NCT07283367RecruitingPhase 1/2
A Phase Ib/II Trial of HS-20110 Combination Therapies in Advanced Colorectal Cancer Patients.
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.
Source: ClinicalTrials.gov · Last updated 1 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 502 (estimated)
- First submitted
- 3 Dec 2025
- Start date
- 22 Dec 2025
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- Hansoh BioMedical R&D Company
- Diseases
- Colorectal cancer
- NCT number
- NCT07283367
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 502
- From 22 Dec 2025 to the primary completion date, 31 Dec 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants who have any Grade ≥ 2 residual toxicity according to Common Terminology Criteria for Adverse Events (CTCAE, version 5.0) from prior therapies (except alopecia and residual neurotoxicity).
- Participants with a history of severe allergy (such as anaphylactic shock), previous severe infusion reactions, or allergy to recombinant human or murine proteins.
Other illness
- Participants who are allergic to any component of HS-20110 combination therapies.
Lab values
- Participants have received or are receiving the following treatment:
- Anti-tumor drugs within 14 days prior to the first dose of study treatment; any other IMPs or macromolecular anti-tumor drugs within 28 days prior to the first dose of study treatment.
- Local radiotherapy within 2 weeks prior to the first dose of study treatment; irradiation of more than 30% of bone marrow or extensive radiotherapy within 4 weeks prior to the first dose of study treatment.
- Major surgery within 4 weeks prior to the first dose of study treatment.
- Participants previously treated with drugs that are moderate to strong inhibitors or moderate to strong inducers of cytochrome P450 (CYP) 3A4, strong inhibitors or strong inducers of CYP2D6, P-glycoprotein (P-gp), breast cancer resistance protein (BCRP) or drugs with a narrow therapeutic range that are sensitive substrates of P-gp or BCRP within 7 days prior to the first dose of the IMP. Participants who need to receive these drugs during the study period should also be excluded.
- Current use of drugs known to prolong the QT interval or that may cause torsade de pointes. Participants who need to receive these drugs during the study period should also be excluded.
- Live vaccine or live-attenuated vaccine within 28 weeks prior to the first dose.
Other
- Inadequate bone marrow reserve or hepatic and renal functions.
Who the study is looking for
- Males or females, aged ≥ 18 years.
- Participants with pathologically confirmed advanced Colorectal Cancer.
- Participants have at least 1 target lesion other than CNS lesions according to RECIST 1.1.
- MSI was tested to be non-MSI-H, and without BRAF V600E mutation.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.