CCH1904/MK007 trial

Phase 1

• Conditions: pediatric, adolescent and young adult patient with malignant solid tumors; Malignant solid tumors; D009369

• Registration Number: JPRN-jRCT2031190268
• Lead Sponsor: Ogawa Chitose

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-26
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1)Having a diagnosis of malignant solid tumor (but not having any hematological tumor).
2)Patients corresponding to all the followings:
(1)Having recurrent or metastatic tumor, or advanced tumor with no indication of curative surgery
(2)Standard therapy is either not available, or ineffective or intolerant
3)Not having any of the followings: pericardial fluid, pleural effusion or ascites requiring treatment.
4)Aged between 3 and 19 (Dose Escalation Part) and 3 and 29 (Extended Part) at recruitment.
5)Patients who can be orally administered.
6)Performance Status is =>50 (assessed by KPS in =>16 years patients, and LPS in <=15 years) within 14 days before registration.
7)Patients who meet either on or both of followings:
(1)Having one or more lesions of malignant solid tumor confirmed by CT or MRI, regardless of measurable or unmeasurable within 28 days before registration (Brain tumor must be confirmed by brain-enhanced MRI)
(2)Having tumor infiltration confirmed by bone-marrow examination within 28 days before registration
8)No prior treatment with EZH2 inhibitor.
9)In patients with glioma, not having new or increased doses of corticosteroids from 7 days before the day of the brain-enhanced MRI performed within 28 days before registration.
10)Not received anti-cancer drug or other study drug within 28 days before registration.
11)Not received operation under general anesthesia within 28 days before registration.
12)Not received radiation therapy within 14 days before registration.
13)Having all laboratory tests performed within 14 days before registration are the values are within the following range., Patients should not receive administration of G-CSF and/or blood transfusion within 10 days before the blood collection. Patients should not receive administration of long-acting PEGylation G-CSF (Pegfilgrastim) within 20 days before the blood collection.
(1)Neutrophil count => 1,000/mm3
(2)Platelet count => 7.5 x 104/mm3
(3)Hemoglobin => 10.0 g/dL
(4)AST <= 3 times the upper limit of clinical laboratory standards
(5)ALT <= 3 times the upper limit of clinical laboratory standards
(6)Total bilirubin <= 1.5 times the upper limit of clinical laboratory standards
(7)Creatinine <= 1.5 times the upper limit of clinical laboratory standards
14)=> 94% of SpO2 under room air conditions within 14 days before registration.
15)Consent to contraception and limited breast-feeding.
16)Written informed consent.

Exclusion Criteria

1)Active double cancer (except for completely resected basal cell carcinoma, squamous cell carcinoma, carcinoma in situ, intramucosal cancer, superficial bladder cancer, gastrointestinal cancer resected by ESD or EMR, and other cancer free of relapse for more than 5 years).
2)Not having any of the followings in patients in Dose Escalation Part: symptomatic brain tumor or brain metastasis, carcinomatous meningitis, or spinal metastasis requiring radiotherapy or surgical intervention
3)Infection requiring systemic therapy.
4)Active gastrointestinal ulceration.
5)Current or previous pneumonitis or pulmonary fibrosis diagnosed based on imaging or clinical findings (except for inactive scar or fibrosis associated with radiotherapy).
6)Current or previous severe hypersensitive reaction to medicines.
7)Having history of allogenic transplant.
8)Having history of auto transplant within 84 days before registration.
9)Body surface area <= 0.29 m2.
10)HIV antibody-positive, or HTLV-1 antibody-positive, or HBs antigen-positive, or HCV antibody-positive (those who are HCV-RNA-negative are not excluded even if HCV antibody-positive).
11)Though HBs antigen-negative, HBs antibody-positive and/or HBc antibody-positive, and HBV-DNA quantitative test positive.
12)Pregnant or breast-feeding women, or women suspected of being pregnant.
13)Psychiatric diseases or psychological symptoms interfering with participation in the trial.
14)Having any of the history (within 6 months before registration) or complications.
- Diabetes mellitus determined to be poorly controlled
- Chronic congestive heart failure (New York Heart Association: NYHA class III or higher class of cardiac function classification)
- Unstable angina, angioplasty, stent graft stenting, or myocardial infarction
- Symptomatic or arrhythmia requiring treatment or asymptomatic persistent ventricular tachycardia (except asymptomatic controllable atrial fibrillation)
15)In the 12-lead ECG within 14 days before registration, QT corrected for HR using Fridericia's method (QTcF) interval > 450 ms is observed more than twice.
16)Other conditions which the primary investigator or sub-investigator determine that the trial is inappropriate in consultation with the Clinical Trial Coordinating Office or the Trial Coordinating Committee.

Study & Design

• Study Type: Interventional
• Study Design: Not specified