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

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • HDM2017
  • Fruquintinib

Treatment groups

120 Participants
are divided into 1 treatment group