NCT05652894|RecruitingPhase 3

A Study of HX008 Compared to Chemotherapy in the First-Line Treatment of Subjects With MSI-H/dMMR Metastatic Colorectal Cancer

A Randomized Phase III Study of HX008 (a Humanized Monoclonal Antibody Against PD-1) Compared to Investigator's Choice Chemotherapy in the First-Line Treatment of Subjects With Microsatellite Instability-High (MSI-H)/Deficient DNA Mismatch Repair (dMMR) Metastatic Colorectal Cancer

Taizhou Hanzhong biomedical co. LTD ClinicalTrials.gov

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1 other identifier

HX008-III-CRC-01

Study Type

interventional

Target

190

Locations

1 country

Sites

Timeline

RegisteredDec 2022

StartedFeb 2023

CompletionOct 2028

Brief Summary

The main purpose of this study is to compare the clinical benefit, as measured by Progression-Free Survival (PFS), achieved by HX008 or Investigator's Choice Chemotherapy in participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) metastatic colorectal cancer (mCRC).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

190

participants targeted

Target at P25-P50 for phase_3

Timeline

30mo left

Started Feb 2023

Longer than P75 for phase_3

Geographic Reach

1 country

63 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.6 years study duration

Study Progress57%

Feb 2023Oct 2028

First Submitted

Initial submission to the registry

November 26, 2022

Completed

19 days until next milestone

First Posted

Study publicly available on registry

December 15, 2022

Completed

3 months until next milestone

Study Start

First participant enrolled

February 28, 2023

Completed

3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected

2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2028

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

3.3 years

First QC Date

November 26, 2022

Last Update Submit

April 16, 2026

Conditions

Metastatic Colorectal Cancer

Keywords

Colorectal Neoplasms Intestinal Neoplasms Bevacizumab Cetuximab Irinotecan Oxaliplatin Antibodies Antibodies Monoclonal Antine

Outcome Measures

Primary Outcomes (1)

Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Independent Review Committee(IRC)
PFS, defined as the time from randomization to the first documented disease progression per RECIST 1.1 assessed by IRC or death due to any cause, whichever occurs first.
2 years

Secondary Outcomes (19)

Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Investigators
2 years
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by IRC or investigators
2 years
Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by IRC or investigators
2 years
Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by IRC or investigators
2 years
Overall Survival (OS)
2 years
+14 more secondary outcomes

Study Arms (2)

HX008

EXPERIMENTAL

Subjects receive HX008 200 mg intravenous (IV) every 3 weeks (Q3W)

Drug: HX008

Investigator's Choice Chemotherapy

ACTIVE COMPARATOR

1. mFOLFOX6 2. mFOLFOX6+Bevacizumab 3. mFOLFOX6+Cetuximab 4. FOLFORI 5. FOLFORI+Bevacizumab 6. FOLFORI+Cetuximab 7. CAPEOX 8. CAPEOX+ Bevacizumab

Drug: Investigator's Choice Chemotherapy

Interventions

HX008DRUG

Drug: HX008 200 mg ,Q3W

HX008

Investigator's Choice ChemotherapyDRUG

Drug: bevacizumab 5mg/kg given by IV every 14 days. Other Name: Avastin Drug: cetuximab 400 mg/m2 for the first dose, then 250 mg/sqm, intravenous infusion, repeated weekly; or Cetuximab 500 mg/ sqm, intravenous infusion, D1, repeated every 2 weeks. Other Name: Erbitux Drug: oxaliplatin 85 mg/sqm by IV, day1. Component of mFOLFOX6. Drug: irinotecan 180 mg/sqm by IV, day1.Component of FOLFORI. Drug: calcium Folinate 400 mg/sqm by IV, day1.Component of mFOLFOX6 or FOLFORI. Drug: 5-fluorouracil 400 mg/sqm, day1,followed by 2400 mg/sqm iv infusion over 46\~48 h.Component of mFOLFOX6 or FOLFORI. Drug: oxaliplatin 130 mg/sqm, intravenous infusion over 2 h ± 30 min, Day 1. Component of CAPEOX. Drug: capecitabine 1000 mg/sqm administered orally twice daily, Days 1-14. Component of CAPEOX. Drug: bevacizumab 7.5 mg/kg, intravenous infusion, D1, repeated every 3 weeks

Investigator's Choice Chemotherapy

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Voluntarily sign the Informed Consent Form（ICF）, understand the study, be willing to follow and be able to complete all test procedures;
Male or female, age ≥ 18 years on the day of signing the informed consent form;
Histologically or cytologically confirmed adenocarcinoma of the colon or rectum, classified as Stage IV according to the AJCC (8th edition, 2017) TNM staging system for colorectal cancer;
Confirmed MSI-H/dMMR status by the central laboratory;
No prior systemic treatment for metastatic colorectal cancer; subjects received neoadjuvant/adjuvant therapy with disease progression should be completed \> 6 months prior to the neoadjuvant/adjuvant therapy were enrolled.
Has at least one measurable extracranial lesion (Lesions with the longest diameter ≥ 10mm, or lymph nodes with a short diameter ≥ 15mm) according to Response Evaluation Criteria in Solid Tumors Version 1.1(RECIST1.1), which has not been treated with local treatment(Lesions located in the area of previous radiation therapy can also optional if the progression is confirmed);
Eastern Cooperative Oncology Group (ECOG) of 0 or 1;
Estimated life expectancy of ≥12 weeks;
Absolute neutrophil count (ANC)≥1.5×10\^9/L
White blood cell count (WBC)≥3×10\^9/L
Platelet count (PLT)≥100×10\^9/ L
Hemoglobin (HGB)≥90 g/L
Serum creatinine (Scr) ≤1.5×ULN
Alanine aminotransferase (ALT) 、Aspartate aminotransferase (AST) ≤2.5× (upper limit of normal, ULN) . Patients with liver metastases require ALT and AST≤5×ULN,
TBIL≤1.5×ULN
+3 more criteria

You may not qualify if:

Prior systemic treatment for metastatic colorectal cancer (subjects who received neoadjuvant/adjuvant therapy with disease progression should be completed \> 6 months prior to the neoadjuvant/adjuvant therapy were enrolled.)
Subjects diagnosed with any other malignancy within 5 years prior to randomization, except for malignancies with a low risk of metastasis and death (5-year survival rate \> 90%), such as adequately basal cell or squamous cell skin cancer or carcinoma in situ of the cervix and other carcinomas in situ;
Had prior treatment with any anti-PD-1, anti-PD-L1, PD-L2, or CTLA-4 agent or any other drug targeting T cell co-stimulation or immune checkpoint pathway;
Has active autoimmune disease (except for psoriasis), that has required systemic treatment in the past 2 years((eg, corticosteroids or immunosuppressive drugs). Except for alternative therapies (eg, thyroxine, insulin or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency);
Need to receive systemic corticosteroids (dose equivalent to \> 10 mg prednisone/day) or other immunosuppressive drugs within 14 days before enrollment or during the study period. Those under the following conditions are eligible:
Locally external use or inhaled corticosteroids;
short-term (≤ 7 days) use of glucocorticoids for the prevention or treatment of nonautoimmune allergic diseases;
Has had prior radiation therapy or has not recovered (≤ Grade 1 or at Baseline) from Adverse events(AEs) due to a previous radiation therapy;
Has received a significant surgery, open biopsy, or severe trauma within 4 weeks prior to randomization; Definition of major surgery: the minimum of 3 weeks of post-operative recovery time is required to undergo this study, any wound-related AE must be resolved prior to randomization;
Has severe infection within 4 weeks or active infection requiring IV infusion or oral administration of antibiotics within 2 weeks prior to randomization;
Treatment with investigational products or devices from other clinical trials within 4 weeks prior to randomization;
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis or found during screening;
Has uncontrolled ascites requiring repeated drainage, pleural effusion, or pericardial effusion;
Has incomplete intestinal obstruction, active gastrointestinal hemorrhage, or perforation;
Has a history or current interstitial pneumonia, or current non--infectious pneumonitis treatment with corticosteroids
+8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Taizhou Hanzhong biomedical co. LTDlead

Study Sites (63)

The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, China

RECRUITING

The Fifth Affiliated Hospital of Anhui Medical University

Fuyang, Anhui, China

RECRUITING

Anhui Provincial Cancer Hospital

Hefei, Anhui, China

RECRUITING

Beijing Friendship Hospital, Capital Medical University