Clinical trial · Interventional
A Study of CC-122 to Assess the Safety and Tolerability in Japanese Patients With Advanced Solid Tumors and Non-Hodgkin's Lymphoma (NHL)
A Phase 1, Multi-center, Open-label Dose-escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of CC-122 Administered Orally to Adult Japanese Subjects With Advanced Solid Tumors or Non-Hodgkin's Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Replaced it with another clinical trial.
Summary
Brief summary (as posted)
To determine the safety and tolerability of CC-122 when administered orally to adult Japanese subjects with advanced solid tumors or Non-Hodgkin's Lymphoma (NHL) and to define the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).
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 |
|---|---|---|---|
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CC-122 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CC-122
- description
- CC-122 is administered orally, on a 5 continuous days out of 7 days per week intermittent dosing schedule.
- interventionNames
- Drug: CC-122
Primary outcomes (11)
- measure
- Number of Participants With Dose-Limiting Toxicities (DLTs)
- timeFrame
- From first dose up to at least 28 days (Cycle 1)
- description
- NCI CTCAE Version 4.03 will be used to grade adverse events. Events described below will be classified as DLTs: * Non-hematologic AEs: Suspected to be related to CC-122, commences during the DLT evaluation period, and is ≥ Grade 3 * Laboratory abnormalities: Suspected to be related to CC-122, commences during the DLT evaluation period, and is ≥ Grade 3 * Hematologic: Any febrile neutropenia, Grade 4 neutropenia lasting \> 7 days, Grade 4 thrombocytopenia lasting \> 24 hours or thrombocytopenia of any grade requiring platelet transfusions, Any Grade 3/4 thrombocytopenia with clinically significant bleeding * Hepatic: Grade 4 liver function tests or Grade 3 ALT with Grade 2 or higher bilirubin will be considered a DLT, irrespective of underlying attribution. Other Grade 3 LFTs due to disease progression in the liver will not be considered DLTs * Other adverse events: Suspected to be related to CC-122 and necessitating a dose reduction during the DLT evaluation period
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria:
1. Understand and voluntarily sign an informed consent document prior to any study-related assessments/procedures are conducted
2. 20 years or older, with histological or cytological confirmation of advanced solid tumors or Non-Hodgkin's Lymphoma (NHL), including those who have progressed on standard anticancer therapy or for whom no other conventional therapy exists
3. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2 for all tumors
4. Subjects must have the following laboratory values:
・Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
* Hemoglobin (Hgb) ≥ 9 g/dL, drawn at least 7 days after the last RBC transfusion
* Platelets (Plt) ≥ 100 x 109/L, drawn at least 7 days after the last platelet transfusion
* Potassium within normal limits or correctable with supplements
* Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 3 x upper limit of normal (ULN) or ≤ 5.0 x ULN if liver tumors are present
* Serum bilirubin ≤ 1.5 x ULN; subjects with serum bilirubin \>1.5 x ULN and ≤ 2 x ULN may be enrolled if agreed to by the sponsor
* Serum creatinine ≤ ULN or 24-hour clearance ≥ 50 mL/min
* Negative serum pregnancy test in females of childbearing potential as per the CC-122 Pregnancy Prevention Rist Management Plan
5. Able to adhere to the study visit schedule and other protocol requirements
6. Must adhere to the Pregnancy Prevention Rist Management Plan
Exclusion Criteria:
1. Subjects with primary central nervous system (CNS) malignancies or symptomatic central nervous system metastases. Subjects with brain metastases that have been previously treated and are stable for 6 weeks are allowed
2. Known acute or chronic pancreatitis
3. Any peripheral neuropathy ≥ NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) Grade 2
4. Persistent diarrhea or malabsorption ≥ NCI CTCAE Grade 2, despite medical management
5. Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
* Left Ventricular Ejection Fraction (LVEF) \< 45% as determined by Multiple Gated Acquisition Scan (MUGA) scan or Echocardiogram (ECHO)
* Complete left bundle branch, or bifascicular block
* Congenital long QT syndrome
* Persistent or uncontrolled ventricular arrhythmias or atrial fibrillation
* QTcF \> 460 msec on screening electrocardiogram (ECG) (mean of triplicate recordings)
* Unstable angina pectoris or myocardial infarction ≤ 3 months prior to starting CC-122
* Troponin-T value \>0.4 ng/mL or Brain Natriuretic Peptide (BNP) \>300 pg/mL Subjects with baseline troponin-T \>ULN or BNP \>100 pg/mL are eligible but must and optimization of cardioprotective therapy.
* Other clinically significant heart disease such as congestive heart failure requiring treatment or uncontrolled hypertension (blood pressure ≥ 160/95 mmHg)
6. Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half lives or 4 weeks, whichever is shorter, prior to starting CC-122 or who have not recovered from side effects of such therapy. Luteinizing hormone-releasing hormone (LHRH) agonists will be allowed for subjects with metastatic prostate cancer
7. Major surgery ≤ 2 weeks prior to starting CC-122 or still recovering from post operative side effects
8. Women who are pregnant or breast feeding. Adults of reproductive potential not employing two forms of birth control as per Pregnancy Prevention Risk Management Plan (PPRMP)
9. Known human immunodeficiency virus (HIV) infection
10. Known acute or chronic hepatitis B or C virus infection
11. Status post solid organ transplant
12. Less than 100 days for subjects receiving autologous hematologic stem cell transplant (HSCT); or 6 months for subjects receiving allogeneic HSCT, or if otherwise not fully recovered from HSCT-related toxicity
a. The 6-month exclusionary period for recovery from HSCT-associated toxicity, applies regardless of whether an autologous or allogeneic transplant was performed
13. Known hypersensitivity to any component of the formulation of CC-122
14. Any significant medical condition (including active or controlled infection or renal disease), laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
15. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
16. Any condition that confounds the ability to interpret data from the studyReferences
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