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

NCT04842630 | Terminated Phase 1

• 1 other identifier: SHR-1916-I-101
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Dose Limited Toxicity (DLT)

  21 Days (first cycle)

• Maximum tolerable dose (MTD)

  21 Days (first cycle)

• Recommended dose for phase II (RP2D)

  Up to 8 months

Secondary Outcomes (14)

• AEs （Adverse Events）

  30 days after last dose

• Area under the plasma concentration time curve in the dosing interval AUC(TAU) of SHR-1916

  30 days after last dose

• Maximum observed plasma concentration (Cmax) of SHR-1916

  30 days after last dose

• Minimum observed plasma concentration (Cmin) of SHR-1916

  30 days after last dose

• Time of maximum observed plasma concentration (Tmax) of SHR-1916

  30 days after last dose

Study Arms (1)

SHR-1916

EXPERIMENTAL

Drug: SHR-1916

Interventions

SHR-1916 DRUG

All participants receive SHR-1906 alone

SHR-1916

Eligibility Criteria

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

You may qualify if:

• Ability to understand and the willingness to sign a written informed consent document；
• Aged between 18-75 years old;
• Histologically or cytologically confirmed advanced or metastatic malignant tumor;
• Presence of at least of one measurable lesion in agreement to RECIST criteria;
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;
• Life expectancy \>12 weeks;
• Adequate organ performance based on laboratory blood tests;
• Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.

You may not qualify if:

• Patients who have received cytokines (IL-2, IFN-α)as anti-tumor therapy within 6 months before the first dose;
• Previous systemic therapy within 28 days before the first dose;
• Previous therapeutic surgery within 28 days, and diagnostic surgery within 14 days prior to the first dose;
• Received live attenuated vaccine within 28 days before the first dose, or expected to receive live attenuated vaccine during the study treatment period;
• Patients who received systemic immunosuppressive therapy within 14 days before the first dose;
• Patients with known or suspected brain metastasis；
• 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;
• Patients with history of autoimmune diseases;
• History of immunodeficiency (including HIV infection) or organ transplantation;
• Known active hepatitis B or C infection;
• Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

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: April 1, 2021
• First Posted: April 13, 2021
• Study Start: April 8, 2021
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: February 9, 2024

Record last verified: 2024-02

Locations

CN (1)