SHR-1701 in Metastatic or Locally Advanced Solid Tumors

NCT03710265 | Unknown Phase 1

• 1 other identifier: SHR-1701-I-101
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this Phase I study is to access the safety and tolerability of SHR-1701 at different dose levels. It is hoped to find out the recommended dose for Phase II/III.

Conditions

Solid Tumor

Keywords

SHR-1701; Solid tumor; Metastatic or locally advanced solid tumors

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability profile of SHR-1701

  Number of Subjects who occurs dose-limiting toxicity (DLTs)

  Up to week 3

• Objective Response Rate (ORR) assessed by site investigator as per RECIST 1.1

  Screening up to study completion, an average of 1 year

Secondary Outcomes (15)

• Area under the plasma concentration versus time curve (AUC) of SHR-1701

  Up to 4 weeks after last treatment

• Peak Plasma Concentration (Cmax) of SHR-1701

  Up to 4 weeks after last treatment

• Half-time (t1/2) of SHR-1701

  Up to 4 weeks after last treatment

• Pharmacodynamic features of SHR-1701

  12 months (anticipated)

• Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors

  12 months (anticipated)

Study Arms (1)

SHR-1701

EXPERIMENTAL

Drug: SHR-1701

Interventions

SHR-1701 DRUG

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

SHR-1701

Eligibility Criteria

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

You may qualify if:

• Male or female subjects aged between 18 and 75 years
• Life expectancy \>= 12 weeks as judged by the Investigator
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
• Has measurable disease per RECIST 1.1
• Subjects with confirmed metastatic or locally advanced solid tumor (histologically or cytologically) and there is no known effective anti-tumor treatment (refractory or relapsed from standard treatment).
• Adequate hematological, hepatic and renal function as defined in the protocol
• Females of childbearing potential (FOCBP), who are not surgically sterile or postmenopausal, must conduct pregnancy test (serum or urine) within 7 days before enrollment, and must not be pregnant or breast-feeding women. If the result is negative, she must agree to use adequate contraception during the experiment and 3 months after the last administration of the test drugs. And non-sterilized males who are sexually active must agree to use adequate contraception during the experiment and 3 months after the last administration of the test drugs.
• Able to understand and sign an informed consent, and able to comply with all procedures

You may not qualify if:

• Anticancer treatment within 28 days before the first dose of study drug
• Major surgery within 28 days before start of trial treatment (prior diagnostic biopsy is permitted)
• 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, including but not limited to the following: hepatitis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded
• Subjects with active central nervous system (CNS) metastases causing clinical symptoms or metastases that require therapeutic intervention are excluded
• Clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class \> 2), or ventricular arrhythmia which need medical intervention.
• History of immunodeficiency including seropositive for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease, or any active systemic viral infection requiring therapy, e.g., hepatitis B or C
• 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.
• Receipt of any organ transplantation, including allogeneic stem-cell transplantation

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

RECRUITING

Related Publications (1)

• Liu D, Zhou J, Wang Y, Li M, Jiang H, Liu Y, Yin X, Ge M, Xiang X, Ying J, Huang J, Zhang YQ, Cheng Y, Huang Z, Yuan X, Han W, Yan D, Wang X, Liu P, Wang L, Zhang X, Luo S, Liu T, Shen L. Bifunctional anti-PD-L1/TGF-betaRII agent SHR-1701 in advanced solid tumors: a dose-escalation, dose-expansion, and clinical-expansion phase 1 trial. BMC Med. 2022 Oct 25;20(1):408. doi: 10.1186/s12916-022-02605-9.

  PMID: 36280870 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

SHR-1701

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lin Shen, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linna Wang, MD

CONTACT

+86-10-67166319; Linna.wang@hengrui.com

Study Design

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

Study Record Dates

• First Submitted: October 14, 2018
• First Posted: October 18, 2018
• Study Start: November 20, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: November 22, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)