum pregnancy test) or lactating.
References
Publications (1)
- DERIVEDNokihara H, Yamamoto N, Yamada Y, Honda K, Asahina H, Tamura Y, Hozak RR, Gao L, Suzukawa K, Enatsu S, Tamura T. A phase 1 study of ramucirumab in Japanese patients with advanced solid tumors. Jpn J Clin Oncol. 2017 Apr 1;47(4):298-305. doi: 10.1093/jjco/hyx008. PMID 28158463