Advanced Solid Tumors and Hematologic MalignanciesPhase 1NCT05690581
Safety, Tolerability, Pharmacokinetic Characteristics, and Efficacy of CM369 in Advanced Solid Tumors & Hematologic Malignancies
A Phase 1 study testing CM369 in people with Advanced Solid Tumors and Hematologic Malignancies, run by Beijing InnoCare Pharma Tech Co., Ltd. at 3 sites in China.
Trial summary
This is a nonrandomized, open-label, multicenter, phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of CM369 in subjects with advanced solid tumors and Hematologic Malignancies. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors and Hematologic Malignancies
- What is being tested?
- CM369
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 3 sitesChina
- Study dates
- 23 Feb 2023to 28 Feb 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
- Solid tumor Inclusion Criteria:
- Life expectancy ≥12 weeks.
- Eastern Cooperative Oncology Group performance status of 0-1.
- Subjects with cytology and/or histologically confirmed locally advanced unresectable or metastatic solid tumors.
- Agree to provide archived tumor tissue samples of primary or metastatic lesions.
- Phase Ia: have at least one measurable lesion or one evaluable lesion according to RECIST 1.1.
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- Have adequate organ function as described in the protocol.
- Hematologic Malignancies Inclusion Criteria:
- Male and female subjects ≥18 years of age and ≤ 75 years of age.
- This study enroll subjects with recurrent/refractory hematological tumors.
- The subjects must have measurable lesions.
- Positive CCR8in tumor tissues of subjects.
- Eastern Cooperative Oncology Group performance status (ECOG) of ≤2, and had a Life expectancy of at least 3 months.
- Adequate hematological function, defined as protocol.
- Subjects with normal coagulation function, defined as protocol.
- Adequate hepatic, renal and cardiac functions, defined as protocol.
- Subjects voluntarily signed informed consent form (ICF) and written informed consent must be obtained prior to performing any study-related procedure.
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to receiving the first dose of study medication.
- WOCBP or male subjects and their female partners of childbearing potential must be willing to use an appropriate method of contraception during the study and for 6 months after the last dose, and must not donate eggs or sperms during this period.
- Female subjects were not allowed to breastfeed during the study and for at least 6 months after the last dose of study medication.
Who cannot join
- Solid tumor Exclusion Criteria:
- Subjects with primary central nervous system (CNS) tumors or unstable CNS metastases.
- Subjects who have uncontrollable or major cardiovascular disease refer to protocol.
- Subjects who have an active autoimmune disease or have had an autoimmune disease with risk of recurrence.
- Subjects who have active or history of interstitial lung disease or non-infectious pneumonia.
- Subjects with any active infection requiring systemic treatment by intravenous infusion within 14 days prior to the first administration of the study drug.
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- HIV infection; Hepatitis C virus (HCV) antibody positive; HCV infection.
- History of active bleeding within 2 months before screening, or bleeding symptoms associated with application of anticoagulant drugs or other interventions.
- Have not recovered to CTCAE Grade 1 or better from the adverse events due to previous cancer therapies.
- Subjects who received systemic immunosuppressive drugs within 14 days prior to the first administration of the study drug.
- Subjects who require systemic treatment of corticosteroids or other immunosuppressive agents within 14 days prior to first dose.
- Has a history of severe allergic reactions to monoclonal antibodies.
- Subjects with any mental or cognitive impairment that may limit their understanding, implementation.
- Hematologic Malignancies Exclusion Criteria:
- Previous treatment with immune checkpoint inhibitors
- Autologous hematopoietic stem cell transplantation within 100 days prior to first investigational medications dose, or history of allogeneic hematopoietic stem cell transplantation.
- Subjects currently suffering from acute graft-versus-host disease (GVHD) or active chronic GVHD.
- Have had any therapy directed against the subject's underlying cancer within 28 days prior to first investigational medications dose.
- Received other clinical trial drugs within 28 days prior to first investigational medications dose.
- Subjects who experienced major organ surgery (except for needle biopsy) or significant trauma within 28 days prior to first investigational medications administration, or who need selected surgical procedures during the study.
- Subjects who have been vaccinated with live attenuated vaccine within 28 days prior to first investigational medications administration.
- Clinical evidence of central nervous system (CNS) metastasis will be excluded.
- Previous or concomitant with CNS diseases.
- History of another primary malignancy not in remission for at least 2 years.
- Any severe active infection requiring systemic antimicrobial therapy.
- Active hepatitis B or C virus infection.
- History of immunodeficiency, including human immunodeficiency virus (HIV) antibody positive or known syphilis infection.
- History of severe cardiovascular and cerebrovascular diseases.
- Subjects who currently or have suffered from severe interstitial lung disease.
- The toxicity of previous anti-tumor therapy is still ≥ grade 2 at enrollment.
- History of severe bleeding disorders,.
- Known alcohol or drug dependence.
- Subjects with mental disorders or poor compliance.
- Pregnant or lactating female subjects.
- Any other condition that, in the opinion of the investigator or project clinician, would interfere with a subject's ability to receive or complete the study.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Jilin Cancer Hospital
Changchun, Jilin, 130000
Ying Cheng, 0431-80596315, JL.Cheng@163.com
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Liqun Zou
Lin Wang
- Recruiting
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060
Ruihua Xu
About this study
Official title: A Nonrandomized, Open-label, Multicenter, Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Efficacy of CM369 in Subjects with Advanced Solid Tumors and Hematologic Malignancies
This is a nonrandomized, open-label, multicenter, phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of CM369 in subjects with advanced solid tumors and Hematologic Malignancies.
- Being tested
- CM369
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM369Drug
Specified dose on specified days.
| Study group | Role | What they receive |
|---|---|---|
| CM369 Ia Dose Escalation | Experimental | Dose escalation of CM369 as monotherapy Receives: Drug: CM369 |
| CM369 Ib Dose Expansion | Experimental | Dose expansion of CM369 as monotherapy Receives: Drug: CM369 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
Measured: 90 weeks
Serious Adverse events (SAEs)
Measured: 90 weeks
Dose limiting toxicities (DLTs)
Measured: 90 weeks
Secondary outcomes (6)
PK parameter: Peak Time (Tmax)
Measured: 90 weeks
PK parameter: Half-life (t1/2)
Measured: 90 weeks
PK parameter: Area Under the Curve (AUC)
Measured: 90 weeks
PK parameters: Clearance (CL)
Measured: 90 weeks
PK parameter: Apparent volume of distribution of steady state (Vss)
Measured: 90 weeks
Immunogenicity: Incidence of anti-CM369 antibody
Measured: 90 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start23 Feb 2023
- Primary completion30 Oct 2025 (estimated)
- Study completion28 Feb 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 Tumors and Hematologic MalignanciesStudies of the same condition, open and under way.
- More trials run by Beijing InnoCare Pharma Tech 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05690581
- Sponsor's protocol ID
- CM369-001
- Status last verified
- Dec 2024
- First submitted
- 10 Jan 2023
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nonrandomized, Open-label, Multicenter, Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Efficacy of CM369 in Subjects with Advanced Solid Tumors and Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT05690581
- Acronym / sponsor ID
- CM369-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 19 Jan 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 is a nonrandomized, open-label, multicenter, phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of CM369 in subjects with advanced solid tumors and Hematologic Malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CM369 Ia Dose Escalation | Experimental | Drug: CM369Dose escalation of CM369 as monotherapy |
| CM369 Ib Dose Expansion | Experimental | Drug: CM369Dose expansion of CM369 as monotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Life expectancy ≥12 weeks.
- Eastern Cooperative Oncology Group performance status of 0-1.
- Subjects with cytology and/or histologically confirmed locally advanced unresectable or metastatic solid tumors.
- Agree to provide archived tumor tissue samples of primary or metastatic lesions.
- Phase Ia: have at least one measurable lesion or one evaluable lesion according to RECIST 1.1.
Key exclusion criteria (35 listed)
- Subjects with primary central nervous system (CNS) tumors or unstable CNS metastases.
- Subjects who have uncontrollable or major cardiovascular disease refer to protocol.
- Subjects who have an active autoimmune disease or have had an autoimmune disease with risk of recurrence.
- Subjects who have active or history of interstitial lung disease or non-infectious pneumonia.
- Subjects with any active infection requiring systemic treatment by intravenous infusion within 14 days prior to the first administration of the 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 |
|---|---|---|
| CM369Specified dose on specified days. | Drug | CM369 Ia Dose Escalation, CM369 Ib Dose Expansion |
Primary outcome
Adverse events (AEs)
Time frame: 90 weeks
Serious Adverse events (SAEs)
Time frame: 90 weeks
Dose limiting toxicities (DLTs)
Time frame: 90 weeks
6 secondary outcomes
PK parameter: Peak Time (Tmax)
Time frame: 90 weeks
PK parameter: Half-life (t1/2)
Time frame: 90 weeks
PK parameter: Area Under the Curve (AUC)
Time frame: 90 weeks
PK parameters: Clearance (CL)
Time frame: 90 weeks
PK parameter: Apparent volume of distribution of steady state (Vss)
Time frame: 90 weeks
Immunogenicity: Incidence of anti-CM369 antibody
Time frame: 90 weeks
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 27 Dec 2024.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CM369 in people with Advanced Solid Tumors and Hematologic Malignancies, run by Beijing InnoCare Pharma Tech Co., Ltd. at 3 sites 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 20 inclusion and 35 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: looking for participants now, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Ruihua Xu (13922296676, xurh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AEs) (time frame: 90 weeks). 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 27 Dec 2024.