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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-12

Study Completion Date

2025-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CC-90010 in Subjects With Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin's Lymphomas

NCT03220347

Lymphoma, Non-Hodgkin Neoplasms

TERMINATED PHASE1

A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-42756493 in Adult Participants With Advanced or Refractory Solid Tumors or Lymphoma

NCT01703481

Tumor or Lymphoma

COMPLETED PHASE1

A Safety and Dose-finding Study of JNJ-26481585 for Patients With Advanced Solid Malignancies and Lymphoma.

NCT00677105

Lymphoma Neoplasms

COMPLETED PHASE1

Study of RH-1 in Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma

NCT00558727

Advanced Solid Tumors Non-Hodgkin's Lymphoma

TERMINATED PHASE1

506U78 in Treating Patients With Lymphoma

NCT00005080

Anaplastic Large Cell Lymphoma Angioimmunoblastic T-cell Lymphoma Recurrent Adult T-cell Leukemia/Lymphoma +11 more

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In Part 1, enrolled subjects will receive IV RNK05047 once weekly for 3 consecutive weeks in a 4-week cycle (no treatment in the fourth week). The dose-escalation phase will follow a standard 3+3 design, with 3 subjects enrolled into the first dosing cohort to receive RNK05047 at the starting dose of 0.75 mg/kg.

In Part 2, once RP2D has been established, additional subjects (3 to 5 cohorts of approximately 15 subjects per cohort) will be enrolled in the cohort-expansion phase of the study. Tumor types for these cohorts will be determined based on data from the dose-escalation phase of the study and emerging results from preclinical studies or other scientific data. These dose expansion cohorts in all groups may be done concurrently.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced Solid Tumor DLBCL

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

RNK05047

Dose-escalation of RNK05047 IV infusion

Group Type EXPERIMENTAL

RNK05047

Intervention Type DRUG

RNK05047 is a chaperone-mediated protein degrader administered as IV infusion once weekly for 3 consecutive weeks in a 4-week cycle (no treatment in the fourth week).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

RNK05047

RNK05047 is a chaperone-mediated protein degrader administered as IV infusion once weekly for 3 consecutive weeks in a 4-week cycle (no treatment in the fourth week).

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No