RECRUITING

A Study of RNK05047 in Subjects With Advanced Solid Tumors/Diffuse Large B-cell Lymphoma (CHAMP-1)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Chaperone-mediated Protein Degrader RNK05047 in Subjects With Advanced Solid Tumors (CHAMP-1)

Quick Facts

Study Start:2022-07-12
Study Completion:2025-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05487170

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pathologically documented locally advanced or metastatic solid tumor
  2. * Refractory or intolerant to all available standard-of-care therapies for advanced disease
  3. * Measurable disease
  4. * Archived tumor tissue collected
  5. * ECOG Performance Status of 0 or 1
  6. * BMI ≥ 18 kg/m2
  7. * Adequate liver, renal, hematologic, and coagulation parameters
  8. * 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
  9. * 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.
  10. * 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.
  1. * 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
  2. * Unresolved toxicities from prior anticancer therapy, defined as not having resolved according to CTCAE version 5.0 Grade ≤ 1, excluding Grade 1 alopecia
  3. * Presence or suspicion of active central nervous system (CNS) metastases and/or leptomeningeal carcinomatosis
  4. * Peripheral neurotoxicity ≥ Grade 2 according to CTCAE v5.0
  5. * Known active infection with HIV, HTLV-1, hepatitis B or C
  6. * Women who are pregnant or breastfeeding
  7. * History of another malignancy unless the subject has been treated with curative intent for this malignancy

Contacts and Locations

Study Contact

Linda Grummer, RN, BSN
CONTACT
405-921-1605
lindagrummer@ranoktherapeutics.com

Principal Investigator

Linda Grummer
STUDY_DIRECTOR
Ranok Therapeutics

Study Locations (Sites)

Emory University Winship Cancer Institute
Atlanta, Georgia, 30322
United States
Norton Cancer Institute
Louisville, Kentucky, 40202
United States
Weill Cornell - NY Presbyterian Hospital
New York, New York, 10065
United States

Collaborators and Investigators

Sponsor: Ranok Therapeutics (Hangzhou) Co., Ltd.

  • Linda Grummer, STUDY_DIRECTOR, Ranok Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-12
Study Completion Date2025-03

Study Record Updates

Study Start Date2022-07-12
Study Completion Date2025-03

Terms related to this study

Keywords Provided by Researchers

  • protein degrader

Additional Relevant MeSH Terms

  • Advanced Solid Tumor
  • DLBCL