Locally Advanced Solid TumorPhase 1/2NCT05028478
A Study of CN202 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors or Hematologic Malignancies
A Phase 1/2 study testing CN202 in people with Locally Advanced Solid Tumor and Metastatic Solid Tumor, run by Curon Biopharmaceutical (Australia) Co Pty Ltd.
Trial summary
The study is designed to evaluate the safety, tolerability, pharmacokinetic characteristics and anti-tumor activity of CN202 in adult subjects with locally advanced or metastatic solid tumor or hematologic malignancies Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Solid Tumor, Metastatic Solid Tumor, Hematologic Malignancies
- What is being tested?
- CN202
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- No sites listed yet
- Study dates
- 22 Oct 2021to 6 Oct 2023
- Phase
- Phase 1/2
- 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
- Subjects ≥ age of 18 on the day of signing informed consent;
- Histologically or cytologically diagnosed metastatic or locally advanced solid tumor or hematologic malignancy (unresectable), for whom no effective standard anti-tumor therapy existed or in the opinion of the Investigator have been considered ineligible for standard anti-tumor therapy at this stage, or are intolerant to standard anti-tumor therapy, or standard therapy had failed or the subject has refused standard anti-tumor therapy, or recurrent and progressing since last line anti-tumor therapy;
- Representative tumor specimens in paraffin blocks (preferred) or at least 10 unstained slides, with an associated pathology report, requested at any time prior to study entry. Only tissue from core needle, punch, or excisional biopsy sample collection will be accepted. If archival tissue is insufficient or unavailable, the subjects may still be eligible upon discussion with Medical Monitor and approved by sponsor.
- At least 1evaluable tumor lesion per RECIST v1.1 (Solid Tumors) and Lugano 2014 Criteria (Lymphoma). Disease-specific criteria will be used for prostate cancer and or other tumors. The subjects enrolled in phase Ib/II study must have measurable disease.
- Subjects with Eastern Cooperative Oncology Group (ECOG) performance score of 0 to1;
- At least 3 months of expected survival;
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- Female subjects must be non-pregnant and non-lactating, and must use an acceptable, highly effective double contraception method from Screening until the end of the Safety Follow-up period, 90 (±7 days) days after the last dose of the study drug. Double contraception is defined as a condom AND one other from of the following:
- Established hormonal contraception (with approved OCPs, long-acting implantable hormones, injectable hormones);
- A vaginal ring or an intrauterine device (IUD);
- Documented evidence of surgical sterilization at least 6 months prior to screening (eg, tubal occlusion, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy for women or vasectomy for men [with appropriate post-vasectomy documentation of the absence of sperm in semen] provided the male partner is a sole partner).
- Women not of childbearing potential must be post-menopausal for ≥12 months. Post-menopausal status will be confirmed through testing of follicle-stimulating hormone (FSH) levels ≥ 40 IU/L at Screening for amenorrhoeic female participants. Females who are abstinent from heterosexual intercourse will also be eligible.
- Periodic abstinence (eg, calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are not considered highly effective methods of birth control. Participant complete abstinence for the duration of the study and for 1 month after the last study treatment is acceptable.
- Female participants who are in same-sex relationships are not required to use contraception.
- Male subjects willing to use a highly effective method of contraception throughout the study period and for 90 days after the last dose of study drug.
- Subjects must be able to understand and sign the paper informed consent before any study specific procedure.
Who cannot join
- Received anti-tumor therapy, including radiotherapy, chemotherapy, hormonal therapy, immunotherapy, within 3 weeks prior to initiation of study treatment, however, the following are allowed:
- Palliative radiation therapy > 2 weeks.
- Small molecule targeted therapy > 2 weeks. But subject who has had anti-EGFR or anti-TKI (egerlotinib, gefitinib, afatinib, or crizotinib) > 1 week prior to the first dose of study therapy.
- Use of immunomodulatory drugs > 14 days or 5 half-lives of the drug prior to the first dose of study drug (whichever is shorter), including but not limited to thymosin, interleukin-2 (IL-2), interferon (IFN), etc.
- Herbal therapy > 1 week.
- Hormone-replacement therapy or oral contraceptives.
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- Hormonal therapy with gonadotropin-releasing hormone (GnRH) agonists or antagonists for prostate cancer.
- The subjects had prior treatment with anti-PD-L1 or anti-PD-1 therapeutic antibody, with the following exceptions:
- The subjects can be enrolled in Phase Ia study if no history of severe immune-related adverse effects from checkpoint inhibitor treatment or any that has led to discontinuation (CTCAE Grade 3 and 4).
- The subjects may be enrolled in Phase Ib/II study if the following requirements are met:
- > 6 weeks from the last dose of anti-PD-L1 or anti-PD-1 therapeutic antibody
- No history of severe immune-related adverse effects from checkpoint inhibitor treatment or any that has led to discontinuation (CTCAE Grade 3 and 4).
- at least 3 months on PD1 with evidence of benefit or stable disease as per investigator' judgment.
- Subjects who have received prior treatment with anti-CTLA-4 may be enrolled, provided the following requirements are met:
- > 6 weeks from the last dose of anti-CTLA-4
- No history of severe immune-related adverse effects from anti-CTLA-4 (CTCAE Grade 3 and 4)
- Received other investigational agents (not yet approved by any regulatory agency) within 4 weeks prior to the first dose of study drug;
- Major organ surgery (excluding puncture biopsy) or significant trauma within 4 weeks prior to the first dose of study drug, or elective surgery during the trial;
- Systemic application of corticosteroids (prednisone > 10 mg/day or equivalent) or other immunosuppressive agents within 14 days prior to the first dose of study drug;
- Exceptions: topical, ocular, intra-articular, intranasal, inhaled corticosteroids, or short-term corticosteroids for prophylaxis (eg, contrast allergy prophylaxis).
- Use of live attenuated vaccine within 4 weeks prior to the first dose of study drug;
- Exception: Approved COVID-19 vaccine is allowed, but the last dose of COVID-19 vaccine should be administered 2 weeks prior to first dose of study drug;
- For active subjects enrolled in this study, COVID-19 vaccination is allowed after 8 weeks treatment have been completed and the safety data have been obtained to make conclusion regarding the safety of the investigational product.
- Adverse reactions prior to anti-tumor therapy that have not recovered to ≤ Grade 1 assessed by CTCAE Version 5.0 (except for toxicities such as alopecia judged by the Investigator as no safety risk);
- Clinically symptomatic metastases to the central nervous system (CNS) or meninges, or other evidence of uncontrolled metastases to the CNS or meninges of the subject, judged by the Investigator. Subjects are eligible if metastases have been treated, subjects are neurologically stable for at least four weeks and not requiring steroid therapy for at least one week prior to Cycle 1 Day 1.
- Active infection and in current need of, or likely to need, intravenous anti-infective therapy;
- History of immunodeficiency, including history of any positive test result for human immunodeficiency virus (HIV) antibody;
- Active hepatitis B or hepatitis C infection: defined as having a positive hepatitis B surface antigen (HBsAg) test and/or detectable level of HBV DNA at Screening or hepatitis C infection defined as having a positive HCV antibody test followed by a positive HCV RNA test at Screening. HCV negative subjects are allowed to enrol. But in Phase Ib/II, the subjects with HBsAg+ but HBV DNA negative are allowed to be enrolled in HCC cohort with the use of antiviral therapy;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An Open-Label, Multi-center, Phase I/II Study of CN202 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors or Hematologic Malignancies
The study is designed to evaluate the safety, tolerability, pharmacokinetic characteristics and anti-tumor activity of CN202 in adult subjects with locally advanced or metastatic solid tumor or hematologic malignancies
Read the detailed description
This is a multi-centre, open-label, Phase I/II study in adult subjects with locally advanced or metastatic solid tumor or hematologic malignancies.
The study consists of three parts
Phase Ia: Dose Escalation: This is a dose escalation for assessment of dose-limiting toxicities (DLT) at approximately four dose levels in subjects with locally advanced or metastatic solid tumor or hematologic malignancies.
Phase Ib: Dose Expansion: To evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of CN202, prior to determination of Maximum tolerated dose (MTD)
Phase II: To further evaluate the safety, tolerance, pharmacokinetic characteristics, and anti-tumor activity of CN202 in subjects with select tumors. All subjects will receive the recommended Phase II dose of CN202.
There will be 13 to 24 subjects enrolled in phase Ia, 12 to 40 subjects in phase Ib and 15 to 100 subjects in phase II
- Being tested
- CN202
- Medical subject headings
- Neoplasm Metastasis, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CN202Drug
Participants will receive CN202 by IV infusion on Day 1 of each cycle (once every 2 weeks). The 4 planned dose levels are 1 mg/kg, 3 mg/kg, 10 mg/kg, 20 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Four planned CN202 dose level of 1 mg/kg, 3 mg/kg, 10 mg/kg, 20 mg/kg
Subjects will receive CN202 by intravenous infusion (IV) on Day 1 of each cycle (once every 2 weeks) for up to 24 months Receives: Drug: CN202 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of CN202 administered to subjects with locally advanced or metastatic solid tumor or hematologic malignancies through adverse events as assessed by NCI-CTCAE v5.0
Number of participants with treatment related adverse events as assessed by NCI-CTCAE v5.0
Measured: Measurements at Baseline till 90 days after the last dose of study drug
To evaluate the dose-limiting toxicity (DLT) and to determine the maximum tolerated dose (MTD) of CN202 when administered as a single-agent to subjects
Measured by Incidence of dose limiting toxicities (DLT) during the first cycle of treatment and DLT observation period
Measured: DLT assessed within 21 days after the first dose of CN202
To identify a recommended Phase II dose (RP2D) of CN202
The recommended Phase II dose (RP2D) will be determined based on safety, efficacy, pharmacokinetics and pharmacodynamic date of CN202
Measured: Baseline to End of the Treatment assessed up to an average of 24 months
To evaluate the anti-tumor activity of CN202 in selected solid tumors or hematologic malignancies as determined by Objective Response Rate (ORR)
Measured/determined by Objective Response Rate
Measured: Baseline to End of the Treatment assessed up to an average of 24 months
Secondary outcomes (10)
To evaluate the safety and tolerability of CN202 administered to subjects with locally advanced or metastatic solid tumor or hematologic malignancies through Electrocardiogram (ECG)
Measured by ECG as assessed by the P wave, the QRS complex, and T wave
Measured: Baseline to End of the Treatment assessed up to an average of 24 months
To evaluate the safety and tolerability of CN202 administered to subjects with locally advanced or metastatic solid tumor or hematologic malignancies through vital signs as assessed by heart rate
Measured: Baseline to End of the Treatment assessed up to an average of 24 months
To evaluate the safety and tolerability of CN202 administered to subjects with locally advanced or metastatic solid tumor or hematologic malignancies through vital signs as assessed by body temperature
Measured: Baseline to End of the Treatment assessed up to an average of 24 months
To evaluate the safety and tolerability of CN202 administered to subjects with locally advanced or metastatic solid tumor or hematologic malignancies through vital signs as assessed by pulse, systolic blood pressure, and diastolic blood pressure
Measured: Baseline to End of the Treatment assessed up to an average of 24 months
To evaluate the safety and tolerability of CN202 administered to subjects with locally advanced or metastatic solid tumor or hematologic malignancies through vital signs as assessed by respiratory rate
Measured: Baseline to End of the Treatment assessed up to an average of 24 months
To evaluate the pharmacokinetic (PK) of CN202 when administered to subjects with locally advanced or metastatic solid tumor or hematologic malignancies
The following parameter is used for evaluation during PK assessments: maximum concentration (Cmax)
Measured: Baseline to End of the Treatment assessed up to an average of 24 months
To evaluate the pharmacokinetic (PK) of CN202 when administered to subjects with locally advanced or metastatic solid tumor or hematologic malignancies
The following parameter is used for evaluation during PK assessments: area under the concentration-time curve (AUC)
Measured: Baseline to End of the Treatment assessed up to an average of 24 months
To evaluate the pharmacokinetic (PK) of CN202 when administered to subjects with locally advanced or metastatic solid tumor or hematologic malignancies
The following parameter is used for evaluation during PK assessments: half-life (t½)
Measured: Baseline to End of the Treatment assessed up to an average of 24 months
To assess the immunogenic potential of CN202 by measuring anti-CN202 antibodies through Immunogenicity analysis test results
Measured through immunogenicity analysis test results (anti-drug antibodies and Neutralizing antibodies) and days from first dosing to positive result of anti-drug antibodies (ADA) or Neutralizing antibodies (NAb)
Measured: Baseline to End of the Treatment assessed up to an average of 24 months
To assess the pharmacodynamic (PD) of CN202 when administered to subjects with locally advanced or metastatic solid tumor or hematologic malignancies
The pharmacodynamic profile assessed based on the analysis of PD-L1 receptor occupancy (RO) and biomarkers in peripheral blood and tumor tissues
Measured: Baseline to End of the Treatment assessed up to an average of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start22 Oct 2021 (estimated)
- Primary completion10 Feb 2023 (estimated)
- Study completion6 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Curon Biopharmaceutical (Australia) Co Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Responsible party
- Sponsor
- Investigators
- Gary Richardson, Principal investigator, Cabrini Oncology ResearchMorteza Aghmesheh, Principal investigator, Southern Medical Day Care Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05028478
- Sponsor's protocol ID
- CN202-102
- Status last verified
- Aug 2021
- First submitted
- 25 Aug 2021
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-center, Phase I/II Study of CN202 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors or Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT05028478
- Acronym / sponsor ID
- CN202-102
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Curon Biopharmaceutical (Australia) Co Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Study start
- 22 Oct 2021 (estimated)
- Primary completion
- 10 Feb 2023 (estimated)
- Study completion
- 6 Oct 2023 (estimated)
- First posted
- 31 Aug 2021 (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 study is designed to evaluate the safety, tolerability, pharmacokinetic characteristics and anti-tumor activity of CN202 in adult subjects with locally advanced or metastatic solid tumor or hematologic malignancies
Detailed description
This is a multi-centre, open-label, Phase I/II study in adult subjects with locally advanced or metastatic solid tumor or hematologic malignancies.
The study consists of three parts
Phase Ia: Dose Escalation: This is a dose escalation for assessment of dose-limiting toxicities (DLT) at approximately four dose levels in subjects with locally advanced or metastatic solid tumor or hematologic malignancies.
Phase Ib: Dose Expansion: To evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of CN202, prior to determination of Maximum tolerated dose (MTD)
Phase II: To further evaluate the safety, tolerance, pharmacokinetic characteristics, and anti-tumor activity of CN202 in subjects with select tumors. All subjects will receive the recommended Phase II dose of CN202.
There will be 13 to 24 subjects enrolled in phase Ia, 12 to 40 subjects in phase Ib and 15 to 100 subjects in phase II
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: CN202Four planned CN202 dose level of 1 mg/kg, 3 mg/kg, 10 mg/kg, 20 mg/kg Subjects will receive CN202 by intravenous infusion (IV) on Day 1 of each cycle (once every 2 weeks) for up to 24 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Subjects ≥ age of 18 on the day of signing informed consent;
- Histologically or cytologically diagnosed metastatic or locally advanced solid tumor or hematologic malignancy (unresectable), for whom no effective standard anti-tumor therapy existed or in the opinion of the Investigator have been considered ineligible for standard anti-tumor therapy at this stage, or are intolerant to standard anti-tumor therapy, or standard therapy had failed or the subject has refused standard anti-tumor therapy, or recurrent and progressing since last line anti-tumor therapy;
- Representative tumor specimens in paraffin blocks (preferred) or at least 10 unstained slides, with an associated pathology report, requested at any time prior to study entry. Only tissue from core needle, punch, or excisional biopsy sample collection will be accepted. If archival tissue is insufficient or unavailable, the subjects may still be eligible upon discussion with Medical Monitor and approved by sponsor.
- At least 1evaluable tumor lesion per RECIST v1.1 (Solid Tumors) and Lugano 2014 Criteria (Lymphoma). Disease-specific criteria will be used for prostate cancer and or other tumors. The subjects enrolled in phase Ib/II study must have measurable disease.
- Subjects with Eastern Cooperative Oncology Group (ECOG) performance score of 0 to1;
Key exclusion criteria (28 listed)
- Received anti-tumor therapy, including radiotherapy, chemotherapy, hormonal therapy, immunotherapy, within 3 weeks prior to initiation of study treatment, however, the following are allowed:
- The subjects had prior treatment with anti-PD-L1 or anti-PD-1 therapeutic antibody, with the following exceptions:
- Subjects who have received prior treatment with anti-CTLA-4 may be enrolled, provided the following requirements are met:
- Received other investigational agents (not yet approved by any regulatory agency) within 4 weeks prior to the first dose of study drug;
- Major organ surgery (excluding puncture biopsy) or significant trauma within 4 weeks prior to the first dose of study drug, or elective surgery during the trial;
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 |
|---|---|---|
| CN202Participants will receive CN202 by IV infusion on Day 1 of each cycle (once every 2 weeks). The 4 planned dose levels are 1 mg/kg, 3 mg/kg, 10 mg/kg, 20 mg/kg | Drug | Single Arm |
Primary outcome
To evaluate the safety and tolerability of CN202 administered to subjects with locally advanced or metastatic solid tumor or hematologic malignancies through adverse events as assessed by NCI-CTCAE v5.0
Time frame: Measurements at Baseline till 90 days after the last dose of study drug
Number of participants with treatment related adverse events as assessed by NCI-CTCAE v5.0
To evaluate the dose-limiting toxicity (DLT) and to determine the maximum tolerated dose (MTD) of CN202 when administered as a single-agent to subjects
Time frame: DLT assessed within 21 days after the first dose of CN202
Measured by Incidence of dose limiting toxicities (DLT) during the first cycle of treatment and DLT observation period
To identify a recommended Phase II dose (RP2D) of CN202
Time frame: Baseline to End of the Treatment assessed up to an average of 24 months
The recommended Phase II dose (RP2D) will be determined based on safety, efficacy, pharmacokinetics and pharmacodynamic date of CN202
To evaluate the anti-tumor activity of CN202 in selected solid tumors or hematologic malignancies as determined by Objective Response Rate (ORR)
Time frame: Baseline to End of the Treatment assessed up to an average of 24 months
Measured/determined by Objective Response Rate
10 secondary outcomes
To evaluate the safety and tolerability of CN202 administered to subjects with locally advanced or metastatic solid tumor or hematologic malignancies through Electrocardiogram (ECG)
Time frame: Baseline to End of the Treatment assessed up to an average of 24 months
To evaluate the safety and tolerability of CN202 administered to subjects with locally advanced or metastatic solid tumor or hematologic malignancies through vital signs as assessed by heart rate
Time frame: Baseline to End of the Treatment assessed up to an average of 24 months
To evaluate the safety and tolerability of CN202 administered to subjects with locally advanced or metastatic solid tumor or hematologic malignancies through vital signs as assessed by body temperature
Time frame: Baseline to End of the Treatment assessed up to an average of 24 months
To evaluate the safety and tolerability of CN202 administered to subjects with locally advanced or metastatic solid tumor or hematologic malignancies through vital signs as assessed by pulse, systolic blood pressure, and diastolic blood pressure
Time frame: Baseline to End of the Treatment assessed up to an average of 24 months
To evaluate the safety and tolerability of CN202 administered to subjects with locally advanced or metastatic solid tumor or hematologic malignancies through vital signs as assessed by respiratory rate
Time frame: Baseline to End of the Treatment assessed up to an average of 24 months
To evaluate the pharmacokinetic (PK) of CN202 when administered to subjects with locally advanced or metastatic solid tumor or hematologic malignancies
Time frame: Baseline to End of the Treatment assessed up to an average of 24 months
To evaluate the pharmacokinetic (PK) of CN202 when administered to subjects with locally advanced or metastatic solid tumor or hematologic malignancies
Time frame: Baseline to End of the Treatment assessed up to an average of 24 months
To evaluate the pharmacokinetic (PK) of CN202 when administered to subjects with locally advanced or metastatic solid tumor or hematologic malignancies
Time frame: Baseline to End of the Treatment assessed up to an average of 24 months
To assess the immunogenic potential of CN202 by measuring anti-CN202 antibodies through Immunogenicity analysis test results
Time frame: Baseline to End of the Treatment assessed up to an average of 24 months
To assess the pharmacodynamic (PD) of CN202 when administered to subjects with locally advanced or metastatic solid tumor or hematologic malignancies
Time frame: Baseline to End of the Treatment assessed up to an average of 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
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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.
Gary Richardson principal investigator
Cabrini Oncology Research
Morteza Aghmesheh principal investigator
Southern Medical Day Care Centre
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CN202 in people with Locally Advanced Solid Tumor and Metastatic Solid Tumor, run by Curon Biopharmaceutical (Australia) Co Pty 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 15 inclusion and 28 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 31 Aug 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Danny Zhu (+86 138-1074-9637, danming.zhu@curonbiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of CN202 administered to subjects with locally advanced or metastatic solid tumor or hematologic malignancies through adverse events as assessed by NCI-CTCAE v5.0 (time frame: Measurements at Baseline till 90 days after the last dose of study drug). The study lists 4 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 31 Aug 2021.