Advanced Solid TumorPhase 1NCT04418141

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CN1

A Phase 1 study testing CN1 in people with Advanced Solid Tumor and B Cell Lymphoma, run by Curon Biopharmaceutical (Australia) Co Pty Ltd at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is the first-in-human clinical trial of CN1 to evaluate the safety, tolerability, pharmacokinetic (PK) profile and preliminary efficacy of CN1 in patients with advanced solid tumors or B-cell lymphoma. This study will provide a basis for further clinical development of CN1. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Advanced Solid Tumor, B Cell Lymphoma
What is being tested?: CN1
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 1 siteAustria
Study dates: 2 Jul 2020to 7 Oct 2021
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥ 18 years and ≤ 75 years old, male or female;
Subjects with histologically or cytologically diagnosed advanced malignant solid tumors or B-cell lymphoma who have failed on, or are intolerant to, standard therapy, for whom there are no standard of care regimens, or who are otherwise not eligible for standard therapy at this stage;
Subjects with Eastern Cooperative Oncology Group (ECOG) performance score of 0-1;
Females must be non-pregnant and non-lactating, and must use an acceptable, highly effective double contraception from screening until the end of the follow-up period.
Subjects must be able to understand and sign the paper informed consent before any study specific procedure.

Who cannot join

Received anti-tumor treatment such as radiotherapy, chemotherapy, biotherapy, endocrine therapy, immunotherapy, etc., within 4 weeks prior to the first dose of study drug.
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;
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, and inhaled corticosteroids, or short-term corticosteroids for prophylaxis (e.g., contrast allergy prophylaxis).
Use of live attenuated vaccine within 4 weeks prior to the first dose of study drug;

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Clinically symptomatic metastases to the central nervous system or meninges, or other evidence of uncontrolled metastases to the central nervous system or meninges of the subject;
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 virus infection.
Subjects with active or previous autoimmune diseases (e.g. systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), except subjects with clinically stable autoimmune thyroid disease;
Subjects with mental disorders or other conditions that pose high non-compliance risks in the opinion of the investigator;

Trial locations and contacts

1 site in 1 country.

Austria1 site

Mater Medical Centre
Brisbane, Queensland, 4101

Other trials in Austria

About this study

Official title: A Phase I, Open Label, Multi-Center, Dose Escalation Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CN1 in Patients With Advanced Solid Tumors or B-cell Lymphoma

Read the detailed description

CN1 could promote T cell activation and cytokine secretion, thereby enhancing the function of CD4+ and CD8+ T cells, and could also regulate Treg cells, thus CN1 is considered to enhance the anti-tumor immune response and have potential antitumor activity.

In this multicenter, open-label, dose-escalation Phase I study six dose levels are planned. Participants will receive CN1 by IV infusion on Day 1 of each cycle (every 3 weeks). After completion of treatment cycles, the participant will be assessed by the Principal Investigator and/or Safety Monitoring Committee (SMC).

Conditions: Advanced Solid Tumor, B Cell Lymphoma
Being tested: CN1
Medical subject headings: Lymphoma, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CN1Drug
Participants will receive CN1 by IV infusion on Day 1 of each cycle (every 3 weeks). The 5 planned dose levels are 0.03 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg and 10 mg/kg.

Study groups in NCT04418141
Study group	Role	What they receive
Single Arm	Experimental	Five planned CN1 dose levels of 0.03 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg, and 10 mg/kg. Subjects will receive CN1 by intravenous infusion (IV) on Day 1 (D1) of each cycle (once every 3 weeks per cycle). Receives: Drug: CN1

What is being measured

The primary outcome is the main question the study is designed to answer.

To determine dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and/or recommended Phase II dose (RP2D) of CN1 administered to patients with advanced solid tumor or B-cell lymphoma.
DLT is measured in the observation period of 21 days after the first dose i.e. starting dose level 0.03 mg/kg. if the enrolled subject does not experience a study drug related Grade 2 or higher adverse event (AE) per NCI-Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, the subject will start to receive the next designated dose level of 0.3 mg/kg in the second 21 days dosing cycle.
Measured: 21 Days after the first dose i.e. starting dose level 0.03 mg/kg

Secondary outcomes (10)

To assess the safety and tolerability of CN1 in patients with advanced solid tumor or B-cell lymphoma through Physical Exam
Measured by incidence of abnormal physical examination findings.
Measured: From baseline(Week 1) to 90 days after the last dose
To assess the safety and tolerability of CN1 in patients with advanced solid tumor or B-cell lymphoma through Adverse Events/Serious Adverse Events
Measured by incidence of Adverse Events/Serious Adverse Events. All AEs will be summarized according to the Medical Dictionary for Regulatory Activities (MedDRA) v23.0 or higher and the severity will be categorized by CTCAE v5.0. The summary of all AEs will be focused on the treatment-emergent adverse events (TEAEs). A TEAE is defined as any AE that starts after the first dose of study drug till 90 +/- 7 days after the last dose of study drug.
Measured: From baseline(Week 1) to 90 days after the last dose
To assess the pharmacokinetic (PK) profile of CN1 in patients with advanced solid tumor or B-cell lymphoma through Area under the plasma concentration-time curve
The following parameter is used for evaluation during PK assessments: Area under the plasma concentration-time curve (AUC0-t, AUC0- ∞, AUC0-τ)
Measured: Measurement is through treatment completion starting from Week 1 up to End of Treatment, assessed up to an average of 10 weeks.
To assess the pharmacokinetic (PK) profile of CN1 in patients with advanced solid tumor or B-cell lymphoma through Tmax
The following parameter is used for evaluation during PK assessments: Time to maximum (Tmax)
Measured: Measurement is through treatment completion starting from Week 1 up to End of Treatment, assessed up to an average of 10 weeks.
To assess the pharmacokinetic (PK) profile of CN1 in patients with advanced solid tumor or B-cell lymphoma through Apparent volume of distribution at steady state
The following parameter is used for evaluation during PK assessments: Apparent volume of distribution at steady state (Vss)
Measured: Measurement is through treatment completion starting from Week 1 up to End of Treatment, assessed up to an average of 10 weeks.
To assess the pharmacokinetic (PK) profile of CN1 in patients with advanced solid tumor or B-cell lymphoma through Accumulation factor based on AUC 0-τ
The following parameter is used for evaluation during PK assessments: Accumulation factor based on AUC 0-τ (R AUC0-τ)
Measured: Measurement is through treatment completion starting from Week 1 up to End of Treatment, assessed up to an average of 10 weeks.
To assess the immunogenicity to CN1 in patients with advanced solid tumor or B-cell lymphoma through ADA testing
A validated analysis method will be used for detection of anti-drug antibodies (ADA).
Measured: Measurement is through treatment completion starting from Week 1 up to End of Treatment, assessed up to an average of 10 weeks.
To explore the anti-tumor efficacy of CN1 in patients with advanced solid tumor or B-cell lymphoma through ORR analysis
Assessed by the number of participants with objective response (ORR)
Measured: Measurement is from Week 1, until the 90 days after the last dose, date of first documented progression or unacceptable toxicity, withdrawal of consent, subject being lost to follow-up, or death, whichever occurs first.
To explore the anti-tumor efficacy of CN1 in patients with advanced solid tumor or B-cell lymphoma through DCR analysis.
Assessed by the number of participants with Disease Control (DCR)
Measured: Measurement is from Week 1, until the 90 days after the last dose, date of first documented progression or unacceptable toxicity, withdrawal of consent, subject being lost to follow-up, or death, whichever occurs first.
To explore the anti-tumor efficacy of CN1 in patients with advanced solid tumor or B-cell lymphoma through DoR analysis.
Assessed by the number of participants with Duration of Response (DoR)
Measured: Measurement is from Week 1, until the 90 days after the last dose, date of first documented progression or unacceptable toxicity, withdrawal of consent, subject being lost to follow-up, or death, whichever occurs first.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jul 20207 Oct 2021

First posted5 Jun 2020
Study start2 Jul 2020
Primary completion7 Oct 2021
Study completion7 Oct 2021

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.
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)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04418141
Sponsor's protocol ID: CN1-101
Status last verified: Oct 2021
First submitted: 13 May 2020
Last updated: 18 Oct 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Open Label, Multi-Center, Dose Escalation Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CN1 in Patients With Advanced Solid Tumors or B-cell Lymphoma
ClinicalTrials.gov ID: NCT04418141
Acronym / sponsor ID: CN1-101
Conditions: Advanced Solid Tumor, B Cell Lymphoma
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: Curon Biopharmaceutical (Australia) Co Pty LtdIndustry (pharma, biotech, devices)
Collaborators: Novotech (Australia) Pty Limited
Study start: 2 Jul 2020 (actual)
Primary completion: 7 Oct 2021 (actual)
Study completion: 7 Oct 2021 (actual)
First posted: 5 Jun 2020 (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.

Detailed description

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: CN1Five planned CN1 dose levels of 0.03 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg, and 10 mg/kg. Subjects will receive CN1 by intravenous infusion (IV) on Day 1 (D1) of each cycle (once every 3 weeks per cycle).

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Age ≥ 18 years and ≤ 75 years old, male or female;
Subjects with histologically or cytologically diagnosed advanced malignant solid tumors or B-cell lymphoma who have failed on, or are intolerant to, standard therapy, for whom there are no standard of care regimens, or who are otherwise not eligible for standard therapy at this stage;
Subjects with Eastern Cooperative Oncology Group (ECOG) performance score of 0-1;
Females must be non-pregnant and non-lactating, and must use an acceptable, highly effective double contraception from screening until the end of the follow-up period.
Subjects must be able to understand and sign the paper informed consent before any study specific procedure.

Key exclusion criteria (12 listed)

Received anti-tumor treatment such as radiotherapy, chemotherapy, biotherapy, endocrine therapy, immunotherapy, etc., within 4 weeks prior to the first dose of study drug.
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;
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;
Use of live attenuated vaccine within 4 weeks prior to the first dose of study drug;

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
CN1Participants will receive CN1 by IV infusion on Day 1 of each cycle (every 3 weeks). The 5 planned dose levels are 0.03 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg and 10 mg/kg.	Drug	Single Arm

Primary outcome

To determine dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and/or recommended Phase II dose (RP2D) of CN1 administered to patients with advanced solid tumor or B-cell lymphoma.
Time frame: 21 Days after the first dose i.e. starting dose level 0.03 mg/kg
DLT is measured in the observation period of 21 days after the first dose i.e. starting dose level 0.03 mg/kg. if the enrolled subject does not experience a study drug related Grade 2 or higher adverse event (AE) per NCI-Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, the subject will start to receive the next designated dose level of 0.3 mg/kg in the second 21 days dosing cycle.

10 secondary outcomes

To assess the safety and tolerability of CN1 in patients with advanced solid tumor or B-cell lymphoma through Physical Exam
Time frame: From baseline(Week 1) to 90 days after the last dose
To assess the safety and tolerability of CN1 in patients with advanced solid tumor or B-cell lymphoma through Adverse Events/Serious Adverse Events
Time frame: From baseline(Week 1) to 90 days after the last dose
To assess the pharmacokinetic (PK) profile of CN1 in patients with advanced solid tumor or B-cell lymphoma through Area under the plasma concentration-time curve
Time frame: Measurement is through treatment completion starting from Week 1 up to End of Treatment, assessed up to an average of 10 weeks.
To assess the pharmacokinetic (PK) profile of CN1 in patients with advanced solid tumor or B-cell lymphoma through Tmax
Time frame: Measurement is through treatment completion starting from Week 1 up to End of Treatment, assessed up to an average of 10 weeks.
To assess the pharmacokinetic (PK) profile of CN1 in patients with advanced solid tumor or B-cell lymphoma through Apparent volume of distribution at steady state
Time frame: Measurement is through treatment completion starting from Week 1 up to End of Treatment, assessed up to an average of 10 weeks.
To assess the pharmacokinetic (PK) profile of CN1 in patients with advanced solid tumor or B-cell lymphoma through Accumulation factor based on AUC 0-τ
Time frame: Measurement is through treatment completion starting from Week 1 up to End of Treatment, assessed up to an average of 10 weeks.
To assess the immunogenicity to CN1 in patients with advanced solid tumor or B-cell lymphoma through ADA testing
Time frame: Measurement is through treatment completion starting from Week 1 up to End of Treatment, assessed up to an average of 10 weeks.
To explore the anti-tumor efficacy of CN1 in patients with advanced solid tumor or B-cell lymphoma through ORR analysis
Time frame: Measurement is from Week 1, until the 90 days after the last dose, date of first documented progression or unacceptable toxicity, withdrawal of consent, subject being lost to follow-up, or death, whichever occurs first.
To explore the anti-tumor efficacy of CN1 in patients with advanced solid tumor or B-cell lymphoma through DCR analysis.
Time frame: Measurement is from Week 1, until the 90 days after the last dose, date of first documented progression or unacceptable toxicity, withdrawal of consent, subject being lost to follow-up, or death, whichever occurs first.
To explore the anti-tumor efficacy of CN1 in patients with advanced solid tumor or B-cell lymphoma through DoR analysis.
Time frame: Measurement is from Week 1, until the 90 days after the last dose, date of first documented progression or unacceptable toxicity, withdrawal of consent, subject being lost to follow-up, or death, whichever occurs first.

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 18 Oct 2021.
Individual participant dataSharing planned: No

Related trials for Advanced Solid Tumor

Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
RecruitingPhase 1
SW-682 in Advanced Solid Tumors
Advanced Solid Tumor, Mesothelioma, Malignant
RecruitingPhase 1
Study of XB010 in Subjects With Solid Tumors
Locally Advanced or Metastatic Solid Tumors, Esophageal Squamous Cell Cancer

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.

John Park principal investigator

Macquarie University Hospital

Jim Coward principal investigator

Icon Cancer Centre (Brisbane)

Daniel Brungs principal investigator

Illawarra Cancer Care Centre (Wollongong)

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 CN1 in people with Advanced Solid Tumor and B Cell Lymphoma, run by Curon Biopharmaceutical (Australia) Co Pty Ltd at 1 site in Austria.

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 12 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 18 Oct 2021. 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 Austria. 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?

To determine dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and/or recommended Phase II dose (RP2D) of CN1 administered to patients with advanced solid tumor or B-cell lymphoma. (time frame: 21 Days after the first dose i.e. starting dose level 0.03 mg/kg). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04418141.

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 18 Oct 2021.