CRCPhase 1/2NCT07283367
A Phase Ib/II Trial of HS-20110 Combination Therapies in Advanced Colorectal Cancer Patients.
A Phase 1/2 study testing Cohort 1: HS-20110+ Bevacizumab+5-FU/leucovorin, Cohort 2: HS-20110+Bevacizumab+Oxaliplatin+5-FU/leucovorin and Cohort 3: HS-20110+Bevacizumab+Oxaliplatin+Capecitabine in people with CRC, run by Hansoh BioMedical R&D Company at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CRC
- What is being tested?
- Cohort 1: HS-20110+ Bevacizumab+5-FU/leucovorin, Cohort 2: HS-20110+Bevacizumab+Oxaliplatin+5-FU/leucovorin and Cohort 3: HS-20110+Bevacizumab+Oxaliplatin+Capecitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 502 participants
- Where
- 1 siteChina
- Study dates
- 22 Dec 2025to 31 Dec 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou
Xuzhi Pan, 020-87343009, llwyh@sysucc.org.cn
About this study
Official title: 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.
- Conditions
- CRC
- Being tested
- Cohort 1: HS-20110+ Bevacizumab+5-FU/leucovorin, Cohort 2: HS-20110+Bevacizumab+Oxaliplatin+5-FU/leucovorin, Cohort 3: HS-20110+Bevacizumab+Oxaliplatin+Capecitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cohort 1: HS-20110+ Bevacizumab+5-FU/leucovorinDrug
HS-20110 for IV infusion of various dosage in combination with Bevacizumab+5-FU/leucovorin administered in Q2W doseing cycles
Cohort 2: HS-20110+Bevacizumab+Oxaliplatin+5-FU/leucovorinDrug
HS-20110 for IV infusion of various dosage in combination with Bevacizumab+Oxaliplatin+5-FU/leucovorin administered in Q2W doseing cycles
Cohort 3: HS-20110+Bevacizumab+Oxaliplatin+CapecitabineDrug
HS-20110 for IV infusion of various dosage in combination with Bevacizumab+Oxaliplatin+Capecitabine administered in Q3W doseing cycles
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Patients in this cohort will receive HS-20110+ Bevacizumab+5-FU/leucovorin in Q2W cycles Receives: Drug: Cohort 1: HS-20110+ Bevacizumab+5-FU/leucovorin |
| Cohort 2 | Experimental | Patients in this cohort will receive HS-20110+Bevacizumab+Oxaliplatin+5-FU/leucovorin in Q2W cycles Receives: Drug: Cohort 2: HS-20110+Bevacizumab+Oxaliplatin+5-FU/leucovorin |
| Cohort 3 | Experimental | Patients in this cohort will receive HS-20110+Bevacizumab+Oxaliplatin+Capecitabine in Q3W cycles. Receives: Drug: Cohort 3: HS-20110+Bevacizumab+Oxaliplatin+Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) or maximum applicable dose (MAD)
Measured: From day 1 to one month after the last dose in Phase 1b
Recommended phase 2 dose (RP2D)
Measured: From day 1 to one month after the last dose in Phase 1b
Objective response rate (ORR) as per RECIST v1.1
Measured: From day 1 to 3 months after the last patient enrolled in Phase 2
Secondary outcomes (8)
Incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to dose modification or permanent discontinuation, and specific laboratory abnormalities
Measured: From the first dose until 90 days after the last dose
Objective response rate (ORR)
Measured: From first dose until 3 years after last dose
Incidence of anti-HS-20110 antibody (ADA)
Measured: 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)
Measured: From the first dose until 90 days after the last dose
disease control rate (DCR)
Measured: From first dose until 3 years after last dose
duration of response (DoR)
Measured: From first dose until 3 years after last dose
progression-free survival (PFS)
Measured: From first dose until 3 years after last dose
overall survival (OS)
Measured: From first dose until 3 years after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start22 Dec 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CRCStudies of the same condition, open and under way.
- More trials run by Hansoh BioMedical R&D CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 502 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hansoh BioMedical R&D Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07283367
- Sponsor's protocol ID
- HS-20110-102
- Status last verified
- Apr 2026
- First submitted
- 3 Dec 2025
- Last updated
- 1 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07283367
- Acronym / sponsor ID
- HS-20110-102
- Conditions
- CRC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 502 participants (estimated)
- Lead sponsor
- Hansoh BioMedical R&D CompanyIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Cohort 1: HS-20110+ Bevacizumab+5-FU/leucovorinPatients in this cohort will receive HS-20110+ Bevacizumab+5-FU/leucovorin in Q2W cycles |
| Cohort 2 | Experimental | Drug: Cohort 2: HS-20110+Bevacizumab+Oxaliplatin+5-FU/leucovorinPatients in this cohort will receive HS-20110+Bevacizumab+Oxaliplatin+5-FU/leucovorin in Q2W cycles |
| Cohort 3 | Experimental | Drug: Cohort 3: HS-20110+Bevacizumab+Oxaliplatin+CapecitabinePatients in this cohort will receive HS-20110+Bevacizumab+Oxaliplatin+Capecitabine in Q3W cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- Participants have received or are receiving the following 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).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cohort 1: HS-20110+ Bevacizumab+5-FU/leucovorinHS-20110 for IV infusion of various dosage in combination with Bevacizumab+5-FU/leucovorin administered in Q2W doseing cycles | Drug | Cohort 1 |
| Cohort 2: HS-20110+Bevacizumab+Oxaliplatin+5-FU/leucovorinHS-20110 for IV infusion of various dosage in combination with Bevacizumab+Oxaliplatin+5-FU/leucovorin administered in Q2W doseing cycles | Drug | Cohort 2 |
| Cohort 3: HS-20110+Bevacizumab+Oxaliplatin+CapecitabineHS-20110 for IV infusion of various dosage in combination with Bevacizumab+Oxaliplatin+Capecitabine administered in Q3W doseing cycles | Drug | Cohort 3 |
Primary outcome
Maximum tolerated dose (MTD) or maximum applicable dose (MAD)
Time frame: 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
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
8 secondary outcomes
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
Objective response rate (ORR)
Time frame: From first dose until 3 years after last dose
Incidence of anti-HS-20110 antibody (ADA)
Time frame: 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
disease control rate (DCR)
Time frame: From first dose until 3 years after last dose
duration of response (DoR)
Time frame: From first dose until 3 years after last dose
progression-free survival (PFS)
Time frame: From first dose until 3 years after last dose
overall survival (OS)
Time frame: From first dose until 3 years after last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cohort 1: HS-20110+ Bevacizumab+5-FU/leucovorin, Cohort 2: HS-20110+Bevacizumab+Oxaliplatin+5-FU/leucovorin and Cohort 3: HS-20110+Bevacizumab+Oxaliplatin+Capecitabine in people with CRC, run by Hansoh BioMedical R&D Company at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) or maximum applicable dose (MAD) (time frame: From day 1 to one month after the last dose in Phase 1b). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.