Colorectal Cancer Metastatic
Conditions
Brief 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 CRC.
Interventions
DRUGHDM2017
Following a predefined dose and date.
DRUGFruquintinib
Following a predefined dose and date.
Sponsors
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Be able and willing to provide written informed consent. 2. Male or female participants with age ≥ 18 years. 3. Participants with histologically or cytologically confirmed unresectable locally advanced or metastatic colorectal adenocarcinoma. 4. Be able to provide archived tumor tissue during the screening period. 5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1. 6. Life expectancy ≥3 months. 7. According to RECIST v1.1, participants must have at least one measurable lesion. 8. Has adequate organ function. 9. 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. 10. Be willing and able to complete regular visits, treatment plans, laboratory tests, and other trial procedures.
Exclusion criteria
1. Participants who have previously received treatment with an anti-VEGFR tyrosine kinase inhibitor (TKI). 2. Participants who have previously received ADC therapy containing Top I inhibitors, or other drug therapy targeting the CDH17 target. 3. 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). 4. Related AEs from prior therapy (except for alopecia and ≤Grade 2 sensory neuropathy) have not recovered to ≤Grade 1 or baseline level. 5. Known weight loss of \>10% within 2 months before the first dose of study drug or other indicators showing severe malnutrition. 6. 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. 7. Participants with current imaging or clinical evidence of significant gastrointestinal obstruction. 8. Participants with clinically significant bleeding symptoms within 1 month before the first IMP dose. 9. Participants with known active CNS metastasis. 10. Participants with cardiovascular/cerebrovascular disorder, symptoms, or manifestations. 11. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Tolerated Dose (MTD) | 30 days after the last dose of IMP] | The MTD will be determined using DLTs |
| Recommended Phase 2 Dose (RP2D) | 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 | 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) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tmax | 30 days after the last dose of IMP] | Time to reach the maximum blood concentration |
| Cmax | 30 days after the last dose of IMP | Maximum observed blood concentration |
| Incidence of anti-drug antibody (ADA) | 30 days after the last dose of IMP | The proportion of patients with positive ADA results |
| Disease control rate (DCR) | 30 days after the last dose of IMP | DCR is defined as the proportion of subjects with response of CR, PR and SD (based on RECIST Version 1.1) |
| Duration of Response (DoR) | 30 days after the last dose of IMP | The time from first documented evidence of CR or PR until time of first documented disease progression. |
| Progression Free Survival (PFS) | 30 days after the last dose of IMP | PFS is defined as the interval between first dose and the earliest date of disease progression or death due to any cause |
| Overall survival (OS) | 30 days after the last dose of IMP | OS is defined as the time from first dose until death due to any cause |
Countries
China
Contacts
CONTACTRuichao Zeng
Outcome results
None listed