Study of HX008 for the Treatment of Anaplastic Thyroid Cancer (ATC)

NCT04574817 | Unknown Phase 2

• 1 other identifier: HX008-II-ATC-01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

There are currently no target therapies approved for treatment of anaplastic thyroid cancer (ATC), leading to a clear need for improving therapy for ATC. This is a single-arm, multicenter study to evaluate the efficacy and safety of HX008 injection in patients with metastatic or locally advanced anaplastic thyroid cancer.

Conditions

Anaplastic Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Percentage of subjects achieving complete response (CR) and partial response (PR)

  Up to approximately 30 months

Secondary Outcomes (5)

• Disease Control Rate (DCR)

  Up to approximately 30 months

• Duration of Response (DOR)

  Up to approximately 30 months

• Progression-free Survival (PFS)

  Up to approximately 30 months

• Overall Survival (OS)

  Up to approximately 30 months

• Adverse Effect (AE)

  Up to approximately 30 months

Study Arms (1)

HX008

EXPERIMENTAL

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

Drug: HX008

Interventions

HX008 DRUG

200 mg administered as IV infusion on Day 1 of each 21-day cycle.

HX008

Eligibility Criteria

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

You may qualify if:

• Be willing and able to provide written informed consent for the trial.
• Age ≥ 18 years old, male or female.
• Subjects must have histological diagnosis of inoperative IVB or IVC stage anaplastic thyroid cancer.
• Prior neoadjuvant, adjuvant or palliative chemotherapy for ATC is allowed, there is no limit to the number of prior lines of treatment a patient has received.
• Have measurable disease based on RECIST 1.1.
• Willing to provide tissue for PD-L1 biomarker analysis.
• Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Score.
• Life expectancy ≥ 3 months.
• Has adequate organ function as defined in the protocol.
• Female subject of childbearing potential should have a negative serum pregnancy within 72 hours prior to receiving the first dose of study treatment.
• Male and female participants should agree to use an adequate method of contraception during the experiment and 6 months after the last administration of the test drugs.

You may not qualify if:

• Subjects who are suitable or intent to receive local treatment.
• Differentiated thyroid cancer (DTC) or medullary thyroid cancer (MTC). ATC arising out of DTC is allowed, as long as the measurable disease is clinically consistent with ATC i.e., rapidly progressive and/or 18F fluorodeoxyglucose (FDG)-avid.
• Subjects diagnosed with any other malignancy within 3 years prior to the first dose of HX008, except for malignancies with a low risk of metastasis and death (5-year survival rate \> 90%), such as basal cell or squamous cell skin cancer or carcinoma in situ of the cervix and other carcinomas in situ.
• Has had a prior anti-cancer monoclonal antibody within 4 weeks prior to the first dose of trial treatment or who has not recovered (≤ Grade 1 or at Baseline) from AEs due to agents administered more than 4 weeks earlier.
• Has had prior chemotherapy, radiation therapy or targeted small molecular therapy within 2 weeks prior to the first dose of trial treatment or who has not recovered (≤ Grade 1 or at Baseline) from AEs due to a previously administrated agent.
• Has had prior herbal medicine within 1 week prior to the first dose of trial treatment.
• Has received prior therapy with an anti-PD-1, or anti-PD-L1, or anti-CTLA-4 agents.
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Has active autoimmune disease that has required systemic treatment in past 2 years.
• Has received a major surgery within 4 weeks prior to the first dose of trial treatment.
• Has received system treatment with corticosteroids (dose \>10mg/day prednison or other therapeutic hormones) within 2 weeks prior to the first dose of trial treatment.
• Has a history of interstitial lung disease.
• Has uncontrolled cardiovascular disease, including but not limited to: 1) heart failure greater than New York Heart Association (NYHA) class II; 2) unstable angina pectoris; 3) has myocardial infarction within 1 year; 4) supraventricular or ventricular arrhythmias with clinical significance.
• Has uncontrolled systemic disease, such as diabetes or hypertension.
• Has a history of active tuberculosis.

Sponsors & Collaborators

• Taizhou Hanzhong biomedical co. LTD: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

MeSH Terms

Conditions

Thyroid Carcinoma, Anaplastic

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Yuankai Shi

CONTACT

010-87788293; syuankai@cicams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 5, 2020
• Study Start: December 28, 2020
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2023
• Last Updated: October 5, 2020

Record last verified: 2020-09

Locations

CN (1)