Actively Recruiting
A Phase Ib/II Trial of HS-20110 Combination Therapies in Advanced Colorectal Cancer Patients.
Led by Hansoh BioMedical R&D Company · Updated on 2026-05-01
502
Participants Needed
1
Research Sites
210 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, open-label Phase Ib/II clinical study evaluating the safety, tolerability, pharmacokinetics (PK), and efficacy of the HS-20110 combination therapies in Patients with Advanced Colorectal Cancer. "Rolling 6" design would be used to conduct dose escalation part of this study. This study consists of phase Ib and phase II. After RP2D was determined in phase Ib, then a phase II study will be conducted to further evaluate the efficacy, safety, tolerability, and PK of the HS-20110 combination therapies in Patients with mCRC.
CONDITIONS
Official 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...
- Male or female aged 18 years or older
- Pathologically confirmed advanced colorectal cancer
- At least one target lesion besides central nervous system lesions, as per RECIST 1.1
- Microsatellite stable (non-MSI-H) status and no BRAF V600E mutation
You will not qualify if you...
- Received anti-tumor drugs within 14 days before starting study treatment
- Received other investigational or macromolecular anti-tumor drugs within 28 days before starting treatment
- Had local radiotherapy within 2 weeks before treatment or extensive radiotherapy involving over 30% of bone marrow within 4 weeks
- Underwent major surgery within 4 weeks before starting treatment
- Previously treated with certain drugs affecting cytochrome P450 enzymes, P-glycoprotein, or breast cancer resistance protein within 7 days before treatment or planned to receive them during the study
- Currently using drugs that prolong the QT interval or cause torsade de pointes, or planned to use them during the study
- Received live or live-attenuated vaccines within 28 weeks before treatment
- Have grade 2 or higher residual toxicity from prior therapies, except alopecia and residual neurotoxicity
- Have inadequate bone marrow, liver, or kidney function
- History of severe allergies, including anaphylactic shock or severe infusion reactions
- Allergy to any components of HS-20110 combination therapies
AI-Screening
AI-Powered Screening
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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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