NCT05278832

Brief Summary

This is a multi-center, open-label design to evaluate the safety and tolerance of QLS31905 in patients with advanced solid tumors, together with an assessment of pharmacokinetic characteristics and efficacy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
104

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2021

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

October 25, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 14, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 14, 2022

Status Verified

March 1, 2022

Enrollment Period

1.2 years

First QC Date

February 23, 2022

Last Update Submit

March 3, 2022

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

  • Dose limiting toxicities(DLTs)

    Number of participants experiencing DLTs According to NCI-CTCAE v.5.0，To evaluate the safety and tolerability of QLS31905

    2 years

  • Maximum tolerated Dose(MTD)

    To evaluate the safety and tolerability of QLS31905

    2 years

Secondary Outcomes (6)

  • Progression-free Survival (PFS)

    2 years

  • Objective response rate (ORR)

    2 years

  • Disease control rate (DCR)

    2 years

  • adverse events (AE)

    2 years

  • Cmax

    2 years

  • +1 more secondary outcomes

Study Arms (1)

QLS31905

EXPERIMENTAL

QLS31905 injection

Drug: QLS31905

Interventions

QLS31905DRUG

QLS31905 injection

QLS31905

Eligibility Criteria

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

You may qualify if:

  • Written informed consent.
  • ≥18 years.
  • Female or male.
  • ECOG performance status score 0 or 1.
  • Histologically or cytologically confirmed diagnosis of advanced solid tumors.
  • Adequate haematological, hepatic and renal function.

You may not qualify if:

  • Any anticancer therapy or immunotherapy within 4 weeks prior to the start of study treatment.
  • Untreated or symptomatic central nervous system (CNS) metastases or leptomeningeal disease.
  • Patients with a history of monoclonal antibody allergic reaction.
  • Known human immunodeficiency virus infection or known symptomatic hepatitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

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

February 23, 2022

First Posted

March 14, 2022

Study Start

October 25, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

March 14, 2022

Record last verified: 2022-03

Locations

CN(1)