Dose-escalation cohort:Solid tumors Expansion cohort 1:Colorectal cancer Expansion cohort 2:TMEM1
Conditions
Interventions
RN-1101 will be administrated weekly until disease progression, unacceptable treatment-related toxicity, withdrawal of consent or discontinuation for any reason, whichever occurs first.
Sponsors
Matsumura Yasuhiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Cytologically- or histologically-confirmed diagnosis of a locally advanced or metastatic solid tumor (In the expansion cohort, it is limited to colon or rectal cancer.) 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DLT | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety 2. Efficacy 3. Pharmacokinetics | — |
Contacts
Public ContactYasuhiro Matsumura
RIN Institute Inc.
Outcome results
None listed