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NCT Number: NCT06390774

A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SSGJ-705 Monotherapy in Patients with Advanced Malignant Tumors

This study was an open-label phase I study to evaluate the safety, tolerability, PK profile and potential efficacy of SSGJ-705 as a single agent in patients with advanced malignancies.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Affiliated Cancer Hospital of Shandong First Medical University

Jinan, Shandong, China

Location status: Recruiting

Location contact

Zhaowei Li

CONTACT

[email protected]

0531-67626929

About this study

This study includes 4 Parts: Part 1 (dose escalation and dose extension for QW administration), Part 2 (dose escalation and dose extension for Q2W administration), Part 3 (dose escalation and dose extension for Q3W administration), and Part 4 (indication extension, such as HER2 expression, PD-L1 high expression, driver gene negative newly treated advanced NSCLC, or other tumors).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and/or females over age 18
  • Histologically and/or cytologically documented local advanced or recurrent or metastatic malignancies
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Expected survival >3 months.
  • Signed informed consent form.
  • Must have adequate organ function.

Exclusion criteria

  • Any remaining AEs > grade 1 from prior anti-tumor treatment as per CTCAE v5. 0, with exception of hair loss, fatigue, and grade 2 peripheral neurotoxicity.
  • Pregnant or nursing women or women/men who are ready to give birth
  • Symptomatic central nervous system metastasis.
  • Allergy to other antibody drugs or any excipients in the study drugs.
  • Severe dyspnea at rest due to complications of advanced malignant tumors, or needing supplemental oxygen therapy.
  • Participated in any clinical study of medical devices or drugs within 1 month prior to screening (excluding non-intervention clinical studies or follow-up period of intervention clinical studies) .

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Treatment and study plan

SSGJ-705

Drug

anti-PD-1 and anti-HER2 bispecific antibody

Primary outcomes

  1. DLTs

    Time frame: 14 days

    Dose limiting toxicity

  2. AE

    Time frame: up to 1 year

    Safety and tolerability assessed by incidence and severity of adverse events

  3. MTD or MAD

    Time frame: up to 1 year

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

  4. RP2D

    Time frame: up to 1 year

    the recommended phase II dose

Secondary outcomes

  1. ORR

    Time frame: up to 1 year

    Objective response rate

  2. PFS

    Time frame: up to 1 year

    Progression-free Survival

  3. Cmax

    Time frame: up to 1 year

    Maximum Plasma Concentration

  4. T1/2

    Time frame: up to 1 year

    Half-life

Study contacts

Contact information is provided by the study sponsor or research team.

Jinming Yu, MD,Ph.D

CONTACT

[email protected]

+86-13806406293

Yuping Sun, MD,Ph.D

CONTACT

[email protected]

+86-13370582181

Sponsors and collaborators

Lead sponsor

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Industry

Registry information

Official study title

A Phase I Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SSGJ-705 Monotherapy in Patients with Advanced Malignant Tumors

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Apr 30, 2024
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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