Clinical trial · Interventional
A Study of RNK05047 in Subjects With Advanced Solid Tumors/Diffuse Large B-cell Lymphoma (CHAMP-1)
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| DLBCL | Diffuse Large B-Cell Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RNK05047 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RNK05047
- description
- Dose-escalation of RNK05047 IV infusion
- interventionNames
- Drug: RNK05047
Primary outcomes (7)
- measure
- Part 1: Incidence of DLTs
- timeFrame
- through 1 cycle/4 weeks
- measure
- Part 1: Incidence of TEAEs
- timeFrame
- through study completion, an average of 1 year
- measure
- Part 2: Incidence of TEAEs
- timeFrame
- through study completion, an average of 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available