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

ConditionsAdvanced Solid TumorDLBCL
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRanok Therapeutics (Hangzhou) Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • RNK05047

    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).

Treatment groups

32 Participants
are divided into 1 treatment group
Group A: RNK05047Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part 1: Incidence of DLTs

Time frame
through 1 cycle/4 weeks
2

Part 1: Incidence of TEAEs

Time frame
through study completion, an average of 1 year
3

Part 2: Incidence of TEAEs

Time frame
through study completion, an average of 1 year
4

Part 2: Objective response rate (ORR) based on RECIST 1.1/RECIL 2017

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

Part 1: Plasma concentration RNK05047

Time frame
Through Cycle 3/approximately 12 weeks
2

Part 1: ORR based on RECIST 1.1/RECIL 2017

Time frame
through study completion, an average of 1 year
3

Part 1: DoR based on RECIST 1.1/RECIL 2017

Time frame
through study completion, an average of 1 year
4

Part 1: PFS based on RECIST 1.1/RECIL 2017

Time frame
through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ranok Therapeutics (Hangzhou) Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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