Advanced Solid TumorsPhase 1NCT05667194
Phase 1 Trial of KH617
A Phase 1 study testing KH617 in people with Advanced Solid Tumors, run by Sichuan Honghe Biotechnology Co., Ltd. at 1 site in China.
Trial summary
KH617 is a injection used for advanced solid tumors which must be diluted with 5% Dextrose Injection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- KH617
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 26 Dec 2022to Aug 2031
- Phase
- Phase 1
- 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
- 1.Signed and dated written informed consent in accordance with International Council for Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
- 2.Patient is male or female ≥18 years of age. 3.Patient must satisfy the following laboratory test results:
- a.Hemoglobin ≥9g/dL b.Platelet count ≥100×10^9/L c.Absolute neutrophil count≥1.5×10^9/L d.Albumin ≥3.0g/dL e.Total bilirubin ≤1.5×ULN f.Aspartate aminotransferase and alanine aminotransferase≤2.5×ULN g.Adequate renal function, defined as estimated serum creatinine clearance>50mL/minute calculated using the Cockcroft-Gault equation,urine protein<2+ or urine protein>2+ but 24-hour proteinuria<1g h.Prothrombin time, international normalized ratio, and activated partial thromboplastin time≤1.5×ULN (except for patients receiving anticoagulant therapy) 4.Patients who have fully recovered (defined as ≤grade 1 NCI-CTCAE 5.0) from all previous acute treatment-related toxic effects of previous cancer treatments prior to enrollment.
- 5.Life expectancy at least 3 months. 6.Specific Inclusion Criteria
- Advanced Solid Tumors
- Patients with histopathology and/or cytology diagnosed as unresectable, locally advanced or metastatic malignant solid tumors for which there is no further standard treatment or for which the patient is not tolerated.
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- Patient has at least one measurable or evaluable target lesion by RECIST 1.1.
- Patient has an ECOG status of 0 to 2.
- Brain Metastases
- Patient has at least one measurable or evaluable target lesion by RANO-BM.
- rGBM
- Patient with histopathology and/or cytology diagnosed advanced malignant adult diffuse glioma has unequivocal evidence of GBM recurrence/progression following completion of standard treatment.
- Patient has at measurable or evaluable target lesion by RANO.
- 4.Patient has a Karnofsky Performance score (KPS) ≥60.
Who cannot join
- 1.Patient has received extensive radiation therapy. 2.Patients has the following infectious diseases:
- a.Hepatitis B surface antigen-positive and HBV-DNA test indicated active hepatitis B b.Active hepatitis c. C. AIDS or HIV antibody test is positive. d.Uncontrolled active infection. 3. Patient has a positive blood beta-HCG pregnancy test 7 days before the first administration (only for female with bearing potential ), or male and female with bearing potential who are unwilling to use adequate contraception for the duration of the study, and for a minimum of6 months after last dose of KH617.
- 4. 11.Patient is currently pregnant or breastfeeding. 5. Patients with previous phrenoblabia history or currently phrenoblabia Including but not limited to schizophrenia, paranoia, phobias, obsessive-compulsive disorder, insomnia, Alzheimer's disease, behavioral volitional disorder, postpartum mental disorder, paranoid mental disorder, or organic psychosis.
- 6. Patient has had another malignancy within the previous 5 years. 7. Patient has active cardiac or cerebrovascular disease. 8.Patient has participated in another investigational study using an investigational or marketed drug or device within 28 days.
- 9. Patient has severe sensitivity/allergic reaction to KH617. 10.Patient has any other conditions that render them inappropriate for inclusion in the investigator's opinion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Titan Hospital,Capital Medical University
Beijing, Beijing Municipality, 100000
Wenbin Li, M.D.
About this study
Official title: A Phase 1 Study to Assess the Safety ,Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of KH617 After SAD and MAD Administration for Patients With Advanced Solid Tumors
KH617 is a injection used for advanced solid tumors which must be diluted with 5% Dextrose Injection.
- Conditions
- Advanced Solid Tumors
- Being tested
- KH617
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KH617Drug
KH617 is s freeze-dried powder injection
| Study group | Role | What they receive |
|---|---|---|
| KH617 dose 1 | Experimental | Three times (on days 1, 2, and 3) weekly for the first three consecutive weeks in a 28-day cycle Receives: Drug: KH617 |
| KH617 dose 2 | Experimental | Three times (on days 1, 2, and 3) weekly for the first three consecutive weeks in a 28-day cycle Receives: Drug: KH617 |
| KH617 dose 3 | Experimental | Three times (on days 1, 2, and 3) weekly for the first three consecutive weeks in a 28-day cycle Receives: Drug: KH617 |
| KH617 dose 4 | Experimental | Three times (on days 1, 2, and 3) weekly for the first three consecutive weeks in a 28-day cycle Receives: Drug: KH617 |
| KH617 dose 5 | Experimental | Three times (on days 1, 2, and 3) weekly for the first three consecutive weeks in a 28-day cycle Receives: Drug: KH617 |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD
Measured: 90 weeks
DLT
Measured: 90 weeks
RP2D
Measured: 154 weeks
Secondary outcomes (2)
ORR
Measured: 154 weeks
PFS
Measured: 154 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start26 Dec 2022
- Primary completionSep 2030 (estimated)
- Study completionAug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Honghe Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wenbin Li, Principal investigator, Beijing Titan Hospital,Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667194
- Sponsor's protocol ID
- KH617
- Status last verified
- Mar 2024
- First submitted
- 19 Dec 2022
- Last updated
- 27 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Assess the Safety ,Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of KH617 After SAD and MAD Administration for Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05667194
- Acronym / sponsor ID
- KH617
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Sichuan Honghe Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Dec 2022 (actual)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Aug 2031 (estimated)
- First posted
- 28 Dec 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.
KH617 is a injection used for advanced solid tumors which must be diluted with 5% Dextrose Injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| KH617 dose 1 | Experimental | Drug: KH617Three times (on days 1, 2, and 3) weekly for the first three consecutive weeks in a 28-day cycle |
| KH617 dose 2 | Experimental | Drug: KH617Three times (on days 1, 2, and 3) weekly for the first three consecutive weeks in a 28-day cycle |
| KH617 dose 3 | Experimental | Drug: KH617Three times (on days 1, 2, and 3) weekly for the first three consecutive weeks in a 28-day cycle |
| KH617 dose 4 | Experimental | Drug: KH617Three times (on days 1, 2, and 3) weekly for the first three consecutive weeks in a 28-day cycle |
| KH617 dose 5 | Experimental | Drug: KH617Three times (on days 1, 2, and 3) weekly for the first three consecutive weeks in a 28-day cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 1.Signed and dated written informed consent in accordance with International Council for Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
- 2.Patient is male or female ≥18 years of age. 3.Patient must satisfy the following laboratory test results:
- a.Hemoglobin ≥9g/dL b.Platelet count ≥100×10^9/L c.Absolute neutrophil count≥1.5×10^9/L d.Albumin ≥3.0g/dL e.Total bilirubin ≤1.5×ULN f.Aspartate aminotransferase and alanine aminotransferase≤2.5×ULN g.Adequate renal function, defined as estimated serum creatinine clearance>50mL/minute calculated using the Cockcroft-Gault equation,urine protein<2+ or urine protein>2+ but 24-hour proteinuria<1g h.Prothrombin time, international normalized ratio, and activated partial thromboplastin time≤1.5×ULN (except for patients receiving anticoagulant therapy) 4.Patients who have fully recovered (defined as ≤grade 1 NCI-CTCAE 5.0) from all previous acute treatment-related toxic effects of previous cancer treatments prior to enrollment.
- 5.Life expectancy at least 3 months. 6.Specific Inclusion Criteria
Key exclusion criteria (5 listed)
- 1.Patient has received extensive radiation therapy. 2.Patients has the following infectious diseases:
- a.Hepatitis B surface antigen-positive and HBV-DNA test indicated active hepatitis B b.Active hepatitis c. C. AIDS or HIV antibody test is positive. d.Uncontrolled active infection. 3. Patient has a positive blood beta-HCG pregnancy test 7 days before the first administration (only for female with bearing potential ), or male and female with bearing potential who are unwilling to use adequate contraception for the duration of the study, and for a minimum of6 months after last dose of KH617.
- 4. 11.Patient is currently pregnant or breastfeeding. 5. Patients with previous phrenoblabia history or currently phrenoblabia Including but not limited to schizophrenia, paranoia, phobias, obsessive-compulsive disorder, insomnia, Alzheimer's disease, behavioral volitional disorder, postpartum mental disorder, paranoid mental disorder, or organic psychosis.
- 6. Patient has had another malignancy within the previous 5 years. 7. Patient has active cardiac or cerebrovascular disease. 8.Patient has participated in another investigational study using an investigational or marketed drug or device within 28 days.
- 9. Patient has severe sensitivity/allergic reaction to KH617. 10.Patient has any other conditions that render them inappropriate for inclusion in the investigator's opinion.
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 |
|---|---|---|
| KH617KH617 is s freeze-dried powder injection | Drug | KH617 dose 1, KH617 dose 2, KH617 dose 3, KH617 dose 4, KH617 dose 5 |
Primary outcome
MTD
Time frame: 90 weeks
DLT
Time frame: 90 weeks
RP2D
Time frame: 154 weeks
2 secondary outcomes
ORR
Time frame: 154 weeks
PFS
Time frame: 154 weeks
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 27 Nov 2024.
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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.
Wenbin Li principal investigator
Beijing Titan Hospital,Capital Medical University
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 KH617 in people with Advanced Solid Tumors, run by Sichuan Honghe Biotechnology 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 14 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: looking for participants now, as of the sponsor's last update on 27 Nov 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?
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 Zhao Manxi (86 15882459305, zhaomanqian@cnkh.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD (time frame: 90 weeks). 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 27 Nov 2024.