Study of CHO-A04 in Advanced Solid Tumors
ConditionAdvanced Solid Tumors
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCho Pharma Inc.
About this trial
The goal of this clinical trial is to learn if the study drug, CHO-A04, works to treat solid cancers in adults. It will also aim to learn about the safety of CHO-A04 and find the best dose to use in future cancer treatment. The main questions it aims to answer are:
* Which dose of CHO-A04 shows the best anti-cancer ability? * How will your body respond to CHO-A04 treatment? * How long will CHO-A04 remain in your body?
There are two stages of investigation in this study:
* Phase I: to find the best anti-cancer dose of CHO-A04 * Phase IIa: to find the CHO-A04 anti-cancer ability in specific cancer types
In this study, each participant will be assigned to one of the CHO-A04 dose levels. Participants will have CHO-A04 infusion via blood vessel once every week for four weeks. The CHO-A04 treatment may continue based on participants' condition and CHO-A04 safety evaluations.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
With either gender aged ≥ 18 years
Histologically/cytologically confirmed, locally advanced unresectable or metastatic solid tumors
Must have been treated with established standard-of-care therapy, or physicians have determined that such established therapy is not sufficiently efficacious, or patients have declined to receive standard-of-care therapy
Tumor tissue sample collected at the time of initial diagnosis
Disqualifiers
Has unresolved toxicities from prior anticancer therapy, defined as having not resolved to ≤ Grade 1 (NCI-CTCAE v5.0), except for alopecia and laboratory values listed in the inclusion criteria
Has signs or symptoms of end-stage organ failure, major chronic illnesses other than cancer(s), or any severe concomitant conditions which, in the Investigator's opinion, make it undesirable for the subject to participate in the study, or could jeopardize compliance with the protocol
History of another primary malignancy within the last 3 years (except for treated basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, or in situ cancer of the cervix) prior to the planned first infusion
Poorly controlled hypertension (systolic blood pressure ≥ 160 mm Hg and diastolic blood pressure ≥ 100 mm Hg)
Trial design
Design model
Sequential
Treatments tested in this trial
CHO-A04
DrugCHO-A04 will be given intravenously (IV) once weekly for 4 weeks as a treatment cycle.
Treatment groups
62 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: Phase I Dose Level -1: 0.5 mg/kg/weekExperimental treatment 1 intervention
Group B: Phase I Dose Level 1: 1 mg/kg/week [starting dose]Experimental treatment 1 intervention
Group C: Phase I Dose Level 2: 2 mg/kg/weekExperimental treatment 1 intervention
Group D: Phase I Dose Level 3: 4 mg/kg/weekExperimental treatment 1 intervention
Group E: Phase I Dose Level 4: 8 mg/kg/weekExperimental treatment 1 intervention
Group F: Phase I Dose Level 5: 12 mg/kg/weekExperimental treatment 1 intervention
Group G: Phase IIa: RP2D for Cancer type AExperimental treatment 1 intervention
Group H: Phase IIa: RP2D for Cancer type BExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of subjects with dose-limiting toxicity (DLT)
DLT is evaluated based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.The 5 general grades includes Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Life-threatening or disabling, and Grade 5: Death.
Time frame
Up to 28 days after first dose (Cycle 1)2
Percentage of subjects occur with adverse events (AEs)
Percentage of subjects with treatment-emergent adverse events (TEAEs), treatment-related adverse event (TRAEs), serious adverse events (SAEs), and infusion-related reactions (IRRs) will be measured. Severity grading will be assessed by the investigator based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. The 5 general grades includes Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Life-threatening or disabling, and Grade 5: Death.
Time frame
Up to 30 days after the last doseSecondary outcomes
1
Progression-free survival (PFS)
Progression-free survival (PFS) is defined as the time from the date of initial dosing until the first date of either disease progression or death due to any cause.
Time frame
From first dose to disease progression or death, whichever occurs first, assessed up to 12 months2
Overall response rate (ORR)
ORR will be calculated by combining subjects with complete response (CR) or partial response (PR) based on RECIST v1.1 criteria in best response.
Time frame
CT assessment every 2 cycles throughout the study till EOT follow-up3
Disease control rate (DCR)
DCR is defined as the percentage of subjects with at least one complete response (CR), partial response (PR) or stable disease (SD) per RECIST v1.1.
Time frame
From first dose to confirmed disease progression, assessed up to 12 months4
Duration of response (DOR)
DOR is defined as time from the date of the first documentation of partial response (PR) or complete response (CR) per RECIST v1.1 to the date of progression
Time frame
From date of first documented response (CR or PR) to date of disease progression or death, assessed up to 12 monthsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: