Evaluating RNK05047 for advanced solid tumors and DLBCL

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human, Phase 1/2 open-label study designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RNK05047 administered via intravenous infusion to patients with advanced solid tumors, including diffuse large B-cell lymphoma (DLBCL). The study consists of two parts: a dose escalation phase where patients receive RNK05047 weekly for three weeks, followed by a cohort expansion phase that will enroll additional subjects based on the established recommended Phase 2 dose (RP2D). The study aims to identify effective dosing and gather data on the drug's impact on various tumor types.

Why it matters

Who can join: the full rules

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

Where it's running

• Cancer Hospital, Chinese Academy of Medical Sciences
  Beijing, Beijing Municipality, China Recruiting
• Beijing Cancer Hospital
  Beijing, Beijing Municipality, China Recruiting
• Emory University Winship Cancer Institute
  Atlanta, Georgia, United States Completed
• Norton Cancer Institute
  Louisville, Kentucky, United States Completed
• Weill Cornell - NY Presbyterian Hospital
  New York, New York, United States Completed

Study contacts

• Study coordinator: Linda Grummer, RN, BSN
• Email: lindagrummer@ranoktherapeutics.com
• Phone: 405-921-1605

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.