Advanced Solid TumorPhase 1NCT05766527
A Study of KM602 in Patients With Advanced Solid Tumors
A Phase 1 study testing KM602 in people with Advanced Solid Tumor, run by Xuanzhu Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study is a Phase 1 open-label, first-in-human, multicenter study to evaluate the safety, tolerability, pharmacokinetics, and activity of KM602 as monotherapy in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- KM602
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- Apr 2023to Dec 2026
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed, disease that is unresectable, locally advanced, or metastatic and has progressed following all standard treatments or is not appropriate for standard treatments (predominantly melanoma and non-small cell lung cancer)
- All patients must have at least one measurable lesion at baseline according to RECIST v1.1
- ECOG performance status of 0 or 1
- Life expectancy of ≥ 12 weeks
- Adequate baseline hematologic, renal, and hepatic function
Who cannot join
- Patients with meningeal metastasis or symptomatic central nervous system metastasis
- Any second malignancy active within the previous 5 years
- Any active, known, or suspected autoimmune disease
- Active or prior pneumonitis or interstitial lung disease
- Prior organ allograft or allogeneic hematopoietic stem cell transplantation
- Treatment with any anti-cancer therapy or participation in another investigational drug or biologics trial within 4 weeks prior to the first dose of KM602
Show all 14Show fewer
- Prior treatment with a CTLA-4 antagonist, including ipilimumab and tremelimumab
- History of ≥ Grade 3 immune-related adverse event leading to treatment discontinuation
- Systemic treatment with corticosteroids (> 10 mg/day prednisone) or other immunosuppressive medication within 14 days prior to the first dose of KM602 or during the study
- Known seropositivity for or active infection by human immunodeficiency virus, hepatitis B or C
- Known allergies, hypersensitivity, or intolerance to KM602 or excipients in the drug product formulation
- Active infection requiring therapy at the time of the first dose of KM602
- Pregnancy or breastfeeding
- Any serious or uncontrolled health condition, which, in the opinion of the Investigator, would place the subject at undue risk from the study, impair the ability of the subject to receive protocol specified therapy, or interfere with the interpretation of study results.
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
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Jun Guo, 13911233048, guoj307@126.com
About this study
Official title: A Phase 1 Safety and Tolerability Study of KM602 in Patients With Advanced Solid Tumors
This study is a Phase 1 open-label, first-in-human, multicenter study to evaluate the safety, tolerability, pharmacokinetics, and activity of KM602 as monotherapy in patients with advanced solid tumors.
Read the detailed description
This Phase 1 study is comprised of dose escalation and expansions for KM602 monotherapy. Monotherapy dose escalation is designed with initial accelerated titration followed by a standard 3+3 dose escalation; Patients will remain on study treatment until progression of disease, unacceptable toxicity, or other specified reason for discontinuation.
- Conditions
- Advanced Solid Tumor
- Being tested
- KM602
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KM602Biological
Multiple dose levels of KM602 will be administered, including 0.01 mg/kg QW, 0.1 mg/kg QW, 0.6 mg/kg QW, 3 mg/kg QW, and 10 mg/kg QW. KM602 is administered intravenously once a week, and each cycle is 21 days.
| Study group | Role | What they receive |
|---|---|---|
| KM602 monotherapy | Experimental | Dose escalation and expansion Receives: Biological: KM602 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) of KM602, if any
Determined by the frequency of dose-limiting toxicities during dose-escalation
Measured: Approximately 15 months
Recommended Phase 2 dose (RP2D) of KM602
Determined by the frequency of dose-limiting toxicities during dose-escalation
Measured: Approximately 15 months
Incidence of treatment emergent adverse events
Severity graded per CTCAE version 5.0
Measured: Through study completion, approximately 28 months
Secondary outcomes (11)
Maximum Plasma Concentration (Cmax) of KM602
Measured: Through study completion, approximately 28 months
Area Under the Curve (AUC) of KM602
Measured: Through study completion, approximately 28 months
t1/2 of KM602
Measured: Through study completion, approximately 28 months
Plasma clearance (CL) of KM602
Measured: Through study completion, approximately 28 months
Volume of distribution (V) of KM602
Measured: Through study completion, approximately 28 months
Anti-Drug Antibody of KM602
Measured: Through study completion, approximately 28 months
Objective Response Rate (ORR) of KM602
Measured: Through study completion, approximately 28 months
Disease Control Rate (DCR) of KM602
Measured: Through study completion, approximately 28 months
Progression-free survival(PFS) of KM602
Measured: Through study completion, approximately 28 months
Duration of Response (DOR) of KM602
Measured: Through study completion, approximately 28 months
Overall survival (OS) of KM602
Measured: Through study completion, approximately 28 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study startApr 2023 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
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 Xuanzhu Biopharmaceutical Co., Ltd.The 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
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05766527
- Sponsor's protocol ID
- KM602-1001
- Status last verified
- Feb 2023
- First submitted
- 28 Feb 2023
- Last updated
- 13 Mar 2023
- 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 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Safety and Tolerability Study of KM602 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05766527
- Acronym / sponsor ID
- KM602-1001
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2023 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Mar 2023 (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 a Phase 1 open-label, first-in-human, multicenter study to evaluate the safety, tolerability, pharmacokinetics, and activity of KM602 as monotherapy in patients with advanced solid tumors.
Detailed description
This Phase 1 study is comprised of dose escalation and expansions for KM602 monotherapy. Monotherapy dose escalation is designed with initial accelerated titration followed by a standard 3+3 dose escalation; Patients will remain on study treatment until progression of disease, unacceptable toxicity, or other specified reason for discontinuation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KM602 monotherapy | Experimental | Biological: KM602Dose escalation and expansion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically confirmed, disease that is unresectable, locally advanced, or metastatic and has progressed following all standard treatments or is not appropriate for standard treatments (predominantly melanoma and non-small cell lung cancer)
- All patients must have at least one measurable lesion at baseline according to RECIST v1.1
- ECOG performance status of 0 or 1
- Life expectancy of ≥ 12 weeks
- Adequate baseline hematologic, renal, and hepatic function
Key exclusion criteria (14 listed)
- Patients with meningeal metastasis or symptomatic central nervous system metastasis
- Any second malignancy active within the previous 5 years
- Any active, known, or suspected autoimmune disease
- Active or prior pneumonitis or interstitial lung disease
- Prior organ allograft or allogeneic hematopoietic stem cell transplantation
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 |
|---|---|---|
| KM602Multiple dose levels of KM602 will be administered, including 0.01 mg/kg QW, 0.1 mg/kg QW, 0.6 mg/kg QW, 3 mg/kg QW, and 10 mg/kg QW. KM602 is administered intravenously once a week, and each cycle is 21 days. | Biological | KM602 monotherapy |
Primary outcome
Maximum tolerated dose (MTD) of KM602, if any
Time frame: Approximately 15 months
Determined by the frequency of dose-limiting toxicities during dose-escalation
Recommended Phase 2 dose (RP2D) of KM602
Time frame: Approximately 15 months
Determined by the frequency of dose-limiting toxicities during dose-escalation
Incidence of treatment emergent adverse events
Time frame: Through study completion, approximately 28 months
Severity graded per CTCAE version 5.0
11 secondary outcomes
Maximum Plasma Concentration (Cmax) of KM602
Time frame: Through study completion, approximately 28 months
Area Under the Curve (AUC) of KM602
Time frame: Through study completion, approximately 28 months
t1/2 of KM602
Time frame: Through study completion, approximately 28 months
Plasma clearance (CL) of KM602
Time frame: Through study completion, approximately 28 months
Volume of distribution (V) of KM602
Time frame: Through study completion, approximately 28 months
Anti-Drug Antibody of KM602
Time frame: Through study completion, approximately 28 months
Objective Response Rate (ORR) of KM602
Time frame: Through study completion, approximately 28 months
Disease Control Rate (DCR) of KM602
Time frame: Through study completion, approximately 28 months
Progression-free survival(PFS) of KM602
Time frame: Through study completion, approximately 28 months
Duration of Response (DOR) of KM602
Time frame: Through study completion, approximately 28 months
Overall survival (OS) of KM602
Time frame: Through study completion, approximately 28 months
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 13 Mar 2023.
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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.
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 KM602 in people with Advanced Solid Tumor, run by Xuanzhu 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 5 inclusion and 14 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: opening soon, as of the sponsor's last update on 13 Mar 2023. 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 Xingming Fan (086-18513114991, fanxingming@xuanzhubio.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) of KM602, if any (time frame: Approximately 15 months). 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 13 Mar 2023.