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
Qualifiers
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
Treatments tested in this trial
- CHO-A04
Treatment groups
62 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov