A Study of HDM2017 Combination Therapy in Advanced Colorectal Cancer

NCT07805551 | Recruiting Phase 1 DMC

• 1 other identifier: HDM2017-202
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

HDM2017; CRC

Outcome Measures

Primary Outcomes (4)

• Maximum Tolerated Dose (MTD)

  The MTD will be determined using DLTs

  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

  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

  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).

  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)

  30 days after the last dose of IMP

• Duration of Response (DoR)

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

• Progression Free Survival (PFS)

  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)

  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)

  30 days after the last dose of IMP

Study Arms (3)

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

Interventions

HDM2017 DRUG

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

HDM2017 + bevacizumab + leucovorin + fluorouracil; HDM2017 + bevacizumab + oxaliplatin + capecitabine; HDM2017 + bevacizumab + oxaliplatin + leucovorin + fluorouracil

Oxaliplatin DRUG

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

HDM2017 + bevacizumab + oxaliplatin + capecitabine; HDM2017 + bevacizumab + oxaliplatin + leucovorin + fluorouracil

Capecitabine DRUG

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

HDM2017 + bevacizumab + oxaliplatin + capecitabine

Leucovorin DRUG

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

HDM2017 + bevacizumab + leucovorin + fluorouracil; HDM2017 + bevacizumab + oxaliplatin + leucovorin + fluorouracil

Bevacizumab DRUG

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

HDM2017 + bevacizumab + leucovorin + fluorouracil; HDM2017 + bevacizumab + oxaliplatin + capecitabine; HDM2017 + bevacizumab + oxaliplatin + leucovorin + fluorouracil

Fluorouracil DRUG

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

HDM2017 + bevacizumab + leucovorin + fluorouracil; HDM2017 + bevacizumab + oxaliplatin + leucovorin + fluorouracil

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Bevacizumab; Oxaliplatin; Fluorouracil; Capecitabine; Leucovorin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Central Study Contacts

Lin Shen

CONTACT

010-88196561; doctorshenlin@sina.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: September 4, 2026
• Study Start: August 18, 2026
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2032
• Last Updated: September 4, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)