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

Hengrui Medicine

Status and phase: Terminated; Phase 1

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Treatments: Drug: SHR-1916

Study type: Interventional

Funder types: Industry

Identifiers

NCT04842630

SHR-1916-I-101

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

SHR-1916

Experimental group

Treatment:

Drug: SHR-1916