SHR-1701 in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma

NCT04282070 | Unknown Phase 1

• 1 other identifier: SHR-1701-I-103
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label, phase Ib Study of SHR-1701 in patients with recurrent/metastatic nasopharyngeal carcinoma(R/M NPC).

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Toxicity Toxicity

  Number of participants with adverse events as assessed by CTCAE v5.0

  up to 2 years

Secondary Outcomes (5)

• Objective Response Rate (ORR) per RECIST 1.1

  up to 2 years

• Progression-free Survival (PFS) per RECIST 1.1

  up to 2 years

• Disease Control Rate (DCR) per RECIST 1.1

  up to 2 years

• Immunogenicity of SHR-1701

  up to 2 years

• Overall Survival (OS)

  up to 2 years

Study Arms (4)

SHR-1701 (Arm A)

EXPERIMENTAL

SHR-1701 for R/M NPC failure after platinum-based chemotherapy

Drug: SHR-1701

SHR-1701 (Arm B)

EXPERIMENTAL

SHR-1701 for R/M NPC failure after anti PD-1/PD-L1 antibody therapy

Drug: SHR-1701

SHR-1701 plus Gemcitabine and Cisplatin (Arm C)

EXPERIMENTAL

SHR-1701+Gemcitabine+Cisplatin for first line treatment of R/M NPC

Drug: SHR-1701; Drug: Gemcitabine; Drug: Cisplatin

SHR-1701 plus Albumin Paclitaxel (Arm D)

EXPERIMENTAL

SHR-1701+Albumin Paclitaxel for R/M NPC failure after first line anti PD-1/PD-L1 antibody therapy

Drug: SHR-1701; Drug: Albumin Paclitaxel

Interventions

SHR-1701 DRUG

Subjects will receive an intravenous infusion of SHR-1701 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the trial.

Also known as: SHR-1701 Injection

SHR-1701 (Arm A); SHR-1701 (Arm B); SHR-1701 plus Albumin Paclitaxel (Arm D); SHR-1701 plus Gemcitabine and Cisplatin (Arm C)

Gemcitabine DRUG

Maximum 6 cycles for combined therapy.

Also known as: Gemcitabine Hydrochloride for Injection

SHR-1701 plus Gemcitabine and Cisplatin (Arm C)

Cisplatin DRUG

Maximum 6 cycles for combined therapy.

Also known as: Cisplatin Injection

SHR-1701 plus Gemcitabine and Cisplatin (Arm C)

Albumin Paclitaxel DRUG

Maximum 6 cycles for combined therapy.

Also known as: nab-Paclitaxel

SHR-1701 plus Albumin Paclitaxel (Arm D)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed Recurrent/Metastatic Nasopharyngeal Carcinoma
• Subjects failure after platinum-based chemotherapy; failure from anti-PD-1/PD-L1 antibody therapy; Primarily metastatic (stage IVB as defined by the International Union against Cancer and American Joint Committee on Cancer staging system for NPC, eighth edition) or recurrent NPC that is not amenable for local regional treatment or curative treatment; failure from first line anti-PD-1/PD-L1 antibody therapy.
• Able and willing to provide signed informed consent form, and able to comply with all procedures.
• Histologically or cytologically proven metastatic or locally advanced solid tumors.
• Life expectancy \>= 12 weeks as judged by the Investigator.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry.
• Disease must be measurable with at least 1 uni dimensional measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

You may not qualify if:

• Prior therapy with an anti-PD1, anti-PD-L1, anti-CTLA-4 or a TGFb inhibitor.
• Anticancer treatment within 28 days before the first dose of study drug.
• Major surgery within 28 days before start of trial treatment.
• Systemic therapy with immunosuppressive agents within 7 days prior to the first dose of study drug; or use any investigational drug within 28 days before the start of trial treatment.
• With any active autoimmune disease or history of autoimmune disease.
• With active central nervous system (CNS) metastases causing clinical symptoms or requiring therapeutic intervention.
• Clinically significant cardiovascular and cerebrovascular diseases
• History of immunodeficiency including seropositive for human immunodeficiency virus (HIV), or other acquired or congenital immunedeficient disease, or any active systemic viral infection requiring therapy.
• Previous malignant disease (other than the target malignancy to be investigated in the trial) within the last 2 years. Subjects with history of cervical carcinoma in situ, superficial or non-invasive bladder cancer or basal cell or squamous cell cancer in situ previously treated with curative intent are NOT excluded.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Cancer Hospital of Guangzhou Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

SHR-1701; Gemcitabine; Injections; Cisplatin; 130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Drug Administration Routes; Drug Therapy; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 24, 2020
• Study Start: March 27, 2020
• Primary Completion: April 16, 2022
• Study Completion: December 15, 2022
• Last Updated: December 21, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)