To hear about similar clinical trials, please enter your email below
Trial Title:
A Study of RNK05047 in Subjects With Advanced Solid Tumors/Diffuse Large B-cell Lymphoma (CHAMP-1)
NCT ID:
NCT05487170
Condition:
Advanced Solid Tumor
DLBCL
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
protein degrader
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
RNK05047
Description:
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).
Arm group label:
RNK05047
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Emory University Winship Cancer Institute
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Recruiting
Contact:
Last name:
Adam Burgess
Phone:
404-712-9858
Email:
adam.burgess@emory.edu
Investigator:
Last name:
Donald Harvey III, PharmD
Email:
Principal Investigator
Facility:
Name:
Norton Cancer Institute
Address:
City:
Louisville
Zip:
40202
Country:
United States
Status:
Recruiting
Investigator:
Last name:
John Hamm, MD
Email:
Principal Investigator
Facility:
Name:
Weill Cornell - NY Presbyterian Hospital
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Casey Owens, MPH
Email:
cdo4001@med.cornell.edu
Investigator:
Last name:
Manuel Hidalgo Medina, MD, PhD
Email:
Principal Investigator
Start date:
July 12, 2022
Completion date:
March 2025
Lead sponsor:
Agency:
Ranok Therapeutics (Hangzhou) Co., Ltd.
Agency class:
Industry
Source:
Ranok Therapuetics Co. Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05487170
