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

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

An Open-Label, Multicenter, Dose Escalation And Expansion Study Of SHR-1916 In Subjects With Locally Advanced Or Metastatic Solid Tumor Malignancies

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04842630
• Other study ID #: SHR-1916-I-101
• Status: Terminated
• Phase: Phase 1
• Start date: April 8, 2021
• Est. completion date: November 1, 2022

Study information

• Verified date: February 2024
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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-a)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.

Related Conditions & MeSH terms

• Neoplasms
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Drug:
• SHR-1916
All participants receive SHR-1906 alone

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Limited Toxicity (DLT)		21 Days (first cycle)
Primary	Maximum tolerable dose (MTD)		21 Days (first cycle)
Primary	Recommended dose for phase II (RP2D)		Up to 8 months
Secondary	AEs (Adverse Events)		30 days after last dose
Secondary	Area under the plasma concentration time curve in the dosing interval AUC(TAU) of SHR-1916		30 days after last dose
Secondary	Maximum observed plasma concentration (Cmax) of SHR-1916		30 days after last dose
Secondary	Minimum observed plasma concentration (Cmin) of SHR-1916		30 days after last dose
Secondary	Time of maximum observed plasma concentration (Tmax) of SHR-1916		30 days after last dose
Secondary	Percentage of NK cell and CD8+ T cell by flow cytometry		30 days after last dose
Secondary	Absolute count values of NK cell and CD8+ T cell by flow cytometry		30 days after last dose
Secondary	Peripheral plasma concentration of sCD25		30 days after last dose
Secondary	Immunogenicity analysis to assess anti-drug antibodies (ADA) to SHR-1916 in human serum		30 days after last dose
Secondary	ORR(Objective Response Rate)		at the time point of every 9 weeks
Secondary	DCR(Disease Control Rate)		at the time point of every 9 weeks
Secondary	DoR(Duration of Response)		up to 2 years
Secondary	PFS(Progression-Free-Survival)		up to 2 years
Secondary	12-month-survival Rate		up to 2 years