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A Phase 1 study of RN-1101 in patients with solid tumor

A Phase 1 study of RN-1101

Matsumura Yasuhiro

RIN Institute Inc.

1-13-10-2F Tsukiji, Chuo-ku, Tokyo

info@rinmab.co.jp

Matsumura Yasuhiro

RIN Institute Inc.

1-13-10-2F Tsukiji, Chuo-ku, Tokyo

+81-70-1255-5664

info@rinmab.co.jp

Suspended

Jan. 31, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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

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

Both

Dose-escalation cohort:Solid tumors
Expansion cohort 1:Colorectal cancer
Expansion cohort 2:TMEM1

RN-1101 will be administrated weekly until disease progression, unacceptable treatment-related toxicity, withdrawal of consent or discontinuation for any reason, whichever occurs first.

DLT

1. Safety
2. Efficacy
3. Pharmacokinetics

Dec. 28, 2022

none