Advanced Solid TumorPhase 1NCT05309512
Clinical Study of KN052 in Chinese Subjects With Advanced Solid Tumors
A Phase 1 study testing KN052 in people with Advanced Solid Tumor, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd at 1 site in China.
Trial summary
This is a phase Ia/Ib open, multicenter study of solid tumor subjects in China.Including dose increasing period and cohort expansion period.A BOIN design is used in the dose escalation phase,a total of 8 dose groups were designed.In the expansion phase of the cohort, 15 to 30 subjects will be enrolled in a specific… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- KN052
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 27 May 2022to 14 Nov 2023
- Phase
- Phase 1
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject can understand the informed consent, participate in and sign the informed consent voluntarily;
- Subjects are at least 18 years old and <80 years old on the day of signing the informed consent, male or female, and are willing to follow the study procedures;
- Solid tumors were confirmed histologically or cytologically. Subjects in the dose escalation phase were late unresectable or metastatic entities Patients with cancer must have received standard care and have no other standard care options with a proven survival benefit; or Subjects with refractory solid tumors who could not tolerate or had contraindications to standard treatments, including chemotherapy, Targeted therapy;
- Measurable lesions at baseline according to RECIST 1.1; If subject has only 1 measurable disease at baseline The lesion area must not have received previous radiotherapy, or there is evidence of significant progression of the lesion after the end of radiotherapy;
- ECOG score 0 or 1;
- The laboratory test met the standard within 7 days before the first administration;
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- Life expectancy ≥3 months;
- Fertile female subjects must have a negative serum pregnancy test within 7 days prior to first dosing;
- Fertile female subjects or fertile male subjects with a partner agree to use highly effective contraception beginning 7 days before first dosing (annual failure rate less than 1%) until 24 weeks after completion of dosing.
Who cannot join
- Subjects with untreated active BMS; Subjects with pia meningeal metastasis;
- Received any other medication within 28 days prior to administration or 5 half-lives, whichever is shorter, but at least 2 weeks Interventional clinical trial therapy or other systemic chemotherapy, immunotherapy, targeted therapy and endocrine therapy;
- Major surgery (transabdominal, transthoracic, etc.) was performed within 28 days prior to administration; Not including diagnosis Sexual puncture or peripheral vascular access replacement);
- Had received radical radiotherapy within 3 months before administration in this study; 2 weeks prior to administration of palliative radiotherapy and radiotherapy are permitted Dose in line with local standards for palliative care;
- Systemic corticosteroid (≥10 mg/ day prednisone, or other corticosteroid equivalent) or immunosuppressant treatment is required for 7 consecutive days within 14 days prior to the first administration of the drug in this study;
- Received live vaccine (including live attenuated vaccine) within 28 days prior to administration;
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- Past or current interstitial pneumonia/lung disease requiring systematic hormone therapy;
- Previous or current autoimmune diseases;
- Other malignant tumors within 5 years prior to first administration;
- Suffering from uncontrolled complications;
- Toxicity of previous antitumor therapy did not return to CTCAE grade ≤1 (NCI-CTCAE V5.0) or baseline level;
- Previous history of allogeneic bone marrow or organ transplantation;
- In addition to anti-PD-(L)1 drugs or anti-CTLA-4 drugs, other antibodies/drugs (immune checkpoint) targeting T cell coregulatory proteins, such as OX40, 4-1BB,LAG3, TIM3, TIGIT or anti-CD127, have been used in the past;
- Previous history of intolerance to anaphylaxis to antibody drugs (grade ≥3 NCI-CTCAE V5.0); Any speed before A history of allergic reactions or uncontrolled asthma; Significant prior drug allergy;
- Pregnant and/or breastfeeding women;
- Other conditions that may affect the safety or compliance of the drug treatment in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ia/Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Antitumor Activity of KN052 in Chinese Subjects With Advanced Solid Tumors
This is a phase Ia/Ib open, multicenter study of solid tumor subjects in China.Including dose increasing period and cohort expansion period.A BOIN design is used in the dose escalation phase,a total of 8 dose groups were designed.In the expansion phase of the cohort, 15 to 30 subjects will be enrolled in a specific tumor type (liver cancer, stomach cancer, kidney cancer, melanoma, urothelial carcinoma, and other tumors determined by the SMC).
- Conditions
- Advanced Solid Tumor
- Being tested
- KN052
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KN052Biological
0.01mg/kg, 0.1mg/kg, 0.3mg/kg, 1mg/kg, 2mg/kg, 4mg/kg, 6mg/kg, 9mg/kg, RP2D once every two or three weeks intravenously
| Study group | Role | What they receive |
|---|---|---|
| KN052 single drug group | Experimental | The 8 dose groups in the dose increasing period were intravenous administration of 0.01mg/kg, 0.1mg/kg, 0.3mg/kg, 1mg/kg, 2mg/kg, 4mg/kg, 6mg/kg and 9mg/kg every two weeks, respectively. Based on the selected maximum tolerated dose of Q2W and in combination with the pharmacokinetic model, the sponsor would consider adding 1-2 Q3W treatment groups, with 6-12 patients in each dose group for DLT observation to explore the optimal dose regimen. The queue extension period is dose RP2D; Give it intravenously every two weeks or three weeks. Receives: Biological: KN052 |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD（ Maximum tolerated Dose）
MTD (Maximum tolerated Dose) is the dose for which the isotonic estimate of the toxicity rate is closest to the target toxicity rate based on the BOIN Design
Measured: Throughout the duration of the study，About 1 year
ORR（Objective Response Rate)
Objective response rate (ORR) was defined as the proportion of participants who achieve either complete response [CR] or partial response [PR] per Response Evaluation Criteria in Solid Tumors (RECIST v1.1）
Measured: Throughout the duration of the study，About 1 year
DOR(Duration Of Response)
Defined as the time from the first evaluation of objective response to the first evaluation of PD or death from any cause prior to PD
Measured: Throughout the duration of the study，About 1 year
Secondary outcomes (6)
The probability of adverse events
Including the occurrence probability of TESAE, TEAE, TRAE, irAE, IRR and AE above grade CTCAE 3
Measured: Throughout the duration of the study，About 1 year
Frequency of interruption, delay, and termination of dosing
The frequency of interrupted, delayed, and discontinued dosing was statistically analyzed by treatment dose group/cohort (tumor type)
Measured: Throughout the duration of the study，About 1 year
Frequency of immunogenicity
Frequency of occurrence of anti-KN052 antibody and neutralizing antibody
Measured: Throughout the duration of the study，About 1 year
Cmax of KN052
Maximum observed serum concentration of KN052
Measured: Throughout the duration of the study，About 1 year
Tmax of KN052
Time of Maximum observed serum concentration (Tmax) of KN052
Measured: Throughout the duration of the study，About 1 year
AUC(0-T) for KN052
Adjusted geometric means of area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (AUC(0-T)) for KN052
Measured: Throughout the duration of the study，About 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 Apr 2022
- Study start27 May 2022
- Primary completion14 Nov 2023
- Study completion14 Nov 2023
Why it stopped: Based on the differentiated R\&D strategy, the sponsor applies for the termination of the project.
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.
- More trials run by Jiangsu Alphamab 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309512
- Sponsor's protocol ID
- KN052-CHN-001
- Status last verified
- Jul 2023
- First submitted
- 9 Mar 2022
- Last updated
- 1 May 2024
- 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 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia/Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Antitumor Activity of KN052 in Chinese Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05309512
- Acronym / sponsor ID
- KN052-CHN-001
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based on the differentiated R\&D strategy, the sponsor applies for the termination of the project.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 27 May 2022 (actual)
- Primary completion
- 14 Nov 2023 (actual)
- Study completion
- 14 Nov 2023 (actual)
- First posted
- 4 Apr 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 phase Ia/Ib open, multicenter study of solid tumor subjects in China.Including dose increasing period and cohort expansion period.A BOIN design is used in the dose escalation phase,a total of 8 dose groups were designed.In the expansion phase of the cohort, 15 to 30 subjects will be enrolled in a specific tumor type (liver cancer, stomach cancer, kidney cancer, melanoma, urothelial carcinoma, and other tumors determined by the SMC).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KN052 single drug group | Experimental | Biological: KN052The 8 dose groups in the dose increasing period were intravenous administration of 0.01mg/kg, 0.1mg/kg, 0.3mg/kg, 1mg/kg, 2mg/kg, 4mg/kg, 6mg/kg and 9mg/kg every two weeks, respectively. Based on the selected maximum tolerated dose of Q2W and in combination with the pharmacokinetic model, the sponsor would consider adding 1-2 Q3W treatment groups, with 6-12 patients in each dose group for DLT observation to explore the optimal dose regimen. The queue extension period is dose RP2D; Give it intravenously every two weeks or three weeks. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The subject can understand the informed consent, participate in and sign the informed consent voluntarily;
- Subjects are at least 18 years old and <80 years old on the day of signing the informed consent, male or female, and are willing to follow the study procedures;
- Solid tumors were confirmed histologically or cytologically. Subjects in the dose escalation phase were late unresectable or metastatic entities Patients with cancer must have received standard care and have no other standard care options with a proven survival benefit; or Subjects with refractory solid tumors who could not tolerate or had contraindications to standard treatments, including chemotherapy, Targeted therapy;
- Measurable lesions at baseline according to RECIST 1.1; If subject has only 1 measurable disease at baseline The lesion area must not have received previous radiotherapy, or there is evidence of significant progression of the lesion after the end of radiotherapy;
- ECOG score 0 or 1;
Key exclusion criteria (16 listed)
- Subjects with untreated active BMS; Subjects with pia meningeal metastasis;
- Received any other medication within 28 days prior to administration or 5 half-lives, whichever is shorter, but at least 2 weeks Interventional clinical trial therapy or other systemic chemotherapy, immunotherapy, targeted therapy and endocrine therapy;
- Major surgery (transabdominal, transthoracic, etc.) was performed within 28 days prior to administration; Not including diagnosis Sexual puncture or peripheral vascular access replacement);
- Had received radical radiotherapy within 3 months before administration in this study; 2 weeks prior to administration of palliative radiotherapy and radiotherapy are permitted Dose in line with local standards for palliative care;
- Systemic corticosteroid (≥10 mg/ day prednisone, or other corticosteroid equivalent) or immunosuppressant treatment is required for 7 consecutive days within 14 days prior to the first administration of the drug in this study;
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 |
|---|---|---|
| KN0520.01mg/kg, 0.1mg/kg, 0.3mg/kg, 1mg/kg, 2mg/kg, 4mg/kg, 6mg/kg, 9mg/kg, RP2D once every two or three weeks intravenously | Biological | KN052 single drug group |
Primary outcome
MTD（ Maximum tolerated Dose）
Time frame: Throughout the duration of the study，About 1 year
MTD (Maximum tolerated Dose) is the dose for which the isotonic estimate of the toxicity rate is closest to the target toxicity rate based on the BOIN Design
ORR（Objective Response Rate)
Time frame: Throughout the duration of the study，About 1 year
Objective response rate (ORR) was defined as the proportion of participants who achieve either complete response [CR] or partial response [PR] per Response Evaluation Criteria in Solid Tumors (RECIST v1.1）
DOR(Duration Of Response)
Time frame: Throughout the duration of the study，About 1 year
Defined as the time from the first evaluation of objective response to the first evaluation of PD or death from any cause prior to PD
6 secondary outcomes
The probability of adverse events
Time frame: Throughout the duration of the study，About 1 year
Frequency of interruption, delay, and termination of dosing
Time frame: Throughout the duration of the study，About 1 year
Frequency of immunogenicity
Time frame: Throughout the duration of the study，About 1 year
Cmax of KN052
Time frame: Throughout the duration of the study，About 1 year
Tmax of KN052
Time frame: Throughout the duration of the study，About 1 year
AUC(0-T) for KN052
Time frame: Throughout the duration of the study，About 1 year
Results and safety
The study was stopped early (reason given: Based on the differentiated R\&D strategy, the sponsor applies for the termination of the project.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- 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.
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?
A Phase 1 study testing KN052 in people with Advanced Solid Tumor, run by Jiangsu Alphamab 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 9 inclusion and 16 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 2024. 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 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.
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: Based on the differentiated R\&D strategy, the sponsor applies for the termination of the project.). 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?
MTD（ Maximum tolerated Dose） (time frame: Throughout the duration of the study，About 1 year). The study lists 3 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 2024; AzTrials last refreshed its copy on 7 Nov 2026.