A Phase 1 study of RN-1101

JRCT ID: jRCT2031220477

Registered date:30/11/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Solid tumor
• Date of first enrollment: 16/01/2023
• Target sample size: 88
• Study type: Interventional
• Intervention(s): RN-1101 will be administrated weekly until disease progression, unacceptable treatment-related toxicity, withdrawal of consent or discontinuation for any reason, whichever occurs first.

Outcome(s)

• Primary Outcome: DLT

Secondary Outcome

1. Safety
2. Efficacy
3. Pharmacokinetics

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Cytologically- or histologically-confirmed diagnosis of a locally advanced or metastatic solid tumor
2. Refractory to or intolerable with standard treatment, or for which no standard treatment is available
3. Age 18 years or older
4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1
5. Willing and able to provide informed consent
6. Mesureable disease per RECIST version 1.1

Exclude criteria

1. Has multiple primary malignancies within 2 years
2. Has clinically active brain metastases
3. Has a history of Interstitial pneumonia
4. Known HIV infection
5. Known ative hapatitis B or C infection
6. Is pregnant as confirmed or possible, or a lactating mother

Related Information

• Primary Sponsor: Yoshimatsu Kentaro