A Phase 1 Dose Escalation and Expansion Study Of SHR-1916 In Subjects With Locally Advanced Or Metastatic Solid Tumors

NCT ID: NCT04842630

Last Updated: 2024-02-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-08
• Study Completion Date: 2022-11-01

Brief Summary

This is a first in human, open-label, dose escalation and expansion Phase 1 study of SHR-1916 in adult patients with locally advanced or metastatic solid tumors.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SHR-1916

Group Type: EXPERIMENTAL

SHR-1916

Intervention Type: DRUG

All participants receive SHR-1906 alone

Interventions

SHR-1916

All participants receive SHR-1906 alone

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Ability to understand and the willingness to sign a written informed consent document；

2. Aged between 18-75 years old;

3. Histologically or cytologically confirmed advanced or metastatic malignant tumor;

4. Presence of at least of one measurable lesion in agreement to RECIST criteria;

5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;

6. Life expectancy >12 weeks;

7. Adequate organ performance based on laboratory blood tests;

8. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.

Exclusion Criteria

1. Patients who have received cytokines (IL-2, IFN-α)as anti-tumor therapy within 6 months before the first dose;

2. Previous systemic therapy within 28 days before the first dose;

3. Previous therapeutic surgery within 28 days, and diagnostic surgery within 14 days prior to the first dose;

4. Received live attenuated vaccine within 28 days before the first dose, or expected to receive live attenuated vaccine during the study treatment period;

5. Patients who received systemic immunosuppressive therapy within 14 days before the first dose;

6. Patients with known or suspected brain metastasis；

7. Subjects with interstitial pneumonia or interstitial lung disease, with a history of interstitial pneumonia or interstitial lung disease limiting self care ADL or with life-threatening respiratory compromise, with a history of pulmonary fibrosis, lasting pneumonia, drug- or radiation-induced pneumonia, and congenital pneumonia that may otherwise interfere with the judgement of immune-related pulmonary toxicity, or with any evidence of active pneumonia as shown on chest CT scans;

8. Patients with history of autoimmune diseases;

9. History of immunodeficiency (including HIV infection) or organ transplantation;

10. Known active hepatitis B or C infection;

11. Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

SHR-1916-I-101

Identifier Type: -

Identifier Source: org_study_id