Colorectal Cancer MetastaticPhase 1/2NCT07621159
A Phase Ib/II Study of HDM2017 in Combination With Standard of Care in Advanced Colorectal Cancer
A Phase 1/2 study testing HDM2017 and Fruquintinib in people with Colorectal Cancer Metastatic, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a phase Ib/II clinical study. All participants are patients with advanced colorectal cancer (CRC). The purpose of this study is to to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary anti-tumor efficacy of HDM2017 in combination with standard of care in patients with advanced… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic
- What is being tested?
- HDM2017 and Fruquintinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2026to 1 Nov 2028
- 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
- Be able and willing to provide written informed consent.
- Male or female participants with age ≥ 18 years.
- Participants with histologically or cytologically confirmed unresectable locally advanced or metastatic colorectal adenocarcinoma.
- Be able to provide archived tumor tissue during the screening period.
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
- Life expectancy ≥3 months.
Show all 10Show fewer
- According to RECIST v1.1, participants must have at least one measurable lesion.
- Has adequate organ function.
- All subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 7 months after the last dose of study treatment.
- Be willing and able to complete regular visits, treatment plans, laboratory tests, and other trial procedures.
Who cannot join
- Participants who have previously received treatment with an anti-VEGFR tyrosine kinase inhibitor (TKI).
- Participants who have previously received ADC therapy containing Top I inhibitors, or other drug therapy targeting the CDH17 target.
- Participants with other malignant tumors within the past 5 years, other than the tumor being treated in this study, with the exception of locally cured tumors (such as basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the cervix or breast).
- Related AEs from prior therapy (except for alopecia and ≤Grade 2 sensory neuropathy) have not recovered to ≤Grade 1 or baseline level.
- Known weight loss of >10% within 2 months before the first dose of study drug or other indicators showing severe malnutrition.
- History of severe esophagogastric varicose vein, severe ulcer, gastrointestinal perforation, abdominal fistula, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months before the first dose.
Show all 11Show fewer
- Participants with current imaging or clinical evidence of significant gastrointestinal obstruction.
- Participants with clinically significant bleeding symptoms within 1 month before the first IMP dose.
- Participants with known active CNS metastasis.
- Participants with cardiovascular/cerebrovascular disorder, symptoms, or manifestations.
- Participants with active syphilis, history of human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) or active hepatitis C virus (HCV), except for asymptomatic chronic hepatitis B or C virus carriers.
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
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142
Lin Shen, 010-88196561, doctorshenlin@sina.cn
About this study
Official title: A Phase Ib/II Clinical Study to Evaluate the Preliminary Efficacy and Safety of HDM2017 in Combination With Standard of Care in Participants With Advanced Colorectal Cancer
This is a phase Ib/II clinical study. All participants are patients with advanced colorectal cancer (CRC). The purpose of this study is to to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary anti-tumor efficacy of HDM2017 in combination with standard of care in patients with advanced CRC.
- Conditions
- Colorectal Cancer Metastatic
- Being tested
- HDM2017, Fruquintinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDM2017Drug
Following a predefined dose and date.
FruquintinibDrug
Following a predefined dose and date.
| Study group | Role | What they receive |
|---|---|---|
| HDM2017 in combination with fruquintinib | Experimental | Not described Receives: Drug: HDM2017; Drug: Fruquintinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
The MTD will be determined using DLTs
Measured: 30 days after the last dose of IMP]
Recommended Phase 2 Dose (RP2D)
The RP2D will be determined using dose limiting toxicities (DLTs) and all other available study data
Measured: 30 days after the last dose of IMP
Type, incidence and severity of Adverse Events
Safety and tolerability profile assessed by the Common Terminology Criteria for Adverse Events v6.0
Measured: 30 days after the last dose of IMP
Objective Response Rate (ORR)
ORR is defined as the proportion of subjects with BOR response of CR or PR (based on RECIST Version 1.1).
Measured: 30 days after the last dose of IMP
Secondary outcomes (7)
Tmax
Time to reach the maximum blood concentration
Measured: 30 days after the last dose of IMP]
Cmax
Maximum observed blood concentration
Measured: 30 days after the last dose of IMP
Incidence of anti-drug antibody (ADA)
The proportion of patients with positive ADA results
Measured: 30 days after the last dose of IMP
Disease control rate (DCR)
DCR is defined as the proportion of subjects with response of CR, PR and SD (based on RECIST Version 1.1)
Measured: 30 days after the last dose of IMP
Duration of Response (DoR)
The time from first documented evidence of CR or PR until time of first documented disease progression.
Measured: 30 days after the last dose of IMP
Progression Free Survival (PFS)
PFS is defined as the interval between first dose and the earliest date of disease progression or death due to any cause
Measured: 30 days after the last dose of IMP
Overall survival (OS)
OS is defined as the time from first dose until death due to any cause
Measured: 30 days after the last dose of IMP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start15 Jul 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.The 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07621159
- Sponsor's protocol ID
- HDM2017-201
- Status last verified
- May 2026
- First submitted
- 27 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Clinical Study to Evaluate the Preliminary Efficacy and Safety of HDM2017 in Combination With Standard of Care in Participants With Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07621159
- Acronym / sponsor ID
- HDM2017-201
- Conditions
- Colorectal Cancer Metastatic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 2 Jun 2026 (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 phase Ib/II clinical study. All participants are patients with advanced colorectal cancer (CRC). The purpose of this study is to to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary anti-tumor efficacy of HDM2017 in combination with standard of care in patients with advanced CRC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HDM2017 in combination with fruquintinib | Experimental | Drug: HDM2017, Drug: Fruquintinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Be able and willing to provide written informed consent.
- Male or female participants with age ≥ 18 years.
- Participants with histologically or cytologically confirmed unresectable locally advanced or metastatic colorectal adenocarcinoma.
- Be able to provide archived tumor tissue during the screening period.
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
Key exclusion criteria (11 listed)
- Participants who have previously received treatment with an anti-VEGFR tyrosine kinase inhibitor (TKI).
- Participants who have previously received ADC therapy containing Top I inhibitors, or other drug therapy targeting the CDH17 target.
- Participants with other malignant tumors within the past 5 years, other than the tumor being treated in this study, with the exception of locally cured tumors (such as basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the cervix or breast).
- Related AEs from prior therapy (except for alopecia and ≤Grade 2 sensory neuropathy) have not recovered to ≤Grade 1 or baseline level.
- Known weight loss of >10% within 2 months before the first dose of study drug or other indicators showing severe malnutrition.
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 |
|---|---|---|
| HDM2017Following a predefined dose and date. | Drug | HDM2017 in combination with fruquintinib |
| FruquintinibFollowing a predefined dose and date. | Drug | HDM2017 in combination with fruquintinib |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: 30 days after the last dose of IMP]
The MTD will be determined using DLTs
Recommended Phase 2 Dose (RP2D)
Time frame: 30 days after the last dose of IMP
The RP2D will be determined using dose limiting toxicities (DLTs) and all other available study data
Type, incidence and severity of Adverse Events
Time frame: 30 days after the last dose of IMP
Safety and tolerability profile assessed by the Common Terminology Criteria for Adverse Events v6.0
Objective Response Rate (ORR)
Time frame: 30 days after the last dose of IMP
ORR is defined as the proportion of subjects with BOR response of CR or PR (based on RECIST Version 1.1).
7 secondary outcomes
Tmax
Time frame: 30 days after the last dose of IMP]
Cmax
Time frame: 30 days after the last dose of IMP
Incidence of anti-drug antibody (ADA)
Time frame: 30 days after the last dose of IMP
Disease control rate (DCR)
Time frame: 30 days after the last dose of IMP
Duration of Response (DoR)
Time frame: 30 days after the last dose of IMP
Progression Free Survival (PFS)
Time frame: 30 days after the last dose of IMP
Overall survival (OS)
Time frame: 30 days after the last dose of IMP
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 2 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Colorectal Cancer Metastatic
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
Metastatic Colorectal Cancer
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
Not yet recruitingPhase 1/2
A Phase Ib/II Study of GFH276 in Combination With Chemotherapy (± Bevacizumab) or Cetuximab in Patients With RAS-mutant Metastatic Colorectal Cancer
CRC
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 HDM2017 and Fruquintinib in people with Colorectal Cancer Metastatic, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. 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 10 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: opening soon, as of the sponsor's last update on 2 Jun 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?
Contact Ruichao Zeng (0571-89918267, zengruichao@eastchinapharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) (time frame: 30 days after the last dose of IMP]). The study lists 4 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 2 Jun 2026.