Health TrialsbyHealthPanel

A Study of HDM2017 Combination Therapy in Advanced Colorectal Cancer

ConditionCRC, Colorectal Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

220 Participants
are divided into 3 treatment groups
Group A: HDM2017 + bevacizumab + oxaliplatin + leucovorin + fluorouracilExperimental treatment 5 interventions
Group B: HDM2017 + bevacizumab + leucovorin + fluorouracilExperimental treatment 4 interventions
Group C: HDM2017 + bevacizumab + oxaliplatin + capecitabineExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Maximum Tolerated Dose (MTD)

The MTD will be determined using DLTs

Time frame
30 days after the last dose of IMP
2

Recommended Phase 2 Dose (RP2D)

The RP2D will be determined using dose limiting toxicities (DLTs) and all other available study data

Time frame
30 days after the last dose of IMP
3

Type, incidence and severity of Adverse Events

Safety and tolerability profile assessed by the Common Terminology Criteria for Adverse Events v6.0

Time frame
30 days after the last dose of IMP
4

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).

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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