A Study of RNK05047 in Subjects With Advanced Solid Tumors/Diffuse Large B-cell Lymphoma (CHAMP-1)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRanok Therapeutics (Hangzhou) Co., Ltd.
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- RNK05047
Treatment groups
32 Participants
are divided into 1 treatment groupLocations
5China
Beijing Cancer Hospital100142, BeijingBeijing Municipality, China
Cancer Hospital, Chinese Academy of Medical Sciences100021, BeijingBeijing Municipality, China
United States
Emory University Winship Cancer Institute30322, AtlantaGeorgia, United States
Norton Cancer Institute40202, LouisvilleKentucky, United States
Sponsors and collaborators
Ranok Therapeutics (Hangzhou) Co., Ltd.
Lead sponsor
Source ClinicalTrials.gov