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

NCT06390774 | Recruiting Phase 1

• 1 other identifier: SSGJ-705-CA-Ⅰ-01
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced, Recurrent or Metastatic Malignancies

Keywords

advanced malignancies

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• ORR

  up to 1 year

• PFS

  up to 1 year

• Cmax

  up to 1 year

• T1/2

  up to 1 year

Study Arms (4)

Part 1

EXPERIMENTAL

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

Part 2

EXPERIMENTAL

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

Part 3

EXPERIMENTAL

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

Part 4

EXPERIMENTAL

Indication extension will be carried out at the selected level，including 3 dosage levels.

Drug: SSGJ-705

Interventions

SSGJ-705 DRUG

anti-PD-1 and anti-HER2 bispecific antibody

Part 1; Part 2; Part 3; Part 4

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Affiliated Cancer Hospital of Shandong First Medical University

Jinan, Shandong, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Neoplasms

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jinming Yu, MD,Ph.D

CONTACT

+86-13806406293; sdyujinming@126.com

Yuping Sun, MD,Ph.D

CONTACT

+86-13370582181; 13370582181@163.com

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: April 8, 2024
• First Posted: April 30, 2024
• Study Start: May 30, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)