Clinical trial NCT04842630: A Phase 1 Dose Escalation and Expansion Study Of SHR-1916 In Subjects With Locally Advanced Or Metastatic Solid Tumors
Official title: An Open-Label, Multicenter, Dose Escalation And Expansion Study Of SHR-1916 In Subjects With Locally Advanced Or Metastatic Solid Tumor Malignancies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-04-13
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

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