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Status unknownNCT06533605Updated Aug 1, 2024

Phase I Clinical Study to Evaluate the Safety and Efficacy of SSGJ-706 Monotherapy for Patients With Advanced Solid Tumors

A Phase 1 interventional study of SSGJ-706 in Advanced Solid Tumors Patients, sponsored by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-08-01.

Sponsored by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. (part of 3SBio Inc.) · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2024), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This study includes two parts, different part has different administration frequencies of SSGJ-706.

Read the detailed description

This study is a study of SSGJ-706 monotherapy in advanced Solid Tumors. This study includes two parts, different part has different administration frequencies of SSGJ-706. Part A is QW and part B is Q3W. Each part will assess the efficacy and safety of the preset several dose levels of SSGJ-706 in advanced Solid Tumors.

02

Conditions studied

  • Advanced Solid Tumors Patients

Keywords

  • Solid Tumors
03

In context

Lead sponsor

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. is the lead sponsor of 58 studies on the registry; 21 are open to participants now.

First submitted after Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. became part of 3SBio Inc..

Browse Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. studies →All 3SBio Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Males and/or females over age 18
  2. Histologically and/or cytologically documented advanced or metastatic Solid Tumors .
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  4. Expected survival >=3 months.
  5. Signed informed consent form.

Exclusion criteria

Exclusion Criteria:

  1. Known uncontrolled or symptomatic central nervous system metastatic disease.
  2. 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).
  3. Inadequate organ or bone marrow function.
  4. Pregnant or breast-feeding woman.
  5. Known allergies, hypersensitivity, or intolerance to SSGJ-706 The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Arm 1

    dose level 1 of SSGJ-706

    Drug: SSGJ-706

  • Experimental
    Arm 2

    dose level 2 of SSGJ-706

    Drug: SSGJ-706

  • Experimental
    Arm 3

    dose level 3 of SSGJ-706

    Drug: SSGJ-706

  • Experimental
    Arm 4

    dose level 4 of SSGJ-706

    Drug: SSGJ-706

  • Experimental
    Arm 5

    dose level 5 of SSGJ-706

    Drug: SSGJ-706

  • Experimental
    Arm 6

    dose level 6 of SSGJ-706

    Drug: SSGJ-706

  • Experimental
    Arm 7

    dose level 1 of SSGJ-706

    Drug: SSGJ-706

  • Experimental
    Arm 8

    dose level 2 of SSGJ-706

    Drug: SSGJ-706

  • Experimental
    Arm 9

    dose level 3 of SSGJ-706

    Drug: SSGJ-706

  • Experimental
    Arm 10

    dose level 4 of SSGJ-706

    Drug: SSGJ-706

  • Experimental
    Arm 11

    dose level 5 of SSGJ-706

    Drug: SSGJ-706

  • Experimental
    Arm 12

    dose level 6 of SSGJ-706

    Drug: SSGJ-706

Interventions

  • DrugSSGJ-706

    Bispecific antibody

06

What researchers measure

Primary outcomes

  1. DLTs

    Dose limiting toxicity

    Time frame: 12 months

  2. MTD or MAD

    maximum tolerated dose or the maximum administered dose if MTD is not reached

    Time frame: 12 months

Secondary outcomes

  1. The blood concentration of SSGJ-706

    PK characteristics

    Time frame: 12 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Aug 2024; primary completion for Jul 2025, 11 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 29, 2024
First posted
Aug 1, 2024
StartEst.
Aug 2024
Primary completionEst.
Jul 30, 2025
CompletionEst.
Aug 31, 2025
Last update
Aug 1, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06533605
Lead sponsor
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Responsible party
Sponsor
First posted
Aug 1, 2024
Start date
Aug 2024 (estimated)
Primary completion
Jul 30, 2025 (estimated)
Completion
Aug 31, 2025 (estimated)
Last update
Aug 1, 2024

Study contacts

Hao Chen, MD, Ph.D
Contact
chenhao3996913@163.com
15009467790

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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