Rollover study of a prior clinical trial for patients with a judged favourable benefit/risk ratio for continued treatment with D-1553.

JRCT ID: jRCT2031230636

Registered date:15/02/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Advanced or metastatic solid tumors with KRASG12C mutations
• Date of first enrollment: 01/03/2024
• Target sample size: 1
• Countries of recruitment: China,Japan
• Study type: Interventional
• Intervention(s): D-1553 is administered orally daily on an empty stomach.

Outcome(s)

• Primary Outcome: SAE

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

*New patients are not being recruited for this trial as it is open to those who have participated in prior trials.
1. Patients must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible side effects) and must have signed and dated an Institutional Review Board (IRB) /Independent Ethics Committee (IEC) approved Informed Consent Form (ICF) that is in accordance with regulatory and ethics guidelines.
2. Patients must be willing and able to comply with all requirements specified in IRB approved ICF.
3. Patients must have received D-1553 treatment and benefited from the treatment per investigators assessment or have not met the end of treatment criteria in an antecedent clinical study sponsored by InventisBio.
4. Patients must have a favorable benefit/risk ratio to continue D-1553 treatment in this study, per investigators assessment.
5. Males and females of childbearing potential must agree to practice abstinence or use effective contraceptive measures from signing the ICF to 6 months after the last dose of the study drug.

Exclude criteria

1. Evidence of disease progression during screening, assessed according to the antecedent clinical study protocol that the patient was enrolled into.
2. Adverse events requiring permanent discontinuation of D-1553 in the antecedent study.
3. A treatment interruption of D-1553 for more than 21 days since the last administration of D-1553 in the antecedent study.

Related Information

• Primary Sponsor: Kitano Tina