A Study of RNK05047 in Subjects With Advanced Solid Tumors/Diffuse Large B-cell Lymphoma (CHAMP-1)
- Registration Number
- NCT05487170
- Lead Sponsor
- Ranok Therapeutics (Hangzhou) Co., Ltd.
- Brief 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.
- Detailed Description
In Part 1, enrolled subjects will receive IV RNK05047 once weekly for 3 consecutive weeks in a 4-week cycle (no treatment in the fourth week). The dose-escalation phase will follow a standard 3+3 design, with 3 subjects enrolled into the first dosing cohort to receive RNK05047 at the starting dose of 0.75 mg/kg.
In Part 2, once RP2D has been established, additional subjects (3 to 5 cohorts of approximately 15 subjects per cohort) will be enrolled in the cohort-expansion phase of the study. Tumor types for these cohorts will be determined based on data from the dose-escalation phase of the study and emerging results from preclinical studies or other scientific data. These dose expansion cohorts in all groups may be done concurrently.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 32
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description RNK05047 RNK05047 Dose-escalation of RNK05047 IV infusion
- Primary Outcome Measures
Name Time Method Part 1: Incidence of DLTs through 1 cycle/4 weeks Part 2: Incidence of TEAEs through study completion, an average of 1 year Part 1: 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: Disease Control Rate (DCR) 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
- Secondary Outcome Measures
Name Time Method Part 1: ORR based on RECIST 1.1/RECIL 2017 through study completion, an average of 1 year Part 2: Overall Survival (OS) through study completion, an average of 1 year Part 2: Plasma concentration RNK05047 Through Cycle 3/approximately 12 weeks Part 1: PFS based on RECIST 1.1/RECIL 2017 through study completion, an average of 1 year Part 1: Plasma concentration RNK05047 Through Cycle 3/approximately 12 weeks Part 1: DoR based on RECIST 1.1/RECIL 2017 through study completion, an average of 1 year Part 1: DCR based on RECIST 1.1/RECIL 2017 through study completion, an average of 1 year
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (5)
Cancer Hospital, Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Emory University Winship Cancer Institute
🇺🇸Atlanta, Georgia, United States
Norton Cancer Institute
🇺🇸Louisville, Kentucky, United States
Weill Cornell - NY Presbyterian Hospital
🇺🇸New York, New York, United States