Solid TumorPhase 1NCT05230290
Clinical Study of KD6001 in Advanced Solid Tumours
A Phase 1 study testing KD6001 Injection in people with Solid Tumor, run by Shanghai Kanda Biotechnology Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety, tolerability and clinical activity of KD6001 as treatment for participants with advanced solid tumours. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- KD6001 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2020to 26 Jul 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being voluntary to sign the informed consent form.
- Age ≥ 18 and ≤ 70 years at the time of signing informed consent form, male or female.
- Life expectancy of at least 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1.
- Patients with histologically or cytologically confirmed advanced solid tumors: patients with advanced solid tumors who have failure in standard of care, cannot tolerate standard of care, refuse and/or have no standard of care (melanoma, renal carcinoma and urothelial carcinoma).
- Patients with at least one measurable lesion at baseline according to RECIST (Version 1.1).
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- Agree to provide tumor tissue specimen (fresh biopsied sample before treatment should be provided as far as possible, the archived sample within two years is acceptable for the patients who cannot provide fresh biopsied sample before treatment).
- Adequate organ function as indicated by the laboratory results during the screening period.
- Use of highly-effective contraceptive methods during the whole study for men of reproduction ability or women of pregnant possibility (e.g. oral contraceptives, intrauterine contraceptive device or barrier contraception in combination with spermatocide), and continuation of contraception for 6 months after the end of study treatment.
- Good compliance, cooperation with follow-up.
Who cannot join
- Subjects with history of other malignant tumors within the five years prior to study entry. Except for the malignant tumors that can be expected to be cured after treatment (including treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated by radical surgery).
- Have been previously exposed to any anti-tumor treatment, or local anti-tumor treatment, or received investigational drug or instrument therapy.
- Having received immunotherapy within 8 weeks prior to first dose of study drug (including antibody therapy and cell therapy); Subjects with prior anti-CTLA-4 checkpoint inhibitors should be excluded.
- Adverse reaction induced by previous therapy having not recovered to CTCAE (version 5.0) grade 1 or better (except alopecia and neurotoxicity, which is determined by investigators that long-term presence could not be restored).
- History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Having central nervous system metastases and/or cancerous meningitis.
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- Subjects with previously treated brain metastases may participate.
- Having or suspected to have active autoimmune disease.
- Patients with severe hepatitis and liver cirrhosis.
- Massive hydrothorax or ascites with clinical symptoms or requiring symptomatic treatment; Having serious cardiovascular diseases, pulmonary diseases, interstitial pneumonia, chronic obstructive pulmonary disease, and symptomatic bronchospasm heart disease; Having active infection requiring systemic treatment; Positive test for HIV or AIDS; chronic active HBV or HCV; Patients with active tuberculosis.
- Systemic glucocorticoids (prednisone > 10 mg / day or other glucocorticoids of equivalent dose) and other immuno-suppressive drugs were used within 14 days before the first study drug treatment; Use of broad-spectrum antibiotics that may affect the change of intestinal flora within 14 days prior to the first dose of study drug.
- Vaccination of live vaccine within 4 weeks prior to the start of study; Having received major surgery within 4 weeks prior to the first dose of study drug; History of anti-psychotics abuse and unable to abstain, or with a history of mental disorder.
- Pregnant or breastfeeding women.
- Allergy to KD6001 or its excipients.
- Other severe, acute or chronic medical diseases or abnormalities in laboratory examination possibly increasing the relevant risk in study participation or possibly interfering the interpretation of study results as judged by the investigators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Safety, Tolerability, and Pharmacokinetics of KD6001 in Patients With Advanced Solid Tumours - Phase I Clinical Study
The purpose of this study is to evaluate the safety, tolerability and clinical activity of KD6001 as treatment for participants with advanced solid tumours.
- Conditions
- Solid Tumor
- Being tested
- KD6001 Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KD6001 InjectionBiological
Solution for intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| KD6001 Injection | Experimental | Participants will be administered KD6001 at an applicable dose as monotherapy Receives: Biological: KD6001 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Dose Limiting Toxicities (DLTs)
DLTs will be assessed during the dose-escalation phase and are defined as toxicities.
Measured: Up to Day 28
Incidence and nature of participants with adverse events (AEs)
Evaluate the adverse events (AE) according to NCI CTCAE 5.0.
Measured: Baseline until 30 days after last dose of KD6001
To determine the Maximum tolerated dose (MTD)/Recommended Phase II dose (RP2D) of KD6001 in subjects with solid tumors
If more than or equal to one third of the participants at a dose level experience dose limiting toxicity (DLT), the MTD reassessed and the next lowest dose level for the combination therapy considered the MTD.
Measured: Baseline to study completion up to 2 years
Secondary outcomes (3)
Antitumor activity measured by Immune-Modified Response Evaluation Criteria in Solid Tumors (iRECIST)/Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Number of participants with response according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. Descriptive statistics and graphical analysis will be used to summarize patients' demographic and clinicopathological characteristics, patient safety and efficacy outcomes and correlative markers.
Measured: Baseline to study completion up to 2 years
To characterize the pharmacokinetics (PK) profile of KD6001: Maximum Observed Concentration (Cmax)
Serum concentrations of KD6001 in individual subjects at different time points after KD6001 administration
Measured: Baseline to study completion up to 2 years
To evaluate the immunogenicity of KD6001: Number of subjects who develop detectable anti-drug antibodies (ADAs)
The immunogenicity of KD6001 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs).
Measured: From baseline until 15 days after last dose of KD6001
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start10 Sep 2020
- Primary completion20 Jul 2022
- Study completion26 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Kanda Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jun Guo, MD, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05230290
- Sponsor's protocol ID
- KD6001CT01
- Status last verified
- Jan 2022
- First submitted
- 14 Jan 2022
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety, Tolerability, and Pharmacokinetics of KD6001 in Patients With Advanced Solid Tumours - Phase I Clinical Study
- ClinicalTrials.gov ID
- NCT05230290
- Acronym / sponsor ID
- KD6001CT01
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Shanghai Kanda Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 26 Jul 2022 (actual)
- First posted
- 8 Feb 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.
The purpose of this study is to evaluate the safety, tolerability and clinical activity of KD6001 as treatment for participants with advanced solid tumours.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KD6001 Injection | Experimental | Biological: KD6001 InjectionParticipants will be administered KD6001 at an applicable dose as monotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Being voluntary to sign the informed consent form.
- Age ≥ 18 and ≤ 70 years at the time of signing informed consent form, male or female.
- Life expectancy of at least 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1.
- Patients with histologically or cytologically confirmed advanced solid tumors: patients with advanced solid tumors who have failure in standard of care, cannot tolerate standard of care, refuse and/or have no standard of care (melanoma, renal carcinoma and urothelial carcinoma).
Key exclusion criteria (15 listed)
- Subjects with history of other malignant tumors within the five years prior to study entry. Except for the malignant tumors that can be expected to be cured after treatment (including treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated by radical surgery).
- Have been previously exposed to any anti-tumor treatment, or local anti-tumor treatment, or received investigational drug or instrument therapy.
- Having received immunotherapy within 8 weeks prior to first dose of study drug (including antibody therapy and cell therapy); Subjects with prior anti-CTLA-4 checkpoint inhibitors should be excluded.
- Adverse reaction induced by previous therapy having not recovered to CTCAE (version 5.0) grade 1 or better (except alopecia and neurotoxicity, which is determined by investigators that long-term presence could not be restored).
- History of allogeneic organ transplantation 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 |
|---|---|---|
| KD6001 InjectionSolution for intravenous injection | Biological | KD6001 Injection |
Primary outcome
Number of Participants with Dose Limiting Toxicities (DLTs)
Time frame: Up to Day 28
DLTs will be assessed during the dose-escalation phase and are defined as toxicities.
Incidence and nature of participants with adverse events (AEs)
Time frame: Baseline until 30 days after last dose of KD6001
Evaluate the adverse events (AE) according to NCI CTCAE 5.0.
To determine the Maximum tolerated dose (MTD)/Recommended Phase II dose (RP2D) of KD6001 in subjects with solid tumors
Time frame: Baseline to study completion up to 2 years
If more than or equal to one third of the participants at a dose level experience dose limiting toxicity (DLT), the MTD reassessed and the next lowest dose level for the combination therapy considered the MTD.
3 secondary outcomes
Antitumor activity measured by Immune-Modified Response Evaluation Criteria in Solid Tumors (iRECIST)/Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time frame: Baseline to study completion up to 2 years
To characterize the pharmacokinetics (PK) profile of KD6001: Maximum Observed Concentration (Cmax)
Time frame: Baseline to study completion up to 2 years
To evaluate the immunogenicity of KD6001: Number of subjects who develop detectable anti-drug antibodies (ADAs)
Time frame: From baseline until 15 days after last dose of KD6001
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 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. This study is not recruiting at the moment.
Jun Guo, MD 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 KD6001 Injection in people with Solid Tumor, run by Shanghai Kanda 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 10 inclusion and 15 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: finished, as of the sponsor's last update on 6 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Participants with Dose Limiting Toxicities (DLTs) (time frame: Up to Day 28). 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 6 Feb 2023; AzTrials last refreshed its copy on 1 Nov 2026.