Advanced Gastrointestinal TumorsPhase 1/2NCT04612712
A Phase 1/2 Study of Donafenib in Combination With KN046 in Advanced Gastrointestinal Tumors
A Phase 1/2 study testing Donafenib Tosilate Tablets and KN046 Injection in people with Advanced Gastrointestinal Tumors, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
Trial summary
This study is an open, multi-center clinical trial, the purpose is to study the safety and preliminary efficacy of Donafenib combined with KN046 in subjects with Advanced Gastrointestinal Tumors. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Gastrointestinal Tumors
- What is being tested?
- Donafenib Tosilate Tablets and KN046 Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 19 Jan 2021to 30 Jun 2022
- Phase
- Phase 1/2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18-70 years;
- Phase I dose escalation: Advanced gastric cancer, esophageal cancer, colorectal cancer, hepatocellular carcinoma, pancreatic cancer (other than pancreatic neuroendocrine tumors) and intrahepatic cholangiocarcinoma that failed standard treatments confirmed by histopathology and/or cytology; Among them, the Child-Pugh score of liver function in patients with hepatocellular carcinoma is less than 5,
- Phase II advanced hepatocellular carcinoma Dose expansion: Patients with advanced hepatocellular carcinoma who are clinically diagnosed or confirmed by histopathology and/or cytology and are not suitable for surgical resection; The patient has not undergone first-line systemic treatment [small molecule targeted drugs (such as sorafenib, lenvatinib, etc.), systemic chemotherapy] and tumor immunotherapy (anti-PD-1/L1, CTLA-4, etc.); Child-Pugh score of liver function ≤ 6;
- Has at least one measurable lesion based on RECIST 1.1;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- Life expectancy ≥12 weeks;
- Patients must be able to understand and willing to sign a written informed consent document.
Who cannot join
- Subjects who have previously received immune checkpoint inhibitors (such as anti-PD-1/L1, CTLA-4, etc.);
- History of interstitial lung disease or non-infectious pneumonia;
- Clinically obvious gastrointestinal abnormalities, which may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or patients undergoing total gastrectomy;
- Has received vaccination within 4 weeks prior to the first dose.
- Has participated in other anticancer drug clinical trials within 4 weeks.
- According to the judgement of the investigators, there are other factors that subjects are not suitable for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1/2 Dose Escalation and Expansion Study of Donafenib Tosilate Tablets in Combination With KN046 Injection in Advanced Gastrointestinal Tumors
This study is an open, multi-center clinical trial, the purpose is to study the safety and preliminary efficacy of Donafenib combined with KN046 in subjects with Advanced Gastrointestinal Tumors.
Read the detailed description
The study consists of dose escalation and dose expansion. The preset dose of Donafenib is 50 mg BID, 100 mg BID and 200 mg BID, and the preset dose of KN046 is 5 mg/kg Q3W. Dose expansion will enroll subjects who with advanced hepatocellular carcinoma.
- Conditions
- Advanced Gastrointestinal Tumors
- Being tested
- Donafenib Tosilate Tablets, KN046 Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donafenib Tosilate TabletsDrug
In the dose exploration phase (phase I) : three doses of Donafenib tosylate tablets [50 mg twice a day; 100 mg twice a day; 200 mg twice a day ] will be explored. In the dose expansion phase (phase II), patients with advanced hepatocellular carcinoma will be treated at the recommended dose for phase 2(RP2D).The RP2D will be determined by the dose escalation study.
KN046 InjectionBiological
5mg/kg Q3W
| Study group | Role | What they receive |
|---|---|---|
| Donafenib+ KN046 | Experimental | Donafenib 50mg BID/100 mg BID/200 mg BID orally + KN046 5mg/kg Q3W iv Receives: Drug: Donafenib Tosilate Tablets; Biological: KN046 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I part - Tolerability of Donafenib in Combination With KN046
Evaluated by severity of drug-related adverse events (AEs), serious adverse events (SAEs).
Measured: 21 days after the first dose of Donafenib and KN046
Phase II part - Objective response rate(ORR)
Objective response rate based on the RECIST 1.1 by investigator. Percentage of subjects achieving complete response (CR) and partial response (PR).
Measured: From the time of initial administration until intolerant toxicity, disease progression, withdrawal of ICF, loss of follow-up, death or early study termination occurs (whichever occurs first),assessed up to 36 months]
Secondary outcomes (2)
Duration of Response (DOR)
It is defined as time between the date of first radiographic documented objective response and the date of the radiographic documented disease progression.
Measured: Through study completion, an expected average of 3 year
Progression-Free Survival (PFS)
PFS is defined as the time from date of enrollment to the date of the first objectively documented tumor progression or death due to any cause.
Measured: Through study completion, an expected average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start19 Jan 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Why it stopped: Due to R\&D strategy adjustments; no safety issues involved.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Gastrointestinal TumorsStudies of the same condition, open and under way.
- More trials run by Suzhou Zelgen Biopharmaceuticals Co.,LtdThe sponsor's other registered studies.
- 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Tianshu Liu, PhD, Study chair, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04612712
- Sponsor's protocol ID
- KN046D-C-101
- Status last verified
- Nov 2022
- First submitted
- 29 Oct 2020
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Dose Escalation and Expansion Study of Donafenib Tosilate Tablets in Combination With KN046 Injection in Advanced Gastrointestinal Tumors
- ClinicalTrials.gov ID
- NCT04612712
- Acronym / sponsor ID
- KN046D-C-101
- Conditions
- Advanced Gastrointestinal Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to R\&D strategy adjustments; no safety issues involved.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Collaborators
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 3 Nov 2020 (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 study is an open, multi-center clinical trial, the purpose is to study the safety and preliminary efficacy of Donafenib combined with KN046 in subjects with Advanced Gastrointestinal Tumors.
Detailed description
The study consists of dose escalation and dose expansion. The preset dose of Donafenib is 50 mg BID, 100 mg BID and 200 mg BID, and the preset dose of KN046 is 5 mg/kg Q3W. Dose expansion will enroll subjects who with advanced hepatocellular carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Donafenib+ KN046 | Experimental | Drug: Donafenib Tosilate Tablets, Biological: KN046 InjectionDonafenib 50mg BID/100 mg BID/200 mg BID orally + KN046 5mg/kg Q3W iv |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female aged 18-70 years;
- Phase I dose escalation: Advanced gastric cancer, esophageal cancer, colorectal cancer, hepatocellular carcinoma, pancreatic cancer (other than pancreatic neuroendocrine tumors) and intrahepatic cholangiocarcinoma that failed standard treatments confirmed by histopathology and/or cytology; Among them, the Child-Pugh score of liver function in patients with hepatocellular carcinoma is less than 5,
- Phase II advanced hepatocellular carcinoma Dose expansion: Patients with advanced hepatocellular carcinoma who are clinically diagnosed or confirmed by histopathology and/or cytology and are not suitable for surgical resection; The patient has not undergone first-line systemic treatment [small molecule targeted drugs (such as sorafenib, lenvatinib, etc.), systemic chemotherapy] and tumor immunotherapy (anti-PD-1/L1, CTLA-4, etc.); Child-Pugh score of liver function ≤ 6;
- Has at least one measurable lesion based on RECIST 1.1;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
Key exclusion criteria (6 listed)
- Subjects who have previously received immune checkpoint inhibitors (such as anti-PD-1/L1, CTLA-4, etc.);
- History of interstitial lung disease or non-infectious pneumonia;
- Clinically obvious gastrointestinal abnormalities, which may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or patients undergoing total gastrectomy;
- Has received vaccination within 4 weeks prior to the first dose.
- Has participated in other anticancer drug clinical trials within 4 weeks.
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 |
|---|---|---|
| Donafenib Tosilate TabletsIn the dose exploration phase (phase I) : three doses of Donafenib tosylate tablets [50 mg twice a day; 100 mg twice a day; 200 mg twice a day ] will be explored. In the dose expansion phase (phase II), patients with advanced hepatocellular carcinoma will be treated at the recommended dose for phase 2(RP2D).The RP2D will be determined by the dose escalation study. | Drug | Donafenib+ KN046 |
| KN046 Injection5mg/kg Q3W | Biological | Donafenib+ KN046 |
Primary outcome
Phase I part - Tolerability of Donafenib in Combination With KN046
Time frame: 21 days after the first dose of Donafenib and KN046
Evaluated by severity of drug-related adverse events (AEs), serious adverse events (SAEs).
Phase II part - Objective response rate(ORR)
Time frame: From the time of initial administration until intolerant toxicity, disease progression, withdrawal of ICF, loss of follow-up, death or early study termination occurs (whichever occurs first),assessed up to 36 months]
Objective response rate based on the RECIST 1.1 by investigator. Percentage of subjects achieving complete response (CR) and partial response (PR).
2 secondary outcomes
Duration of Response (DOR)
Time frame: Through study completion, an expected average of 3 year
Progression-Free Survival (PFS)
Time frame: Through study completion, an expected average of 3 year
Results and safety
The study was stopped early (reason given: Due to R\&D strategy adjustments; no safety issues involved.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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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.
Tianshu Liu, PhD study chair
Shanghai Zhongshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Donafenib Tosilate Tablets and KN046 Injection in people with Advanced Gastrointestinal Tumors, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
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 7 inclusion and 6 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 1 May 2026. 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 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?
The study was stopped early (reason given: Due to R\&D strategy adjustments; no safety issues involved.). 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?
Phase I part - Tolerability of Donafenib in Combination With KN046 (time frame: 21 days after the first dose of Donafenib and KN046). 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?
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 1 May 2026.