Health TrialsbyHealthPanel

SSGJ-705 Plus SSGJ-612 ± Chemotherapy in Advanced HER2-Expressing Solid Tumors

ConditionLocally Advanced (Unresectable) or Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShenyang Sunshine Pharmaceutical Co., LTD.

About this trial

This study was an open-label phase Ⅱ study to evaluate the safety and efficacy of SSGJ-705 Plus SSGJ-612 ± Chemotherapy in patients with advanced HER2-Expressing Solid Tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males and/or females over age 18

Histologically and/or cytologically documented local advanced or metastatic Colorectal adenocarcinoma (CRC), Urothelial Cancer (UC), Breast Cancer (BC), Biliary Tract Carcinoma(BTC), Gastric/Gastroesophageal Junction Cancer （G/GEJC) , etc.

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Expected survival >3 months.

Disqualifiers

Any remaining adverse events (AEs) > grade 1 from prior anti-tumor treatment as per Common Terminology Criteria for Adverse Events（CTCAE） v6. 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.

Trial design

Design model

Single group

Treatments tested in this trial

  • SSGJ-705

    Drug

    anti-PD-1 and anti-HER2 bispecifc antibody

  • SSGJ-612

    Drug

    anti-HER2 antibody

  • SSGJ-705 combined with chemotherapy

    Drug

    SSGJ-705 combined with chemotherapy

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Part 1Experimental treatment 2 interventions
Group B: Part 2Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

The primary efficacy end point

Time frame
12 months
2

Incidence of Treatment-Emergent Adverse Events

The primary safety end point

Time frame
12 months
3

Severity of Treatment-Emergent Adverse Events

The primary safety end point

Time frame
12 months

Secondary outcomes

1

Progression-Free-Survival (PFS)

The secondary efficacy end point

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shenyang Sunshine Pharmaceutical Co., LTD.

Lead sponsor

Source ClinicalTrials.gov
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