NCT03722186

Brief Summary

SHR-1603-I-101 is an single-arm, open-label, dose finding phase I clinical trial of SHR-1603 in subjects with advanced solid tumor or relapsed/refractory malignant lymphoid diseases. The study drug will be administered by intravenous infusion.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
128

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2018

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 26, 2018

Completed
18 days until next milestone

Study Start

First participant enrolled

November 13, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2019

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

March 22, 2021

Status Verified

March 1, 2021

Enrollment Period

5 months

First QC Date

October 25, 2018

Last Update Submit

March 18, 2021

Conditions

Physiological Effects of DrugsNeoplasms by Histologic TypeLymphomaHematologic NeoplasmsImmunotherapyAdvanced Cancer

Keywords

advanced solid tumorR/R lymphoma

Outcome Measures

Primary Outcomes (3)

  • Adverse events(AE) of SHR-1603

    Assessment of the incidence of treatment-emergent AEs

    18 months (anticipated)

  • Dose-limited toxicity (DLT) of SHR-1603

    Assessment of the incidence of DLT

    18 months(anticipated)

  • Maximum tolerated dose (MTD) of SHR-1603

    The highest dosing level at which no more than 1 of 6 patients has DLT

    18 months(anticipated)

Secondary Outcomes (11)

  • The peak plasma concentration (Cmax) of SHR-1603

    18 months (anticipated)

  • The area under the plasma concentration versus time curve (AUC) of SHR-1603

    18 months (anticipated)

  • The half-life(t1/2) of SHR-1603

    18 months (anticipated)

  • The objective response rate(ORR) in subjects with advanced tumors treated with SHR-1603

    36 months

  • The best of response (BOR) in subjects with advanced tumors treated with SHR-1603

    36 months

  • +6 more secondary outcomes

Study Arms (1)

SHR-1603

EXPERIMENTAL

Multiple escalating doses of SHR-1603

Drug: SHR-1603

Interventions

SHR-1603DRUG

SHR-1603 monotherapy

SHR-1603

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 18 years or older;
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
  • Life expectancy no less than 12 weeks;
  • Pathologically confirmed advanced solid tumor or relapsed/refractory lymphoma with measurable target lesions;
  • Adequate bone marrow, haptic, renal and coagulation function.

You may not qualify if:

  • Evidence of central nervous system (CNS) involvement;
  • Previously treated with similar agents;
  • History of anticancer treatment within 4 weeks of enrollment (6 weeks for subjects treated with nitrosoureas or mitomycins);
  • Anticipated to be involved in other anti-cancer treatments expect for palliative care during the trial;
  • History of anti-cancer vaccination; or history of vaccination using attenuated vaccines within 4 weeks of enrollment;
  • History of Red blood cell (RBC) transfusion within or treatment with erythropoitin(EPO) within 3 months of enrollment;
  • History of grade 3 or higher thrombolic incidence within 2 years of enrollment, or using antithrombotic/anticoagulant agents;
  • With confirmed immunodeficiency, uncontrolled auto-immune disease, uncontrolled cardiovascular disease, uncontrolled or active infection;
  • Substance abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200120, China

Location

MeSH Terms

Conditions

Neoplasms by Histologic TypeLymphomaHematologic Neoplasms

Condition Hierarchy (Ancestors)

NeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms by SiteHematologic Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2018

First Posted

October 26, 2018

Study Start

November 13, 2018

Primary Completion

April 4, 2019

Study Completion

October 1, 2021

Last Updated

March 22, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)