Study of CM518D1 in Patients With Advanced Solid Tumors
ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorKeymed Biosciences Co.Ltd
About this trial
This is an interventional study to assess the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of CM518D1 in patients with advanced solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Male or female ≥ 18 and ≤75 years of age.
2. Subjects with histologically or cytologically confirmed advanced solid tumors.
3. At least one measurable lesion according to RECIST v1.1.
4. Expected survival time ≥ 3 months as judged by the Investigator.
Disqualifiers
1. Subjects who have received any chemotherapy or any drug therapy for antitumor treatment including monoclonal antibodies, targeted therapy, radioimmunoconjugates, or Antibody-Drug Conjugates(ADCs), or any investigational product therapy for anti-tumor therapy within 28 days prior to the first dose or within 5 half-lives (whichever is shorter).
2. Subjects who have received major surgery within 28 days prior to the first dose.
3. Subjects who have received radiotherapy within 21 days prior to the first dose.
4. Subjects who have received systemic glucocorticoid therapy (more than 10 mg of prednisone or equivalent daily) or other forms of immunosuppressive therapy within 7 days prior to the first dose.
Trial design
Design model
Parallel
Treatments tested in this trial
CM518D1
Biological/VaccineCM518D1 will be administered intravenously once every 3 weeks (Q3W) in 6 predetermined dose levels.
CM518D1
Biological/VaccineCM518D1 will be administered intravenously once every 3 weeks (Q3W) in one or more potential recommended phase 2 dose(RP2D).
CM518D1
Biological/VaccineCM518D1 will be administered intravenously once every 3 weeks (Q3W) in different types of solid tumor cohorts.
Treatment groups
434 Participants
are divided into 3 treatment groupsGroup A: Phase I dose escalationExperimental treatment 1 intervention
Group B: Phase I dose expansionExperimental treatment 1 intervention
Group C: Phase IIExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose Limiting Toxicity (DLT)-Phase I dose escalation
DLT is defined as a toxicity occurring during the DLT observation period.
Time frame
First cycle (21 days)2
Incidence of adverse events (AEs), serious adverse events (SAEs), and specific laboratory abnormalities-Phase I dose escalation
An adverse event is defined as any unfavorable medical event that occurs in a subject after receiving the investigational drug, which will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria.
Time frame
Through study completion, an average of 2 years.3
Incidence of adverse events (AEs), serious adverse events (SAEs), and specific laboratory abnormalities-Phase I dose expansion
An adverse event is defined as any unfavorable medical event that occurs in a subject after receiving the investigational drug, which will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria.
Time frame
Through study completion, an average of 2 years.]4
Preliminary efficacy-Phase I dose expansion
Preliminary efficacy includes objective response rate (ORR), duration of response (DOR), disease control rate (DCR), time to response (TTR), and progression-free survival (PFS).
Time frame
Through study completion, an average of 2 years.]Sponsors and contacts
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Source ClinicalTrials.gov