Actively Recruiting
A Phase Ib/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-20110 Combination Therapies in Patients With Advanced Colorectal Cancer
Led by Hansoh BioMedical R&D Company · Updated on 2026-05-01
502
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and effectiveness of HS-20110 combination therapies in patients with advanced colorectal cancer. This multicenter, open-label Phase Ib/II study uses a "Rolling 6" design for dose escalation in Phase Ib, followed by Phase II to further assess these treatments in patients with metastatic colorectal cancer (mCRC). The study includes three treatment groups receiving different HS-20110 combinations: one with Bevacizumab and 5-FU/leucovorin every two weeks, another with Bevacizumab, Oxaliplatin, and 5-FU/leucovorin every two weeks, and a third with Bevacizumab, Oxaliplatin, and Capecitabine every three weeks. The treatments are given via intravenous infusion in cycles, with doses adjusted during the study. Participants will be monitored for safety, side effects, drug levels, and response to treatment. Assessments include tumor response using RECIST v1.1 criteria, adverse events, antibody formation against HS-20110, and survival outcomes. Monitoring continues from the first dose until up to three years after the last dose. The study aims to determine the best dose and evaluate the impact on disease control and patient survival over time.
CONDITIONS
Brief Title
A Phase Ib/II Trial of HS-20110 Combination Therapies in Advanced Colorectal Cancer Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 18 years or older
- Pathologically confirmed advanced colorectal cancer
- At least one target lesion other than CNS lesions according to RECIST 1.1
- Tested negative for MSI-H and BRAF V600E mutation
You will not qualify if you...
- Received anti-tumor drugs within 14 days or other investigational drugs within 28 days before first study dose
- Had local radiotherapy within 2 weeks or extensive radiotherapy within 4 weeks before first study dose
- Underwent major surgery within 4 weeks prior to first study dose
- Previously treated with certain drugs affecting CYP3A4, CYP2D6, P-gp, or BCRP within 7 days before first dose or needing these drugs during study
- Currently using drugs that prolong QT interval or cause torsade de pointes or needing them during study
- Received live or live-attenuated vaccine within 28 weeks before first dose
- Any grade 2 or higher residual toxicity from prior therapies except alopecia and residual neurotoxicity
- Inadequate bone marrow, liver, or kidney function
- History of severe allergy, severe infusion reactions, or allergy to recombinant human or murine proteins
- Allergy to any component of HS-20110 combination therapies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 2-week or 3-week cycles until disease progression or discontinuation
Participants receive HS-20110 in combination with other chemotherapy drugs in dosing cycles depending on their cohort assignment.
Visits every 2 weeks for Cohorts 1 and 2; visits every 3 weeks for Cohort 3
Duration - Up to 3 years after last dose
Participants are monitored for safety, efficacy, and survival for up to 3 years after treatment ends.
Periodic visits during follow-up period
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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