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

A Phase I Clinical 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.

Study Overview

• Status: Recruiting
• Conditions: Locally Advanced, Recurrent or Metastatic Malignancies
• Intervention / Treatment: Drug: SSGJ-705

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 Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jinming Yu, MD,Ph.D; Phone Number: +86-13806406293; Email: sdyujinming@126.com
• Study Contact Backup: Name: Yuping Sun, MD,Ph.D; Phone Number: +86-13370582181; Email: 13370582181@163.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China
      • Recruiting
      • Affiliated Cancer Hospital of Shandong First Medical University
      • Contact: Zhaowei Li; Phone Number: 0531-67626929; Email: sdzlllh803@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1; 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.	Drug: SSGJ-705; anti-PD-1 and anti-HER2 bispecific antibody
Experimental: Part 2; 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.	Drug: SSGJ-705; anti-PD-1 and anti-HER2 bispecific antibody
Experimental: Part 3; 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.	Drug: SSGJ-705; anti-PD-1 and anti-HER2 bispecific antibody
Experimental: Part 4; Indication extension will be carried out at the selected level，including 3 dosage levels.	Drug: SSGJ-705; anti-PD-1 and anti-HER2 bispecific antibody

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	Objective response rate	up to 1 year
PFS	Progression-free Survival	up to 1 year
Cmax	Maximum Plasma Concentration	up to 1 year
T1/2	Half-life	up to 1 year

Collaborators and Investigators

• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: April 8, 2024
• First Submitted That Met QC Criteria: April 24, 2024
• First Posted (Actual): April 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: advanced malignancies
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: SSGJ-705-CA-Ⅰ-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No