Colorectal Cancer with Hepatic MetastasesPhase 2NCT06834399

TATE and KN046 in MCRC

A Phase 2 study testing KN046 （PD-L1/CTLA4 BsAb） and TATE：Intra-arterial Administration of Tirapazamine followed by Transarterial Embolization in people with Colorectal Cancer with Hepatic Metastases, run by Zhejiang Raygene Pharmaceuticals Co., Ltd at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

A single-arm, multicenter, Phase IIA study of Intra-arterial Administration of Tirapazamine followed by Transarterial Embolization (TATE) and KN046 (recombinant humanized anti-PD-L1/CTLA-4 bispecific single-domain antibody Fc fusion protein injection) in patients with liver metastases from colorectal cancer. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Colorectal Cancer with Hepatic Metastases
What is being tested?: KN046 （PD-L1/CTLA4 BsAb） and TATE：Intra-arterial Administration of Tirapazamine followed by Transarterial Embolization
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 1 siteChina
Study dates: 27 Apr 2023to 9 Jan 2025
Phase: Phase 2
Are there results?: None posted in the registry

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

Liver metastatic MSS/pMMR-mCRC;
mCRC progressed on at least two lines of standard chemotherapy;
Measurable disease;
ECOG 0-1;
Adequate organ function

Who cannot join

Prior organ transplantation;
Oxygen saturation less than 92% in room air;
Prior autoimmune disorder;
Major GI bleeding in the last 2 months;
Prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody therapy, or any other antibody or drug that specifically targets T-cell co-stimulation or immune checkpoint pathways.

Trial locations and contacts

1 site in 1 country.

China1 site

Sun Yat-sen University Cancer Center
Guangzhou, Guangdong

Other trials in China

About this study

Official title: Phase IIA Clinical Trial of Intra-arterial Administration of Tirapazamine Followed by Transarterial Embolization （TATE）and KN046 for the Treatment of Advanced Colorectal Cancer with Liver Metastasis (MSS/pMMR)

Conditions: Colorectal Cancer with Hepatic Metastases
Being tested: KN046 （PD-L1/CTLA4 BsAb）, TATE：Intra-arterial Administration of Tirapazamine followed by Transarterial Embolization
Keywords: Colorectal Cancer, Liver Metastasis, Tirapazamine, KN046 (PD-L1/CTLA-4 Bispecific Antibody)
Medical subject headings: Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

KN046 （PD-L1/CTLA4 BsAb）Drug
KN046 is administered every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, loss to follow-up, death, study end, or other discontinuation criteria are met.
TATE：Intra-arterial Administration of Tirapazamine followed by Transarterial EmbolizationProcedure or surgery
TATE treatment is given every 21 days. Patients receive two initial cycles. Whether to continue TATE treatment from the third cycle onward is decided by the investigator based on tumor necrosis. If a patient experiences intrahepatic tumor progression (recurrence or new tumors) during follow-up after the third cycle and still meets the treatment criteria, additional TATE treatment may be given.

Study groups in NCT06834399
Study group	Role	What they receive
TATE and KN046	Experimental	On Day 1, patients will receive KN046 at a dose of 5 mg/kg. On Day 8 (+/-1), patients will receive TATE (Tirapazamine 35 mg). Each treatment cycle is 21 days. Patients will receive two cycles of treatment. After necrosis of liver tumors, whether to continue TATE treatment in the third cycle and beyond will be decided by the study physician based on the extent of tumor necrosis. Receives: Drug: KN046 （PD-L1/CTLA4 BsAb）; Procedure: TATE：Intra-arterial Administration of Tirapazamine followed by Transarterial Embolization

What is being measured

The primary outcome is the main question the study is designed to answer.

ORR
Objective Response Rate (assessed by mRECIST/RECIST)
Measured: 24 months
OS
Overall Survival
Measured: 24 months

Secondary outcomes (3)

DCR
Disease control rate
Measured: 24 months
PFS
Progression-free survival
Measured: 24 months
survival rates
6-month, 1-year, and 2-year survival rates
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Apr 20239 Jan 2025

First posted19 Feb 2025
Study start27 Apr 2023
Primary completion17 Dec 2024
Study completion9 Jan 2025

Why it stopped: Business Operation Strategy Adjustment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Colorectal Cancer with Hepatic MetastasesStudies 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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06834399
Sponsor's protocol ID: RG-KN-001
Status last verified: Feb 2025
First submitted: 13 Feb 2025
Last updated: 19 Feb 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: International meeting report or medical Journal publication

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruitingPhase 2
A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer
Metastatic Colorectal Cancer
Recruiting
TheraSphere Japan Pre-Market Study
Liver Neoplasms
Active, not recruiting
Surgical Margin Assessment Using Intra-operative High-resolution PET/CT in Patients With Cancers Referred to Surgical Resection, an Exploratory Pilot Study
Breast Cancer, Head and Neck Cancers
Not yet recruitingPhase 1/2
The QL1706 Combined With Chemotherapy and Either Cetuximab or Bevacizumab in Potentially Resectable Colorectal Cancer Patients With Liver Metastases
Colorectal Cancer Metastatic to Liver

All Colorectal Cancer with Hepatic Metastases trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase IIA Clinical Trial of Intra-arterial Administration of Tirapazamine Followed by Transarterial Embolization （TATE）and KN046 for the Treatment of Advanced Colorectal Cancer with Liver Metastasis (MSS/pMMR)
ClinicalTrials.gov ID: NCT06834399
Acronym / sponsor ID: RG-KN-001
Conditions: Colorectal Cancer with Hepatic Metastases
Keywords: Colorectal Cancer, Liver Metastasis, Tirapazamine, KN046 (PD-L1/CTLA-4 Bispecific Antibody)
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Business Operation Strategy Adjustment
Enrolment: 42 participants (actual)
Lead sponsor: Zhejiang Raygene Pharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
Collaborators: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Study start: 27 Apr 2023 (actual)
Primary completion: 17 Dec 2024 (actual)
Study completion: 9 Jan 2025 (actual)
First posted: 19 Feb 2025 (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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
TATE and KN046	Experimental	Drug: KN046 （PD-L1/CTLA4 BsAb）, Procedure: TATE：Intra-arterial Administration of Tirapazamine followed by Transarterial EmbolizationOn Day 1, patients will receive KN046 at a dose of 5 mg/kg. On Day 8 (+/-1), patients will receive TATE (Tirapazamine 35 mg). Each treatment cycle is 21 days. Patients will receive two cycles of treatment. After necrosis of liver tumors, whether to continue TATE treatment in the third cycle and beyond will be decided by the study physician based on the extent of tumor necrosis.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Liver metastatic MSS/pMMR-mCRC;
mCRC progressed on at least two lines of standard chemotherapy;
Measurable disease;
ECOG 0-1;
Adequate organ function

Key exclusion criteria (5 listed)

Prior organ transplantation;
Oxygen saturation less than 92% in room air;
Prior autoimmune disorder;
Major GI bleeding in the last 2 months;
Prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody therapy, or any other antibody or drug that specifically targets T-cell co-stimulation or immune checkpoint pathways.

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
KN046 （PD-L1/CTLA4 BsAb）KN046 is administered every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, loss to follow-up, death, study end, or other discontinuation criteria are met.	Drug	TATE and KN046
TATE：Intra-arterial Administration of Tirapazamine followed by Transarterial EmbolizationTATE treatment is given every 21 days. Patients receive two initial cycles. Whether to continue TATE treatment from the third cycle onward is decided by the investigator based on tumor necrosis. If a patient experiences intrahepatic tumor progression (recurrence or new tumors) during follow-up after the third cycle and still meets the treatment criteria, additional TATE treatment may be given.	Procedure or surgery	TATE and KN046

Primary outcome

ORR
Time frame: 24 months
Objective Response Rate (assessed by mRECIST/RECIST)
OS
Time frame: 24 months
Overall Survival

3 secondary outcomes

DCR
Time frame: 24 months
PFS
Time frame: 24 months
survival rates
Time frame: 24 months

Results and safety

The study was stopped early (reason given: Business Operation Strategy Adjustment). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
Individual participant dataSharing planned: No. International meeting report or medical Journal publication

Related trials for Colorectal Cancer with Hepatic Metastases

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruitingPhase 2
A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer
Metastatic Colorectal Cancer
Recruiting
TheraSphere Japan Pre-Market Study
Liver Neoplasms
Active, not recruiting
Surgical Margin Assessment Using Intra-operative High-resolution PET/CT in Patients With Cancers Referred to Surgical Resection, an Exploratory Pilot Study
Breast Cancer, Head and Neck Cancers
Not yet recruitingPhase 1/2
The QL1706 Combined With Chemotherapy and Either Cetuximab or Bevacizumab in Potentially Resectable Colorectal Cancer Patients With Liver Metastases
Colorectal Cancer Metastatic to Liver

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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in 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 phase mean?

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?

The study was stopped early (reason given: Business Operation Strategy Adjustment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06834399.

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 19 Feb 2025.