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

Phase 1

Recruiting

• Conditions: Locally Advanced, Recurrent or Metastatic Malignancies
• Interventions: Drug: SSGJ-705

• Registration Number: NCT06390774
• Lead Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study First Submitted: 2024-04-08
• Study First Submitted QC: 2024-04-24
• Study First Posted: 2024-04-30
• Study Start: 2024-05-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-18
• Primary Completion: 2026-12
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

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

Exclusion Criteria

1. 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.
2. Pregnant or nursing women or women/men who are ready to give birth
3. Symptomatic central nervous system metastasis.
4. Allergy to other antibody drugs or any excipients in the study drugs.
5. Severe dyspnea at rest due to complications of advanced malignant tumors, or needing supplemental oxygen therapy.
6. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Part 1	SSGJ-705	Dose escalation will be conducted using a traditional 3+3 design. Dose Escalation includes 6 levels, QW IV. Dose extension will be carried out at the selected level.
Part 2	SSGJ-705	Dose escalation will be conducted using a traditional 3+3 design. Dose Escalation includes 6 levels, Q2W IV. Dose extension will be carried out at the selected level.
Part 3	SSGJ-705	Dose escalation will be conducted using a traditional 3+3 design. Dose Escalation includes 6 levels, Q3W IV. Dose extension will be carried out at the selected level.
Part 4	SSGJ-705	Indication extension will be carried out at the selected level，including 3 dosage levels.

Primary Outcome Measures

Name	Time	Method
AE	up to 1 year	Safety and tolerability assessed by incidence and severity of adverse events
MTD or MAD	up to 1 year	maximum tolerated dose or the maximum administered dose if MTD is not reached
RP2D	up to 1 year	the recommended phase II dose
DLTs	14 days	Dose limiting toxicity

Secondary Outcome Measures

Name	Time	Method
PFS	up to 1 year	Progression-free Survival
Cmax	up to 1 year	Maximum Plasma Concentration
T1/2	up to 1 year	Half-life
ORR	up to 1 year	Objective response rate

Trial Locations

Locations (1)

Affiliated Cancer Hospital of Shandong First Medical University; 🇨🇳 Jinan, Shandong, China