RNK05047: RNK05047 is a chaperone-mediated protein degrader administered as IV infusion once weekly for 3 consecutive weeks in a 4-week cycle (no treatment in the fourth week).
Study summary
This is a first in human, Phase 1/2 open-label multi-center, dose escalation and expansion study to evaluate the safety, tolerability, PK, PD and efficacy of RNK05047 when administered an intravenous (IV) infusion to subjects with advanced solid tumors, including diffuse large B-cell lymphoma (DLBCL).
This is a 2-part study (dose escalation, cohort expansion) with sequential enrollment.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Pathologically documented locally advanced or metastatic solid tumor
* Refractory or intolerant to all available standard-of-care therapies for advanced disease
* Measurable disease
* Archived tumor tissue collected
* ECOG Performance Status of 0 or 1
* BMI ≥ 18 kg/m2
* Adequate liver, renal, hematologic, and coagulation parameters
* Negative serum pregnancy test (for women of childbearing potential) at Screening and a negative urine or serum pregnancy test on Day 1 prior to the first infusion
* Males and females of childbearing potential must agree to use a highly effective method of contraception during treatment and for at least 4 months after the last dose of study treatment.
* Must be able to understand and comply with the conditions of the protocol and must have read and understood the consent form and provided written informed consent.
Exclusion Criteria:
* Concurrent anticancer therapy: Radiotherapy, chemotherapy, biological therapy, or other anticancer investigational agents NOTE: at least 5 half-lives must have been ensued for any prior systemic cancer therapy agent before subject received the study drug on Day 1
* Unresolved toxicities from prior anticancer therapy, defined as not having resolved according to CTCAE version 5.0 Grade ≤ 1, excluding Grade 1 alopecia
* Presence or suspicion of active central nervous system (CNS) metastases and/or leptomeningeal carcinomatosis
* Peripheral neurotoxicity ≥ Grade 2 according to CTCAE v5.0
* Known active infection with HIV, HTLV-1, hepatitis B or C
* Women who are pregnant or breastfeeding
* History of another malignancy unless the subject has been treated with curative intent for this malignancy
Primary outcome measure(s)
Part 1: Incidence of DLTs — through 1 cycle/4 weeks
Part 1: Incidence of TEAEs — through study completion, an average of 1 year
Part 2: Incidence of TEAEs — through study completion, an average of 1 year
Part 2: Objective response rate (ORR) based on RECIST 1.1/RECIL 2017 — through study completion, an average of 1 year
Part 2: Duration of response (DoR) based on RECIST 1.1/RECIL 2017 — through study completion, an average of 1 year
Part 2: Progression-free Survival (PFS) based on RECIST 1.1/RECIL 2017 — through study completion, an average of 1 year
Part 2: Disease Control Rate (DCR) based on RECIST 1.1/RECIL 2017 — through study completion, an average of 1 year
Trial sites (5)
Facility
City
Region
Status
Emory University Winship Cancer Institute
Atlanta
Georgia
Completed
Norton Cancer Institute
Louisville
Kentucky
Completed
Weill Cornell - NY Presbyterian Hospital
New York
New York
Completed
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing
Beijing Municipality
Recruiting
Beijing Cancer Hospital
Beijing
Beijing Municipality
Recruiting
More Ranok Therapeutics (Hangzhou) Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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