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Not yet recruiting NCT07621159

A Phase Ib/II Study of HDM2017 in Combination With Standard of Care in Advanced Colorectal Cancer

Phase I / Phase II Interventional Colorectal Cancer Metastatic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HDM2017, Fruquintinib.
Who it may be relevant to
Registry conditions: Colorectal Cancer Metastatic. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

  • Drug HDM2017
    Following a predefined dose and date.
  • Drug Fruquintinib
    Following a predefined dose and date.

Primary outcome measures

  • Maximum Tolerated Dose (MTD) [Time frame: 30 days after the last dose of IMP]]
  • Recommended Phase 2 Dose (RP2D) [Time frame: 30 days after the last dose of IMP]
  • Type, incidence and severity of Adverse Events [Time frame: 30 days after the last dose of IMP]
  • Objective Response Rate (ORR) [Time frame: 30 days after the last dose of IMP]
Secondary outcome measures (7)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

  • 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.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking University Cancer Hospital — Beijing

Identifiers

NCT: NCT07621159 · HDM2017-201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗