CRC, Colorectal CancerPhase 1/2NCT07805551
A Study of HDM2017 Combination Therapy in Advanced Colorectal Cancer
A Phase 1/2 study testing HDM2017, Bevacizumab and Oxaliplatin in people with CRC, Colorectal Cancer, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a multicenter, open-label, dose-escalation/dose-expansion, Phase Ib/II study to evaluate the safety, tolerability, PK characteristics, and preliminary anti-tumor efficacy of HDM2017 combination therapy in participants with advanced CRC. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- CRC, Colorectal Cancer
- What is being tested?
- HDM2017, Bevacizumab and Oxaliplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 18 Aug 2026to Aug 2032
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must voluntarily participate in this study and sign the written ICF after being fully informed.
- Male or female participants aged 18 to 75 years (inclusive).
- Participants with histologically or cytologically confirmed unresectable locally advanced or metastatic CRC.
- Able to provide fresh or archived tumor tissue samples during the screening period.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
- Life expectancy ≥ 3 months.
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- Participants must have at least one measurable lesion according to RECIST v1.1.
- Laboratory test results at the screening period must indicate that the participant has adequate organ function.
- Women of childbearing potential (WOCBP) must agree to use a reasonable method of contraception from the time of signing the ICF until 7 months after the last dose; and must have a negative serum human chorionic gonadotropin (HCG) test within 7 days before the first dose. Male participants must agree to use adequate contraception from the first dose until 7 months after the last dose.
- Participants must be willing and able to complete regular visits, treatment plans, laboratory tests, and other study procedures.
Who cannot join
- Prior or current treatment with topoisomerase I (TOP I) inhibitor drugs.
- Prior or current treatment targeting CDH17.
- Presence of other malignant tumor, other than the tumor being treated in this study.
- AEs from prior therapy that have not resolved to Grade 1 or baseline status before prior therapy.
- Active central nervous system (CNS) metastasis; metastases to meninges or brainstem metastasis; presence of spinal cord compression.
- Presence of diseases that may affect the efficacy and safety of the IMP.
- Known or suspected allergic reaction or contraindication to any component of the IMP or its analogues.
- Pregnant or lactating women, or those who plan to become pregnant during the study.
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
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142
Ruichao Zeng, 0571-89918267, zengruichao@eastchinapharm.com
About this study
Official title: A Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HDM2017 Combination Therapy in Participants With Advanced Colorectal Cancer
This is a multicenter, open-label, dose-escalation/dose-expansion, Phase Ib/II study to evaluate the safety, tolerability, PK characteristics, and preliminary anti-tumor efficacy of HDM2017 combination therapy in participants with advanced CRC. The study is divided into two periods: dose escalation (Phase Ib) and dose expansion (Phase II). Phase Ib of this study is a dose-finding study of different HDM2017 combination therapies. The Phase II study will be conducted at a dose determined to be safe and potentially effective in Phase Ib.
- Conditions
- CRC, Colorectal Cancer
- Being tested
- HDM2017, Bevacizumab, Oxaliplatin, Fluorouracil, Capecitabine
- Keywords
- HDM2017, CRC
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDM2017Drug
Administered with continuing until protocol-specified criteria for treatment discontinuation are met
BevacizumabDrug
administered with continuing until protocol-specified criteria for treatment discontinuation are met
OxaliplatinDrug
administered with continuing until protocol-specified criteria for treatment discontinuation are met
FluorouracilDrug
administered with continuing until protocol-specified criteria for treatment discontinuation are met
CapecitabineDrug
administered with continuing until protocol-specified criteria for treatment discontinuation are met
LeucovorinDrug
administered with dosing continuing until protocol-specified criteria for treatment discontinuation are met
| Study group | Role | What they receive |
|---|---|---|
| HDM2017 + bevacizumab + oxaliplatin + leucovorin + fluorouracil | Experimental | Not described Receives: Drug: HDM2017; Drug: Bevacizumab; Drug: Oxaliplatin; Drug: Fluorouracil; Drug: Leucovorin |
| HDM2017 + bevacizumab + leucovorin + fluorouracil | Experimental | Not described Receives: Drug: HDM2017; Drug: Bevacizumab; Drug: Fluorouracil; Drug: Leucovorin |
| HDM2017 + bevacizumab + oxaliplatin + capecitabine | Experimental | Not described Receives: Drug: HDM2017; Drug: Bevacizumab; Drug: Oxaliplatin; Drug: Capecitabine |
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: From date of first-dosing until the date of first documented progression or date of 30 days after the last dose of IMP, whichever came first, assessed up to about 12 months
Secondary outcomes (5)
Disease control rate (DCR)
Measured: 30 days after the last dose of IMP
Duration of Response (DoR)
Measured: From date of confirm ORR until the date of first documented progression, assessed up to about 36 months
Progression Free Survival (PFS)
Measured: From date of first-dosing/randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to about 36 months
Overall survival (OS)
Measured: From date of first-dosing/randomization until the end of the trail or date of death from any cause, whichever came first, assessed up to about 48 months
Incidence of anti-drug antibody (ADA)
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 posted4 Sep 2026
- Study start18 Aug 2026
- Primary completionAug 2030 (estimated)
- Study completionAug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CRC, Colorectal CancerStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07805551
- Sponsor's protocol ID
- HDM2017-202
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Sep 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 Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HDM2017 Combination Therapy in Participants With Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07805551
- Acronym / sponsor ID
- HDM2017-202
- Conditions
- CRC, Colorectal Cancer
- Keywords
- HDM2017, CRC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Aug 2026 (actual)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Aug 2032 (estimated)
- First posted
- 4 Sep 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 multicenter, open-label, dose-escalation/dose-expansion, Phase Ib/II study to evaluate the safety, tolerability, PK characteristics, and preliminary anti-tumor efficacy of HDM2017 combination therapy in participants with advanced CRC. The study is divided into two periods: dose escalation (Phase Ib) and dose expansion (Phase II). Phase Ib of this study is a dose-finding study of different HDM2017 combination therapies. The Phase II study will be conducted at a dose determined to be safe and potentially effective in Phase Ib.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HDM2017 + bevacizumab + oxaliplatin + leucovorin + fluorouracil | Experimental | Drug: HDM2017, Drug: Bevacizumab, Drug: Oxaliplatin, Drug: Fluorouracil, Drug: Leucovorin |
| HDM2017 + bevacizumab + leucovorin + fluorouracil | Experimental | Drug: HDM2017, Drug: Bevacizumab, Drug: Fluorouracil, Drug: Leucovorin |
| HDM2017 + bevacizumab + oxaliplatin + capecitabine | Experimental | Drug: HDM2017, Drug: Bevacizumab, Drug: Oxaliplatin, Drug: Capecitabine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participants must voluntarily participate in this study and sign the written ICF after being fully informed.
- Male or female participants aged 18 to 75 years (inclusive).
- Participants with histologically or cytologically confirmed unresectable locally advanced or metastatic CRC.
- Able to provide fresh or archived tumor tissue samples during the screening period.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
Key exclusion criteria (8 listed)
- Prior or current treatment with topoisomerase I (TOP I) inhibitor drugs.
- Prior or current treatment targeting CDH17.
- Presence of other malignant tumor, other than the tumor being treated in this study.
- AEs from prior therapy that have not resolved to Grade 1 or baseline status before prior therapy.
- Active central nervous system (CNS) metastasis; metastases to meninges or brainstem metastasis; presence of spinal cord compression.
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 |
|---|---|---|
| HDM2017Administered with continuing until protocol-specified criteria for treatment discontinuation are met | Drug | HDM2017 + bevacizumab + leucovorin + fluorouracil, HDM2017 + bevacizumab + oxaliplatin + capecitabine, HDM2017 + bevacizumab + oxaliplatin + leucovorin + fluorouracil |
| Bevacizumabadministered with continuing until protocol-specified criteria for treatment discontinuation are met | Drug | HDM2017 + bevacizumab + leucovorin + fluorouracil, HDM2017 + bevacizumab + oxaliplatin + capecitabine, HDM2017 + bevacizumab + oxaliplatin + leucovorin + fluorouracil |
| Oxaliplatinadministered with continuing until protocol-specified criteria for treatment discontinuation are met | Drug | HDM2017 + bevacizumab + oxaliplatin + capecitabine, HDM2017 + bevacizumab + oxaliplatin + leucovorin + fluorouracil |
| Fluorouraciladministered with continuing until protocol-specified criteria for treatment discontinuation are met | Drug | HDM2017 + bevacizumab + leucovorin + fluorouracil, HDM2017 + bevacizumab + oxaliplatin + leucovorin + fluorouracil |
| Capecitabineadministered with continuing until protocol-specified criteria for treatment discontinuation are met | Drug | HDM2017 + bevacizumab + oxaliplatin + capecitabine |
| Leucovorinadministered with dosing continuing until protocol-specified criteria for treatment discontinuation are met | Drug | HDM2017 + bevacizumab + leucovorin + fluorouracil, HDM2017 + bevacizumab + oxaliplatin + leucovorin + fluorouracil |
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: From date of first-dosing until the date of first documented progression or date of 30 days after the last dose of IMP, whichever came first, assessed up to about 12 months
ORR is defined as the proportion of subjects with BOR response of CR or PR (based on RECIST Version 1.1).
5 secondary outcomes
Disease control rate (DCR)
Time frame: 30 days after the last dose of IMP
Duration of Response (DoR)
Time frame: From date of confirm ORR until the date of first documented progression, assessed up to about 36 months
Progression Free Survival (PFS)
Time frame: From date of first-dosing/randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to about 36 months
Overall survival (OS)
Time frame: From date of first-dosing/randomization until the end of the trail or date of death from any cause, whichever came first, assessed up to about 48 months
Incidence of anti-drug antibody (ADA)
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 4 Sep 2026.
- Individual participant dataSharing planned: No
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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 HDM2017, Bevacizumab and Oxaliplatin in people with CRC, Colorectal Cancer, 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 8 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 4 Sep 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 Lin Shen (010-88196561, doctorshenlin@sina.cn), 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 4 Sep 2026.