Advanced or Metastatic Solid TumorsPhase 1NCT06196762
Phase I of XKH002 Injection in Patients
A Phase 1 study testing XKH002 Injection in people with Advanced or Metastatic Solid Tumors, run by Zhejiang Kanova Biopharmaceutical Co., LTD at 1 site in China.
Trial summary
This is a Phase 1, first-in-human (FIH), open-label, multicenter, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of XKH002 in patients with advanced or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic Solid Tumors
- What is being tested?
- XKH002 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 27 Nov 2023to 1 Apr 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older;
- Life expectancy at least 3 months.
- Histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumor. Patient has had disease progression on one or more standard treatment regimens, or could not tolerate the treatment, or has no available treatment options.
- 4 The physical status score of "Eastern Cancer Collaboration Group (ECOG)" (see Appendix 5) was 0-1;
- 5 According to RECIST v1.1, all patients must have at least one evaluable lesion at baseline.
- 6 For patients with stable BMS, all of the following criteria must be met:
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- At least 28 days after receiving specialist treatment for central nervous system disorders and at least 14 days after the last corticosteroid treatment.
- Clinical symptoms were stable after the last treatment: no new central nervous system metastases or radiotherapy complications.
- Note: Patients who developed new progressive clinical symptoms or spinal cord compression or pIA disease after the last treatment were excluded.
- 7 Laboratory test results during the screening period meet all of the following criteria:
- White blood cell count (WBC) ≥3.0×10^9/L;
- Neutrophil count (ANC) ≥1.5×10^9/L;
- Hemoglobin ≥90 g/L, assessed not having received blood transfusion within 7 days, and not dependent on erythropoietin (EPO);
- Platelets ≥90×10^9/L;
- Coagulation function: prothrombin time (PT), activated partial thromboplastin time (APTT), and International standardized ratio (INR) are all <1.5×ULN;
- No more than 1.5×ULN TBIL (no more than 3×ULN for Gilbert syndrome subjects);
- AST and/or ALT not higher than 3×ULN (or 5×ULN if liver metastasis is present);
- Albumin ≥30 g/L, no serum albumin infusion was assessed within 7 days;
- Creatinine clearance (CrCl) ≥50 mL/min (calculated by Cockcroft-Gault formula).
- 8 Women with reproductive potential (refers to women who have not had birth control surgery and have been menopausal for less than 2 years) have negative serum pregnancy tests (human chorionic gonadotropin);
- 9 Fertile patients (men who have not had birth control, women who have not had birth control and have been menopausal for less than 2 years) must use a highly effective contraceptive method (such as oral contraceptives, intrauterine devices, abstinence or barrier contraception combined with spermicides) during the study and continue to use contraception for 6 months after the last dose;
- 10 Sign a written informed consent to participate in the study.
Who cannot join
- 1 The presence or history of any of the following:
- Current or past autoimmune diseases or immunodeficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener's granuloma, Sjogren's syndrome, Guillain-Barre syndrome, or multiple sclerosis, with the following exceptions (see Appendix 4) :
- Patients with autoimmune related hypothyroidism who only need thyroid hormone replacement therapy are eligible to participate in the study;
- Patients with type 1 diabetes who receive insulin therapy for stable control are eligible to participate in the study;
- Patients with only dermatologic clinical manifestations of eczema, psoriasis, chronic lichen simple or vitiligo (e.g., excluding psoriatic arthritis) are eligible to participate in the study if they meet all of the following criteria:
- The skin rash area must be < 10% of the body surface area;
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- Good disease control at baseline, requiring only inefficient local glucocorticoid therapy;
- There has been no acute exacerbation of the pre-existing condition requiring psoralen plus A-band ultraviolet radiation, methotrexate, retinoic acid, biologics, oral calcineurin inhibitors, or highly effective or oral glucocorticoid therapy in the past 12 months.
- 2.Known allergy to any component of XKH002;
- 3 Subjects who had major surgery or were scheduled for surgery for any reason within the 4 weeks prior to screening or who the investigator felt might need surgery.
- 4 Radiotherapy (except palliative radiotherapy), chemotherapy, targeted therapy, endocrine therapy and other anti-tumor therapy, or other clinical trial drugs should be administered within 4 weeks before the first dose to the end of the trial; a) Patients receiving oral fluorouracil or small molecule targeted drugs were discontinued for ≤2 weeks or 5 half-lives (whichever is longer) before the first administration of the drug in this study; b) Study patients who were treated with mitomycin C or nitrosourea within 6 weeks prior to first administration of the drug; c) Chinese medicines with anti-tumor indications should be used within 2 weeks before the first use of the investigational drug.
- 5. Previous antibody/drug therapy targeting B7-H4 immune checkpoint;
- 6 Pregnant or lactating women;
- 7 Patients who have previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
- 8 Patients receiving erythropoietin (EPO) or thrombopoietin (TPO) within 2 weeks before the first dose, or colony stimulating factor (CSF) within 1 week before the first dose;
- 9 Confirmed by virological testing:
- Active hepatitis B (HBsAg positive with HBV-DNA>500 IU/mL or lower limit of study center detection [only when lower limit of study center detection is higher than 500 IU/mL]), or
- Active hepatitis C (patients with HCV antibody positive but HCV-RNA< lower limit of study center detection are allowed to be included), or
- Known human immunodeficiency virus infection history or human immunodeficiency virus (HIV) antibody positive;
- 10 ≥ grade 2 immune-related cardiotoxicity or ≥ grade 3 other immune-related adverse events after receiving immune checkpoint inhibitors or immune-modulating antibodies (immune-related hypothyroidism returning to grade 2 or below can be enrolled);
- 11 has not recovered from the toxicity of previous systemic therapy, and still has NCI-CTCAE v5.0≥2 toxicity (except alopecia, platinum treatment-related neuropathy can be relaxed to grade 2);
- 12 Concomitant diseases that may affect protocol adherence or interfere with trial results, including:
- Cardiovascular disease: New York Heart Association (NYHA) Heart function Grade III or IV; Myocardial infarction, variable angina, or unstable angina in the past 6 months; Degree III atrioventricular block, malignant ventricular arrhythmias, and other potentially life-threatening arrhythmias within the past 6 months; Atrial fibrillation with uncontrolled ventricular rate;
- 12-lead ECG QTcF >470 ms for women and >450 ms for men;
- Cardiac mural thrombosis, symptomatic deep vein thrombosis, and pulmonary embolism;
- Note: Cardiac ultrasound is required in patients with a history of atrial fibrillation to exclude atrial mural thrombosis.
- Lung diseases: interstitial pneumonia, chronic obstructive pulmonary disease, active pulmonary tuberculosis and symptomatic bronchospasm;
- Inflammatory gastrointestinal diseases, including Crohn's disease and ulcerative colitis;
- Chronic, active, clinically symptomatic infections, including bacterial, viral, fungal and other pathogens;
- Patients with severe complications such as active gastrointestinal bleeding, intestinal obstruction, intestinal paralysis, uncontrolled diabetes;
- Other severe and poorly managed comorbidities, in the opinion of the investigator.
- 13 Receive live vaccine within 30 days before the first dose, or plan to receive live vaccine within 30 days of the first dose. Live vaccines include, but are not limited to, measles, mumps, rubella, varicella/shingles, rabies and typhoid vaccines. Allow seasonal influenza vaccine (usually inactivated);
- 14 The novel coronavirus (COVID-19) vaccine is given within 14 days before the first dose, or is planned to be given within 14 days after the first dose, including the first dose, the second dose and the booster dose;
- 15 A history of mental disorders, or a history of psychotropic drug and/or alcohol abuse that cannot be abated;
- 16 Use immunosuppressive drugs. For corticosteroid users, systemic use of more than 10 mg/ day of prednisone or an equivalent dose of steroids must be discontinued at least 2 weeks before first administration of the test drug. Except in the following cases:
- Intranasal inhalation or local injection of corticosteroids;
- Continuous low dose (not exceeding 10 mg/d of prednisone or equivalent) for systemic use;
- Short-term (no more than 3 days) systemic use of high-dose steroids (more than 10 mg/ day of prednisone or equivalent).
- 17 Patients with clinically uncontrollable third space effusion who were judged unsuitable for inclusion by the investigators;
- 18 The investigator considered that there were other reasons why the patient was not suitable to participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Cancer Hospital
Beijing
Lin Shen, MD, 13911219511, doctorshenlin@sina.com
About this study
Official title: A Phase 1, First-in-human (FIH),Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of XKH002 in Patients With Advanced or Metastatic Solid Tumors
This is a Phase 1, first-in-human (FIH), open-label, multicenter, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of XKH002 in patients with advanced or metastatic solid tumors.
Read the detailed description
Overall Study Design:
This is a Phase 1, first-in-human (FIH), open-label, multicenter, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of XKH002 in patients with advanced or metastatic solid tumors.
The study will include 2 parts, dose escalation and dose expansion
Part 1: Dose Escalation Based on the results of previous non-clinical efficacy and toxicology experiments and the prediction of human PK, the initial dose was set at 0.3 mg/kg, and the dose was increased according to 5 dose groups: The 0.3, 1.0, 3.0, 10,20 mg/kg dose-escalation phase will include accelerated titration and a traditional 3+3 dose-escalation design, with 16-30 participants expected to participate in the study.
The MTD or MAD will be identified, and all the available PK, PD, tolerability and activity in addition to safety data will be evaluated to select the recommended dose for expansion (RDE).
Part 2: Dose Expansion Based on the results of the dose-escalation trial (safety/tolerability, initial efficacy, PK/PD, etc.), it is expected that 20 to 80 participants will be enrolled in the study by RDE dose expansion of monotherapy for selected subjects of 1 to 4 tumor types.
Number of Participants:
Approximately 16 to 30 patients will be enrolled in Part 1 (dose escalation). Approximately 20 to 80 patients will be enrolled in Part 2 (dose expansion).
- Conditions
- Advanced or Metastatic Solid Tumors
- Being tested
- XKH002 Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XKH002 InjectionDrug
Also called XKH002
240 mg/4 mL/vial（60 mg/mL）
| Study group | Role | What they receive |
|---|---|---|
| XKH002 | Experimental | A total of 5 dose cohorts will be enrolled and treated: 0.3, 1.0, 3.0, 10, and 20 mg/kg. The dose-escalation process will utilize both the accelerated titration and the conventional 3+3 methods. Receives: Drug: XKH002 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum tolerated dose (MTD) or the maximum administered dose (MAD) and the recommended dose for expansion (RDE)
To determine the maximum tolerated dose (MTD) or the maximum administered dose (MAD) and the recommended dose for expansion (RDE) of XKH002 in patients with advanced solid tumors
Measured: 24months
safety and tolerability
Incidence of treatment emergent adverse events (TEAEs), abnormal clinical laboratory tests, vital signs, electrocardiogram (ECG), and physical examination
Measured: 24months
Secondary outcomes (12)
pharmacokinetic (PK) parameters1
PK parameters including half-life (T1/2)
Measured: 24months
pharmacokinetic (PK) parameters2
PK parameters including clearance (CL)
Measured: 24months
pharmacokinetic (PK) parameters3
PK parameters including steady-state volume of distribution (Vss)
Measured: 24months
pharmacokinetic (PK) parameters4
PK parameters including area under the concentration-time (AUC)
Measured: 24months
pharmacokinetic (PK) parameters5
PK parameters including time to peak
Measured: 24months
pharmacokinetic (PK) parameters6
PK parameters including peak plasma concentration (Cmax)
Measured: 24months
antitumor activity1
To evaluate the antitumor activity of XKH002.Objective response rate (ORR)
Measured: 24months
antitumor activity2
To evaluate the antitumor activity of XKH002.disease control rate (DCR)
Measured: 24months
antitumor activity3
To evaluate the antitumor activity of XKH002. duration of overall response (DOR)
Measured: 24months
antitumor activity4
To evaluate the antitumor activity of XKH002.and progression-free survival (PFS)
Measured: 24months
antitumor activity5
To evaluate the antitumor activity of XKH002.according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
Measured: 24months
immunogenicity
To evaluate the immunogenicity of XKH002.Detection of antidrug antibodies (ADA)
Measured: 24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start27 Nov 2023
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic Solid TumorsStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- 0.3mg/kg, 1.0mg/kg, 3.0mg/kg,10mg/kg，20mg/kg.
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Kanova Biopharmaceutical Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lin Shen, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06196762
- Sponsor's protocol ID
- XKH002-101
- Status last verified
- Oct 2023
- First submitted
- 10 Nov 2023
- Last updated
- 10 Oct 2024
- 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 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-human (FIH),Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of XKH002 in Patients With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06196762
- Acronym / sponsor ID
- XKH002-101
- Conditions
- Advanced or Metastatic Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Zhejiang Kanova Biopharmaceutical Co., LTDIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 9 Jan 2024 (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 1, first-in-human (FIH), open-label, multicenter, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of XKH002 in patients with advanced or metastatic solid tumors.
Detailed description
Overall Study Design:
This is a Phase 1, first-in-human (FIH), open-label, multicenter, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of XKH002 in patients with advanced or metastatic solid tumors.
The study will include 2 parts, dose escalation and dose expansion
Part 1: Dose Escalation Based on the results of previous non-clinical efficacy and toxicology experiments and the prediction of human PK, the initial dose was set at 0.3 mg/kg, and the dose was increased according to 5 dose groups: The 0.3, 1.0, 3.0, 10,20 mg/kg dose-escalation phase will include accelerated titration and a traditional 3+3 dose-escalation design, with 16-30 participants expected to participate in the study.
The MTD or MAD will be identified, and all the available PK, PD, tolerability and activity in addition to safety data will be evaluated to select the recommended dose for expansion (RDE).
Part 2: Dose Expansion Based on the results of the dose-escalation trial (safety/tolerability, initial efficacy, PK/PD, etc.), it is expected that 20 to 80 participants will be enrolled in the study by RDE dose expansion of monotherapy for selected subjects of 1 to 4 tumor types.
Number of Participants:
Approximately 16 to 30 patients will be enrolled in Part 1 (dose escalation). Approximately 20 to 80 patients will be enrolled in Part 2 (dose expansion).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 0.3mg/kg, 1.0mg/kg, 3.0mg/kg,10mg/kg，20mg/kg.
| Arm | Type | Receives |
|---|---|---|
| XKH002 | Experimental | Drug: XKH002 InjectionA total of 5 dose cohorts will be enrolled and treated: 0.3, 1.0, 3.0, 10, and 20 mg/kg. The dose-escalation process will utilize both the accelerated titration and the conventional 3+3 methods. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Age 18 years or older;
- Life expectancy at least 3 months.
- Histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumor. Patient has had disease progression on one or more standard treatment regimens, or could not tolerate the treatment, or has no available treatment options.
- 4 The physical status score of "Eastern Cancer Collaboration Group (ECOG)" (see Appendix 5) was 0-1;
- 5 According to RECIST v1.1, all patients must have at least one evaluable lesion at baseline.
Key exclusion criteria (40 listed)
- Current or past autoimmune diseases or immunodeficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener's granuloma, Sjogren's syndrome, Guillain-Barre syndrome, or multiple sclerosis, with the following exceptions (see Appendix 4) :
- Patients with autoimmune related hypothyroidism who only need thyroid hormone replacement therapy are eligible to participate in the study;
- Patients with type 1 diabetes who receive insulin therapy for stable control are eligible to participate in the study;
- Patients with only dermatologic clinical manifestations of eczema, psoriasis, chronic lichen simple or vitiligo (e.g., excluding psoriatic arthritis) are eligible to participate in the study if they meet all of the following criteria:
- The skin rash area must be < 10% of the body surface area;
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 |
|---|---|---|
| XKH002 InjectionAlso: XKH002240 mg/4 mL/vial（60 mg/mL） | Drug | XKH002 |
Primary outcome
maximum tolerated dose (MTD) or the maximum administered dose (MAD) and the recommended dose for expansion (RDE)
Time frame: 24months
To determine the maximum tolerated dose (MTD) or the maximum administered dose (MAD) and the recommended dose for expansion (RDE) of XKH002 in patients with advanced solid tumors
safety and tolerability
Time frame: 24months
Incidence of treatment emergent adverse events (TEAEs), abnormal clinical laboratory tests, vital signs, electrocardiogram (ECG), and physical examination
12 secondary outcomes
pharmacokinetic (PK) parameters1
Time frame: 24months
pharmacokinetic (PK) parameters2
Time frame: 24months
pharmacokinetic (PK) parameters3
Time frame: 24months
pharmacokinetic (PK) parameters4
Time frame: 24months
pharmacokinetic (PK) parameters5
Time frame: 24months
pharmacokinetic (PK) parameters6
Time frame: 24months
antitumor activity1
Time frame: 24months
antitumor activity2
Time frame: 24months
antitumor activity3
Time frame: 24months
antitumor activity4
Time frame: 24months
antitumor activity5
Time frame: 24months
immunogenicity
Time frame: 24months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 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.
Lin Shen principal investigator
Peking University Cancer Hospital & Institute
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 XKH002 Injection in people with Advanced or Metastatic Solid Tumors, run by Zhejiang Kanova Biopharmaceutical 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 22 inclusion and 40 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: status not confirmed, as of the sponsor's last update on 10 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianguo You, MHA (010-82176552, jianguo.you@kanovabiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximum tolerated dose (MTD) or the maximum administered dose (MAD) and the recommended dose for expansion (RDE) (time frame: 24months). 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 10 Oct 2024.