Solid TumorsPhase 1/2NCT06928363
A First-in-human Study of KY-0301 in Patients With Advanced Solid Tumors.
A Phase 1/2 study testing KY-0301 in people with Solid Tumors, run by Novatim Immune Therapeutics (Zhejiang) Co., Ltd..
Trial summary
This trial is a first-in-human, multicenter, open-label Phase I/II clinical study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of KY-0301 as monotherapy in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- KY-0301
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 15 Dec 2027
- Phase
- Phase 1/2
- 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
- Know the trial information before the start of the study and voluntarily sign an informed consent form (ICF).
- Aged ≥ 18 years, male or female.
- Agree to follow and be capable of completing all study procedures.
- Female weight > 45 kg, male weight > 50 kg, with a BMI ≥18 kg/m2
- Tumor Types:
- Part I, Patients with histologically or cytologically confirmed locally advanced or metastatic solid tumors; Patients who have failed existing standard treatment regimens, are intolerant to standard treatment, have no standard treatment regimen, or are currently not suitable for standard treatment.
- Part II, Cohort A: Histologically or cytologically confirmed locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) ;Patients who have previously received EGFR TKI and at least 1st line platinum-containing two-drug standard systemic chemotherapy; Patients must have radiographically confirmed disease progression from the last prior anticancer therapy to the enrollment in this study. Cohort B: Histologically or cytologically confirmed NSCLC with no actionable genetic mutations have been identified ；have received at least first-line anti-PD - (L) 1 immunotherapy and chemotherapy . Cohort C :Histologically or cytologically confirmed CRC; Patients who have previously received SoC; chemotherapy above the 3rd line is received in the systemic treatment phase. Cohort D: other histologically or cytologically confirmed locally advanced or metastatic solid tumors
Who cannot join
- History of intolerance to ADC therapy composed of monomethyl auristatin E (MMAE).
- Inadequate washout period of prior antitumor therapy prior to the first dose
- Patients who have undergone major surgery (excluding diagnostic surgery) within 4 weeks prior to first dose or those who plan to undergo major surgery during the study period. Interventional or ablative procedures for tumor treatment within 2 weeks prior to the first dose of the investigational drug.
- Previous allogeneic bone marrow transplantation or previous solid organ transplantation.
- Systemic steroid use (>20 mg/day of prednisone or equivalent) or other immunosuppressive treatments within 2 weeks prior to first dose of the investigational drug, with the following exceptions: Intranasal, inhaled, or local steroid injections (e.g., intra-articular injections); Physiologic doses of systemic steroids as replacement therapy (e.g., physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency);Use of steroids to prevent hypersensitivity reactions or to prevent antiemetic (e.g., computed tomography (CT) prophylaxis).
- Received any live vaccine within 4 weeks prior to the first dose or plan to receive a live vaccine during the study.
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- History of leptomeningeal carcinomatosis or carcinomatous meningitis.
- Brain metastasis or spinal cord compression, except for Patients with asymptomatic brain metastases
- Uncontrolled or clinically significant cardiovascular or cerebrovascular diseases
- Clinically significant concomitant pulmonary diseases
- Patients with symptomatic or unstable third-spacing (e.g., pleural effusion, ascites, pericardial effusion) require repeated drainage.
- History of gastrointestinal perforation and/or fistula within 6 months prior to the first dose, or the presence of active gastric ulcer, duodenal ulcer, ulcerative colitis, gastrointestinal obstruction, or any other gastrointestinal disease that the investigator deems may cause bleeding or perforation.
- Patients with severe infection [≥ Grade 3 per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0] prior to first dose
- Patients with HIV infection or those who test positive for syphilis antibodies with a positive titer test.
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Active HBV is defined as positive hepatitis B surface antigen (HBsAg) and/or positive hepatitis B core antibody (HBcAb), with HBV DNA levels above the detectable lower limit of the study site; active HCV is defined as positive hepatitis C antibodies with HCV RNA levels above the detectable lower limit of the study site.
- Non remission of toxicity from previous anticancer therapy is defined as non remission of toxicity (other than alopecia and pigmentation) to NCI CTCAE v5.0 ≤ Grade 1, baseline, or inclusion/exclusion criteria. Patients with chronic Grade 2 toxicities may be eligible for enrollment if the toxicity is asymptomatic or adequately controlled with stable medication, after discussion with the sponsor.
- History of severe allergic reactions to drugs
- Any other primary malignancy within 5 years prior to first dose of the investigational drug, except for low-risk tumors such as adequately resected basal cell skin cancer, cervical carcinoma in situ, or papillary thyroid carcinoma .etc.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A First-in-human, Multicenter, Open-label Phase I/II Investigational Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of KY-0301 as Monotherapy in Patients With Advanced Solid Tumors.
This trial is a first-in-human, multicenter, open-label Phase I/II clinical study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of KY-0301 as monotherapy in patients with advanced solid tumors. This trial will be conducted at approximately multi-sites nationwide, and approximately110~212 participants with unresectable locally advanced or metastatic solid tumors will be invited to participate. The study consists of three parts: Phase I dose escalation \& dose expansion phases of KY-0301 as monotherapy, Phase II cohort expansion phase of KY-0301 as monotherapy.
- Conditions
- Solid Tumors
- Being tested
- KY-0301
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KY-0301Drug
KY-0301 is an antibody-drug conjugate (ADC) targeting both EGFR and c-Met, developed independently by Novatim Immune Therapeutics (Zhejiang) Co., Ltd
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation/Expansion：KY-0301 | Experimental | KY-0301, 0.3 mg/kg~ 2.0 mg/kg.i.v. Q2W，4 weeks/cycle Receives: Drug: KY-0301 |
| Cohort A:EGFRm NSCLC | Experimental | KY-0301, .i.v. Q2W，4 weeks/cycle Receives: Drug: KY-0301 |
| Cohort B:EGFRwt NSCLC | Experimental | KY-0301, 0.3 mg/kg~ 2.0 mg/kg.i.v. Q2W，4 weeks/cycle Receives: Drug: KY-0301 |
| Cohort C:CRC | Experimental | KY-0301, 0.3 mg/kg~ 2.0 mg/kg.i.v. Q2W，4 weeks/cycle Receives: Drug: KY-0301 |
| Cohort D: other solid tumor | Experimental | KY-0301, 0.3 mg/kg~ 2.0 mg/kg.i.v. Q2W，4 weeks/cycle Receives: Drug: KY-0301 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of dose-limiting toxicity (DLT)
DLT is defined as an adverse event (AE) that meets protocol defined DLT criteria during cycle 1 and is at least possibly related to study drug.
Measured: 28 days
MTD
The maximum tolerated dose (MTD) is defined as the maximum dose where the number of cases of DLT ≤ 1/6 of the total number of cases during the DLT observation period. At least 6 evaluable subjects are required to determine MTD.
Measured: Up to 24 Months
Secondary outcomes (5)
The area under curve (AUC) of KY-0301 (ADC) in plasma
Area under the plasma concentration versus time curve
Measured: Up to 24 Months
The immunogenicity of KY-0301
Occurrence of anti-drug antibodies (ADA)
Measured: Up to 24 Months
Objective response rate (ORR)
defined as percentage of participants with confirmed best overall response of confirmed partial response (PR) or better per investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: Up to 24 Months
Progression-free survival (PFS)
PFS is defined as time from first study treatment to a documented disease progression according to RECIST, version 1.1, as determined by the investigator, or death due to any cause, whichever occurs earlier.
Measured: Up to 24 Months
The maximum concentration (Cmax) of KY-0301 in plasma
The Peak Plasma Concentration of KY-0301 in plasma
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion12 Nov 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novatim Immune Therapeutics (Zhejiang) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06928363
- Sponsor's protocol ID
- KY-0301-XG101
- Status last verified
- Mar 2025
- First submitted
- 31 Mar 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human, Multicenter, Open-label Phase I/II Investigational Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of KY-0301 as Monotherapy in Patients With Advanced Solid Tumors.
- ClinicalTrials.gov ID
- NCT06928363
- Acronym / sponsor ID
- KY-0301-XG101
- Conditions
- Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Novatim Immune Therapeutics (Zhejiang) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 12 Nov 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 15 Apr 2025 (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 trial is a first-in-human, multicenter, open-label Phase I/II clinical study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of KY-0301 as monotherapy in patients with advanced solid tumors. This trial will be conducted at approximately multi-sites nationwide, and approximately110~212 participants with unresectable locally advanced or metastatic solid tumors will be invited to participate. The study consists of three parts: Phase I dose escalation \& dose expansion phases of KY-0301 as monotherapy, Phase II cohort expansion phase of KY-0301 as monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dose escalation/Expansion：KY-0301 | Experimental | Drug: KY-0301KY-0301, 0.3 mg/kg~ 2.0 mg/kg.i.v. Q2W，4 weeks/cycle |
| Cohort A:EGFRm NSCLC | Experimental | Drug: KY-0301KY-0301, .i.v. Q2W，4 weeks/cycle |
| Cohort B:EGFRwt NSCLC | Experimental | Drug: KY-0301KY-0301, 0.3 mg/kg~ 2.0 mg/kg.i.v. Q2W，4 weeks/cycle |
| Cohort C:CRC | Experimental | Drug: KY-0301KY-0301, 0.3 mg/kg~ 2.0 mg/kg.i.v. Q2W，4 weeks/cycle |
| Cohort D: other solid tumor | Experimental | Drug: KY-0301KY-0301, 0.3 mg/kg~ 2.0 mg/kg.i.v. Q2W，4 weeks/cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Know the trial information before the start of the study and voluntarily sign an informed consent form (ICF).
- Aged ≥ 18 years, male or female.
- Agree to follow and be capable of completing all study procedures.
- Female weight > 45 kg, male weight > 50 kg, with a BMI ≥18 kg/m2
- Tumor Types:
Key exclusion criteria (18 listed)
- History of intolerance to ADC therapy composed of monomethyl auristatin E (MMAE).
- Inadequate washout period of prior antitumor therapy prior to the first dose
- Patients who have undergone major surgery (excluding diagnostic surgery) within 4 weeks prior to first dose or those who plan to undergo major surgery during the study period. Interventional or ablative procedures for tumor treatment within 2 weeks prior to the first dose of the investigational drug.
- Previous allogeneic bone marrow transplantation or previous solid organ transplantation.
- Systemic steroid use (>20 mg/day of prednisone or equivalent) or other immunosuppressive treatments within 2 weeks prior to first dose of the investigational drug, with the following exceptions: Intranasal, inhaled, or local steroid injections (e.g., intra-articular injections); Physiologic doses of systemic steroids as replacement therapy (e.g., physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency);Use of steroids to prevent hypersensitivity reactions or to prevent antiemetic (e.g., computed tomography (CT) prophylaxis).
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 |
|---|---|---|
| KY-0301KY-0301 is an antibody-drug conjugate (ADC) targeting both EGFR and c-Met, developed independently by Novatim Immune Therapeutics (Zhejiang) Co., Ltd | Drug | Cohort A:EGFRm NSCLC, Cohort B:EGFRwt NSCLC, Cohort C:CRC, Cohort D: other solid tumor, Dose escalation/Expansion：KY-0301 |
Primary outcome
Occurrence of dose-limiting toxicity (DLT)
Time frame: 28 days
DLT is defined as an adverse event (AE) that meets protocol defined DLT criteria during cycle 1 and is at least possibly related to study drug.
MTD
Time frame: Up to 24 Months
The maximum tolerated dose (MTD) is defined as the maximum dose where the number of cases of DLT ≤ 1/6 of the total number of cases during the DLT observation period. At least 6 evaluable subjects are required to determine MTD.
5 secondary outcomes
The area under curve (AUC) of KY-0301 (ADC) in plasma
Time frame: Up to 24 Months
The immunogenicity of KY-0301
Time frame: Up to 24 Months
Objective response rate (ORR)
Time frame: Up to 24 Months
Progression-free survival (PFS)
Time frame: Up to 24 Months
The maximum concentration (Cmax) of KY-0301 in plasma
Time frame: up to 24 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 15 Apr 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing KY-0301 in people with Solid Tumors, run by Novatim Immune Therapeutics (Zhejiang) Co., Ltd..
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 7 inclusion and 18 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 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Caicun Zhou (Shanghai, China:13301825532, caicunzhoudr@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of dose-limiting toxicity (DLT) (time frame: 28 days). 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 15 Apr 2025.