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NCT Number: NCT07805551

A Study of HDM2017 Combination Therapy in 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.

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Key information

Conditions

CRC, Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location status: Recruiting

Location contact

Ruichao Zeng

CONTACT

[email protected]

0571-89918267

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

HDM2017

Drug

Administered with continuing until protocol-specified criteria for treatment discontinuation are met

Bevacizumab

Drug

administered with continuing until protocol-specified criteria for treatment discontinuation are met

Oxaliplatin

Drug

administered with continuing until protocol-specified criteria for treatment discontinuation are met

Fluorouracil

Drug

administered with continuing until protocol-specified criteria for treatment discontinuation are met

Capecitabine

Drug

administered with continuing until protocol-specified criteria for treatment discontinuation are met

Leucovorin

Drug

administered with dosing continuing until protocol-specified criteria for treatment discontinuation are met

Primary outcomes

  1. Maximum Tolerated Dose (MTD)

    Time frame: 30 days after the last dose of IMP

    The MTD will be determined using DLTs

  2. 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

  3. 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

  4. 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).

Secondary outcomes

  1. Disease control rate (DCR)

    Time frame: 30 days after the last dose of IMP

  2. Duration of Response (DoR)

    Time frame: From date of confirm ORR until the date of first documented progression, assessed up to about 36 months

  3. 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

  4. 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

  5. Incidence of anti-drug antibody (ADA)

    Time frame: 30 days after the last dose of IMP

Study contacts

Contact information is provided by the study sponsor or research team.

Lin Shen

CONTACT

[email protected]

010-88196561

Sponsors and collaborators

Lead sponsor

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2030
Study completion
2032
First posted
Sep 4, 2026
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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