RecruitingPhase 1Phase 2NCT07805551

A Study of HDM2017 Combination Therapy in Advanced Colorectal Cancer

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


Sponsor

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Enrollment

220 participants

Start Date

Aug 18, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Bevacizumab, a drug called Capecitabine, and others for people with crc (colorectal cancer). The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHDM2017

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

DRUGBevacizumab

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

DRUGOxaliplatin

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

DRUGFluorouracil

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

DRUGCapecitabine

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

DRUGLeucovorin

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


Locations(1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

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NCT07805551


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