A Study of RNK05047 in Subjects With Advanced Solid Tumors/Diffuse Large B-cell Lymphoma (CHAMP-1)
Hematopoietic Malignancies
Lymphoma
Non-Hodgkin Lymphoma
Solid Tumor
Unknown Primary
18 Years and older, Male and Female
RNK05047-01 (primary)
NCI-2022-09252
Summary
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.
Objectives
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.
Eligibility
- Pathologically documented locally advanced or metastatic solid tumor
- Refractory or intolerant to all available standard-of-care therapies for advanced disease
- Measurable disease
- Adequate tumor sample
- 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.
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