Clinical trial · Interventional
A Study of IMC-A12 in Advanced Solid Tumors
A Phase 1 Study Evaluating the Safety and Pharmacokinetic Profiles of IMC-A12 Administered Every 2 Weeks or Every 3 Weeks to Japanese Patients With Advanced Solid Tumors
- 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)
In this study, participants will initially receive intravenous (IV) cixutumumab (IMC-A12) every 2 weeks or every 3 weeks for 6 weeks (one cycle). After the first cycle, participants experiencing a best overall response of complete response, partial response, or stable disease will continue to receive cixutumumab at their cohort dose and schedule until there is evidence of progressive disease (PD), or until other withdrawal criteria are met. Participants will be enrolled at one study center, located in the National Cancer Center Hospital - East, Kashiwa, Japan. Approximately 20-30 participants are anticipated.
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 |
|---|---|---|---|
| Tumors | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cixutumumab | Biological | Cixutumumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cixutumumab
- description
- Participants receive IV cixutumumab every 2 or 3 weeks. A cycle equals 6 weeks, with radiological evaluation of tumor response after each cycle. After 1st cycle, pts with a complete response (CR), PR, or SD continue to receive cixutumumab cohort dose and schedule disease progression. 3 pts enroll in each cohort. Starting dose in Cohort 1 is 6 mg/kg every 2 weeks. Dose escalation from Cohort 1 to Cohort 2 (10 mg/kg every 2 weeks) occurs at least 3 pts in Cohort 1 completes 1 cycle of therapy. Enrollment into Cohort 3 (starting dose: 15 mg/kg administered every 3 weeks) will not proceed until at least 3 pts have completed one cycle of therapy in Cohort 2. Pts enroll in Cohort 4 once at least 3 pts have completed once cycle of therapy in Cohort 3; pts in Cohort 4 receive 20 mg/kg every 3 weeks.
- interventionNames
- Biological: Cixutumumab
Primary outcomes (7)
- measure
- Summary Listing of Percentage of Participants Reporting Treatment-Emergent Adverse Events
- timeFrame
- Up To 63 Months
- description
- A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Solid tumor participant who has been histopathologically or cytologically documented * Advanced primary or recurrent solid tumor participant who has not responded to standard therapy or for whom no standard therapy is available * The participant has measurable or nonmeasurable lesions according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0) guidelines * The participant has an Eastern Cooperative Oncology Group performance status (ECOG PS)score of 0-1 at study entry * The participant is able to provide 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/m3 or /μL * A hemoglobin ≥ 10 g/dL; and * A platelet count ≥ 100,000/mm3 or /μL * The participant has adequate hepatic function, as defined by: * Total bilirubin ≤ 1.8 mg/dL * Aspartate transaminase (AST) ≤ 2.5 times the upper limit of site-specific normal ranges (five times in case of liver metastasis) * Alanine transaminase (ALT) ≤ 2.5 times the upper limit of site-specific normal ranges (five times in case of liver metastasis) * The participant has adequate renal function, as defined by: * Serum creatinine ≤ 1.5 mg/dL * Calculated serum creatinine clearance (Cockcroft-Gault) ≥ 60 mL/min * The participant has fasting blood sugar \< 120 mg/dL or below the institutional upper limit of normal (ULN) before study entry (one retest of an elevated level is permitted at the discretion of the investigator) * The participant has adequate coagulation function, as defined by an international normalized ratio (INR) ¬ 1.5 * The participant agrees to use adequate contraception for the duration of study participation and for 12 weeks after the last dose of study therapy. * The participant has adequate recovery from recent surgery, chemotherapy, and radiation therapy (including palliative radiation therapy). At least 28 days (6 weeks for nitrosoureas or mitomycin C) must have elapsed from major surgery, prior chemotherapy, prior treatment with an investigational agent or device, or prior radiation therapy. For treatment with unapproved monoclonal antibodies, a minimum of 8 weeks must have elapsed * The participant is willing to comply with study procedures until the end of therapy Exclusion Criteria: * The participant has received chemotherapy or therapeutic radiotherapy within 28 days (6 weeks for nitrosoureas or mitomycin C) prior to entering the study, or the participant has ongoing side effects ≥ Grade 2 due to agents administered more than 28 days earlier * The participant has undergone major surgery (eg,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 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 the 4 weeks prior to enrollment) with an assessment that no further treatment (radiation, surgical excision, or administration of steroids) is required are permitted to enter the study) * The participant has an uncontrolled intercurrent illness including, but not limited to: * Thrombotic or hemorrhagic disorders * Gross hemoptysis (approximately one-half a teaspoon) * Ongoing or active infection requiring systemic antibiotic treatment * Congestive heart failure (Class III or IV per 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 mm Hg, diastolic blood pressure \> 95 mm Hg) * Cardiac arrhythmia requiring treatment (NCICTCAE Version 3.0 Grade 3), or asymptomatic sustained ventricular tachycardia * Peripheral neuropathy of any etiology ≥ Grade 2 (NCI-CTCAE Version 3.0); or * Any other serious uncontrolled medical disorder(s) in the opinion of the investigator * The participant has a serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to study entry * The participant has experienced any Grade 3/4 gastrointestinal bleeding within 3 months prior to study entry * The participant has participated in clinical studies of unapproved experimental agents or procedures within 4 weeks prior to study entry for small molecules, or 8 weeks prior to study entry for unapproved monoclonal antibodies * The participant has received any previous treatment with agents targeting the insulin-like growth factor hormone (IGF-IR), approved or unapproved * The participant has a known allergy to any of the treatment components (monoclonal antibodies or other therapeutic proteins such as fresh frozen plasma, human serum albumin, cytokines, or interleukins). In the event that there is suspicion the participant may have allergies, the participant should be excluded * The participant, if female, is pregnant (confirmed by urine or serum pregnancy test) or lactating * The participant has a known alcohol or drug dependency * The participant is Hepatitis B Virus (HBV) antigen-, Hepatitis C Virus (HCV) antibody-, or HIV antibody-positive (asymptomatic healthy carriers with detectable HBV-DNA, HCV-RNA may be enrolled into the trial) * The participant is assessed as inadequate for the study by the investigator
References
Publications (1)
- DERIVEDDoi T, Shitara K, Kojima T, Yoshino T, Dontabhaktuni A, Rebscher H, Tang S, Cosaert J, Ohtsu A. A phase I study evaluating cixutumumab, a type 1 insulin-like growth factor receptor inhibitor, given every 2 or 3 weeks in Japanese patients with advanced solid tumors. Cancer Chemother Pharmacol. 2016 Jun;77(6):1253-62. doi: 10.1007/s00280-016-3041-7. Epub 2016 Apr 30. PMID 27139036