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

Ranok Therapuetics

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Advanced Solid Tumor

DLBCL

Treatments

Drug: RNK05047

Study type

Interventional

Funder types

Industry

Identifiers

NCT05487170

RNK05047-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment

32 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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