NCT07049458

Study of CHO-A04 in Advanced Solid Tumors

A Phase I/IIa, Open-Label, Dose-Escalation and Cohort-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CHO-A04 in Subjects With Advanced Solid Tumors

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Cho Pharma Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This Phase I/IIa, open-label, dose-escalation and cohort-expansion study aims to evaluate the safety, pharmacokinetics, and preliminary efficacy of CHO-A04 in subjects aged ≥ 18 years with advanced solid tumors. Both Phases I and Phase IIa include a screening period of up to 4 weeks and study treatment once every week starting from Cycle 1 Day 1 (C1D1) until any treatment discontinuation criterion is met. Each treatment cycle of the study treatment is 28 days. Subjects will receive intravenous (IV) infusion of CHO-A04 once a week for 4 weeks (D1, D8, D15, D22) as a treatment cycle. After the completion of last dose of the study treatment, subjects should complete the end-of-treatment (EOT) visit, safety follow-up (EOS) visit, and survival follow-up visits, unless withdrawn from this study. \- Phase I (accelerated titration and traditional 3+3 dose-escalation): Phase I consists of the accelerated titration and the traditional 3+3 dose-escalation design. Eligible subjects will be sequentially assigned into one of the dose levels. Dose level will be escalated from dose level 1 (starting dose) at 1 mg/kg/week to dose level 5 at 12 mg/kg/week of CHO-A04 (or may be de-escalated to dose level -1 at 0.5 mg/kg/week). If any ≥ Grade 2 CHO-A04 related adverse events (AEs) occurs in dose level 1 or dose level 2 subjects, the dose escalation/de-escalation rule will follow the 3+3 design. Intra-subject dose-escalation is not allowed in this study. \- Phase IIa (cohort-expansion): Two cohorts of up to 10 subjects per cohort will receive the Recommend Phase 2 Dose (R2PD), which is a dose equal to or lower than MTD based on the SRC's decision. The Sponsor will determine the cancer type for each cohort before initiation of Phase IIa.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	CHO-A04	CHO-A04 will be given intravenously (IV) once weekly for 4 weeks as a treatment cycle.

Timeline

• Start date: 2025-12-01
• Primary completion: 2027-10-01
• Completion: 2028-10-01
• First posted: 2025-07-03
• Last updated: 2025-07-03

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated drug study