NCT07038005

Brief Summary

This study includes two cohorts, respectively evaluating safety, tolerability and preliminary efficacy of intravenous and subcutaneous administration of SPGL008.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P75+ for phase_1

Timeline
14mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress42%
Jul 2025Jun 2027

First Submitted

Initial submission to the registry

June 17, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 26, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

July 30, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2026

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2027

Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

1.1 years

First QC Date

June 17, 2025

Last Update Submit

February 5, 2026

Conditions

Advanced Malignant Tumors

Outcome Measures

Primary Outcomes (2)

  • Dose Limiting Toxicity (DLT)

    DLT will be defined as toxicities that meet pre-defined severity criteria(according to the NCI CTCAE v5.0 toxicity assessment criteria), and assessed as having a suspected relationship to study drug that occurred within the first cycle(21 days) of treatment.

    During the first cycle. Each cycle is 21 days

  • Maximum tolerated dose (MTD)

    MTD was defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.

    During the first cycle. Each cycle is 21 days

Secondary Outcomes (5)

  • Objective Response Rate (ORR)

    Up to 2 years

  • Cmax

    Up to 2 years

  • Tmax

    Up to 2 years

  • T1/2

    Up to 2 years

  • AUC

    Up to 2 years

Study Arms (14)

dose level 1 of SPGL008 （Intravenous administration）

EXPERIMENTAL
Drug: SPGL008

dose level 2 of SPGL008 （Intravenous administration）

EXPERIMENTAL
Drug: SPGL008

dose level 3 of SPGL008 （Intravenous administration）

EXPERIMENTAL
Drug: SPGL008

dose level 4 of SPGL008 （Intravenous administration）

EXPERIMENTAL
Drug: SPGL008

dose level 5 of SPGL008 （Intravenous administration）

EXPERIMENTAL
Drug: SPGL008

dose level 6 of SPGL008 （Intravenous administration）

EXPERIMENTAL
Drug: SPGL008

dose level 7 of SPGL008 （Intravenous administration）

EXPERIMENTAL
Drug: SPGL008

dose level 8 of SPGL008 （Intravenous administration）

EXPERIMENTAL
Drug: SPGL008

dose level 1 of SPGL008 （Subcutaneous administration）

EXPERIMENTAL
Drug: SPGL008

dose level 2 of SPGL008 （Subcutaneous administration）

EXPERIMENTAL
Drug: SPGL008

dose level 3 of SPGL008 （Subcutaneous administration）

EXPERIMENTAL
Drug: SPGL008

dose level 4 of SPGL008 （Subcutaneous administration）

EXPERIMENTAL
Drug: SPGL008

dose level 5 of SPGL008 （Subcutaneous administration）

EXPERIMENTAL
Drug: SPGL008

dose level 6 of SPGL008 （Subcutaneous administration）

EXPERIMENTAL
Drug: SPGL008

Interventions

SPGL008DRUG

Biological product

dose level 1 of SPGL008 （Intravenous administration）dose level 1 of SPGL008 （Subcutaneous administration）dose level 2 of SPGL008 （Intravenous administration）dose level 2 of SPGL008 （Subcutaneous administration）dose level 3 of SPGL008 （Intravenous administration）dose level 3 of SPGL008 （Subcutaneous administration）dose level 4 of SPGL008 （Intravenous administration）dose level 4 of SPGL008 （Subcutaneous administration）dose level 5 of SPGL008 （Intravenous administration）dose level 5 of SPGL008 （Subcutaneous administration）dose level 6 of SPGL008 （Intravenous administration）dose level 6 of SPGL008 （Subcutaneous administration）dose level 7 of SPGL008 （Intravenous administration）dose level 8 of SPGL008 （Intravenous administration）

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and/or females, 18-75 years old;
  • Histologically and/or cytologically documented advanced or metastatic malignant Tumors;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
  • Expected survival \>=3 months;
  • Signed informed consent form.

You may not qualify if:

  • Known uncontrolled or symptomatic central nervous system metastatic disease;
  • Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade \>1 (National Cancer Institute Common terminology Criteria \[NCI-CTCAE\] v.5.0);
  • Inadequate organ or bone marrow function;
  • Pregnant or breast-feeding woman;
  • Known allergies, hypersensitivity, or intolerance to SPGL008.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

RECRUITING

Central Study Contacts

yongsheng Li

CONTACT

17784310187lys@cqu.edu.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2025

First Posted

June 26, 2025

Study Start

July 30, 2025

Primary Completion (Estimated)

September 22, 2026

Study Completion (Estimated)

June 8, 2027

Last Updated

February 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)