A Phase Ib/II Trial of HS-20110 Combination Therapies in Advanced Colorectal Cancer Patients.

April 27, 2026 updated by: Hansoh BioMedical R&D Company

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

502

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Guangzhou, China
        • Recruiting
        • Sun yat-sen University Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Participants have received or are receiving the following treatment:

    1. 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.
    2. 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.
    3. Major surgery within 4 weeks prior to the first dose of study treatment.
    4. 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.
    5. 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.
    6. Live vaccine or live-attenuated vaccine within 28 weeks prior to the first dose.
  • 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).
  • Inadequate bone marrow reserve or hepatic and renal functions.
  • Participants with a history of severe allergy (such as anaphylactic shock), previous severe infusion reactions, or allergy to recombinant human or murine proteins.
  • Participants who are allergic to any component of HS-20110 combination therapies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
Patients in this cohort will receive HS-20110+ Bevacizumab+5-FU/leucovorin in Q2W cycles
Drug: Cohort 1: HS-20110+ Bevacizumab+5-FU/leucovorin
HS-20110 for IV infusion of various dosage in combination with Bevacizumab+5-FU/leucovorin administered in Q2W doseing cycles
Experimental: Cohort 2
Patients in this cohort will receive HS-20110+Bevacizumab+Oxaliplatin+5-FU/leucovorin in Q2W cycles
Drug: Cohort 2: HS-20110+Bevacizumab+Oxaliplatin+5-FU/leucovorin
HS-20110 for IV infusion of various dosage in combination with Bevacizumab+Oxaliplatin+5-FU/leucovorin administered in Q2W doseing cycles
Experimental: Cohort 3
Patients in this cohort will receive HS-20110+Bevacizumab+Oxaliplatin+Capecitabine in Q3W cycles.
Drug: Cohort 3: HS-20110+Bevacizumab+Oxaliplatin+Capecitabine
HS-20110 for IV infusion of various dosage in combination with Bevacizumab+Oxaliplatin+Capecitabine administered in Q3W doseing cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum tolerated dose (MTD) or maximum applicable dose (MAD)
Time Frame: From day 1 to one month after the last dose in Phase 1b
From day 1 to one month after the last dose in Phase 1b
Recommended phase 2 dose (RP2D)
Time Frame: From day 1 to one month after the last dose in Phase 1b
From day 1 to one month after the last dose in Phase 1b
Objective response rate (ORR) as per RECIST v1.1
Time Frame: From day 1 to 3 months after the last patient enrolled in Phase 2
From day 1 to 3 months after the last patient enrolled in Phase 2

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to dose modification or permanent discontinuation, and specific laboratory abnormalities
Time Frame: From the first dose until 90 days after the last dose
From the first dose until 90 days after the last dose
Incidence of anti-HS-20110 antibody (ADA)
Time Frame: From the first dose until 90 days after the last dose
From the first dose until 90 days after the last dose
Drug concentrations of the three components of HS-20110 (including antibody-drug conjugates, total antibody, and payload)
Time Frame: From the first dose until 90 days after the last dose
From the first dose until 90 days after the last dose
Objective response rate (ORR)
Time Frame: From first dose until 3 years after last dose
From first dose until 3 years after last dose
disease control rate (DCR)
Time Frame: From first dose until 3 years after last dose
From first dose until 3 years after last dose
duration of response (DoR)
Time Frame: From first dose until 3 years after last dose
From first dose until 3 years after last dose
progression-free survival (PFS)
Time Frame: From first dose until 3 years after last dose
From first dose until 3 years after last dose
overall survival (OS)
Time Frame: From first dose until 3 years after last dose
From first dose until 3 years after last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hansoh BioMedical R&D Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2025

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

December 3, 2025

First Submitted That Met QC Criteria

December 11, 2025

First Posted (Actual)

December 15, 2025

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • HS-20110-102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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