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Back|NCT05487170Recruiting
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)

Phase
Phase 1/Phase 2
Sponsor
Ranok Therapeutics (Hangzhou) Co., Ltd.
Enrollment
32
Timeline
Jul 2022 → Sep 2025
About This Study

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

Inclusion Criteria

  • 1Pathologically documented locally advanced or metastatic solid tumor
  • 2Refractory or intolerant to all available standard-of-care therapies for advanced disease
  • 3Measurable disease
  • 4Archived tumor tissue collected
  • 5ECOG Performance Status of 0 or 1
  • 6BMI ≥ 18 kg/m2
  • 7Adequate liver, renal, hematologic, and coagulation parameters
  • 8Negative 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
  • 9Males 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.
  • 10Must 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

  • 1Concurrent 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
  • 2Unresolved toxicities from prior anticancer therapy, defined as not having resolved according to CTCAE version 5.0 Grade ≤ 1, excluding Grade 1 alopecia
  • 3Presence or suspicion of active central nervous system (CNS) metastases and/or leptomeningeal carcinomatosis
  • 4Peripheral neurotoxicity ≥ Grade 2 according to CTCAE v5.0
  • 5Known active infection with HIV, HTLV-1, hepatitis B or C
  • 6Women who are pregnant or breastfeeding
  • 7History of another malignancy unless the subject has been treated with curative intent for this malignancy

Locations

5 sites participating in this study

Emory University Winship Cancer Institute

Atlanta, Georgia 30322

Completed

Norton Cancer Institute

Louisville, Kentucky 40202

Completed

Weill Cornell - NY Presbyterian Hospital

New York, New York 10065

Completed
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →