Advanced Solid TumorPhase 1/2NCT05487170
A Study of RNK05047 in Subjects With Advanced Solid Tumors/Diffuse Large B-cell Lymphoma (CHAMP-1)
A Phase 1/2 study testing RNK05047 in people with Advanced Solid Tumor and DLBCL, run by Ranok Therapeutics (Hangzhou) Co., Ltd. at 5 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, DLBCL
- What is being tested?
- RNK05047
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 12 Jul 2022to 1 Sep 2025
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
United States3 sites
- Completed
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322
- Completed
Norton Cancer Institute
Louisville, Kentucky, 40202
- Completed
Weill Cornell - NY Presbyterian Hospital
New York, New York, 10065
China2 sites, 2 recruiting
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Ning Li, MD
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Yuquin Song, MD PhD
About this study
Official title: A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Chaperone-mediated Protein Degrader RNK05047 in Subjects With Advanced Solid Tumors (CHAMP-1)
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.
Read the detailed 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.
- Conditions
- Advanced Solid Tumor, DLBCL
- Being tested
- RNK05047
- Keywords
- protein degrader
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RNK05047Drug
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).
| Study group | Role | What they receive |
|---|---|---|
| RNK05047 | Experimental | Dose-escalation of RNK05047 IV infusion Receives: Drug: RNK05047 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Incidence of DLTs
Measured: through 1 cycle/4 weeks
Part 1: Incidence of TEAEs
Measured: through study completion, an average of 1 year
Part 2: Incidence of TEAEs
Measured: through study completion, an average of 1 year
Part 2: Objective response rate (ORR) based on RECIST 1.1/RECIL 2017
Measured: through study completion, an average of 1 year
Part 2: Duration of response (DoR) based on RECIST 1.1/RECIL 2017
Measured: through study completion, an average of 1 year
Part 2: Progression-free Survival (PFS) based on RECIST 1.1/RECIL 2017
Measured: through study completion, an average of 1 year
Part 2: Disease Control Rate (DCR) based on RECIST 1.1/RECIL 2017
Measured: through study completion, an average of 1 year
Secondary outcomes (7)
Part 1: Plasma concentration RNK05047
Measured: Through Cycle 3/approximately 12 weeks
Part 1: ORR based on RECIST 1.1/RECIL 2017
Measured: through study completion, an average of 1 year
Part 1: DoR based on RECIST 1.1/RECIL 2017
Measured: through study completion, an average of 1 year
Part 1: PFS based on RECIST 1.1/RECIL 2017
Measured: through study completion, an average of 1 year
Part 1: DCR based on RECIST 1.1/RECIL 2017
Measured: through study completion, an average of 1 year
Part 2: Plasma concentration RNK05047
Measured: Through Cycle 3/approximately 12 weeks
Part 2: Overall Survival (OS)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start12 Jul 2022
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ranok Therapeutics (Hangzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Linda Grummer, Study director, Ranok Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05487170
- Sponsor's protocol ID
- RNK05047-01
- Status last verified
- Feb 2025
- First submitted
- 12 Jul 2022
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Chaperone-mediated Protein Degrader RNK05047 in Subjects With Advanced Solid Tumors (CHAMP-1)
- ClinicalTrials.gov ID
- NCT05487170
- Acronym / sponsor ID
- RNK05047-01
- Conditions
- Advanced Solid Tumor, DLBCL
- Keywords
- protein degrader
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Ranok Therapeutics (Hangzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 4 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RNK05047 | Experimental | Drug: RNK05047Dose-escalation of RNK05047 IV infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RNK05047RNK05047 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). | Drug | RNK05047 |
Primary outcome
Part 1: Incidence of DLTs
Time frame: through 1 cycle/4 weeks
Part 1: Incidence of TEAEs
Time frame: through study completion, an average of 1 year
Part 2: Incidence of TEAEs
Time frame: through study completion, an average of 1 year
Part 2: Objective response rate (ORR) based on RECIST 1.1/RECIL 2017
Time frame: through study completion, an average of 1 year
Part 2: Duration of response (DoR) based on RECIST 1.1/RECIL 2017
Time frame: through study completion, an average of 1 year
Part 2: Progression-free Survival (PFS) based on RECIST 1.1/RECIL 2017
Time frame: through study completion, an average of 1 year
Part 2: Disease Control Rate (DCR) based on RECIST 1.1/RECIL 2017
Time frame: through study completion, an average of 1 year
7 secondary outcomes
Part 1: Plasma concentration RNK05047
Time frame: Through Cycle 3/approximately 12 weeks
Part 1: ORR based on RECIST 1.1/RECIL 2017
Time frame: through study completion, an average of 1 year
Part 1: DoR based on RECIST 1.1/RECIL 2017
Time frame: through study completion, an average of 1 year
Part 1: PFS based on RECIST 1.1/RECIL 2017
Time frame: through study completion, an average of 1 year
Part 1: DCR based on RECIST 1.1/RECIL 2017
Time frame: through study completion, an average of 1 year
Part 2: Plasma concentration RNK05047
Time frame: Through Cycle 3/approximately 12 weeks
Part 2: Overall Survival (OS)
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Advanced Solid Tumor
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-)
RecruitingPhase 1/2
A 2-part Phase 1/2 Open-label Trial on ODM-212
Mesothelioma, Pancreatic Cancer
Active, not recruitingPhase 2
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Linda Grummer study director
Ranok Therapeutics
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing RNK05047 in people with Advanced Solid Tumor and DLBCL, run by Ranok Therapeutics (Hangzhou) Co., Ltd. at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Linda Grummer, RN, BSN (405-921-1605, lindagrummer@ranoktherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Incidence of DLTs (time frame: through 1 cycle/4 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.