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A Study of HDM2017 Combination Therapy in Advanced Colorectal Cancer

NCT07805551 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2026-09-04

No results posted yet for this study

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

Interventions

DRUG

HDM2017

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

DRUG

Bevacizumab

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

DRUG

Oxaliplatin

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

DRUG

Fluorouracil

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

DRUG

Capecitabine

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

DRUG

Leucovorin

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

Sponsors & Collaborators

  • Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-18
Primary Completion
2030-08-31
Completion
2032-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07805551 on ClinicalTrials.gov