Study of ZGGS18 in Combination With ZG005 in Patients With Advanced Solid Tumors

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSuzhou Zelgen Biopharmaceuticals Co.,Ltd

About this trial

This trial is designed to assess the tolerability, safety, pharmacokinetic profile, and preliminary efficacy of the combination of ZGGS18 and ZG005 in patients with advanced solid tumors, including advanced cervical cancer, hepatocellular carcinoma, neuroendocrine cancer, and lung cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Fully understand this study and voluntarily sign the ICF.

Age 18-75 years, no gender restriction.

Patients with advanced solid tumors who have failed standard treatment or are intolerant to standard treatment, as confirmed by histopathology or cytology.

Disqualifiers

Medical history, CT scan, or MRI indicates the presence of CNS metastases.

Other malignancies within 5 years.

Any other reason deeming the participant unsuitable for the study, as judged by the investigator.

Trial design

Design model

Sequential

Treatments tested in this trial

  • ZGGS18 for Injection

    Biological/Vaccine

    Intravenous infusion

  • ZG005 for Injection

    Biological/Vaccine

    Intravenous infusion

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Phase 1 Dose EscalationExperimental treatment 2 interventions
Group B: Phase 2 Dose ExpansionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Dose limited toxicity(DLT)

Incidence and severity of DLT events

Time frame
up to 21 days
2

Adverse Event (AE)

Abnormal changes in clinical symptoms, vital signs, physical examination, laboratory tests, electrocardiograph and other examinations.

Time frame
Up to 2 years
3

Maximum tolerated dose(MTD)

Time frame
Up to 1 years
4

Recommended phase II dose(RP2D)

Time frame
Up to 1 years

Secondary outcomes

1

Objective response rate (ORR)

Objective Response Rate as Assessed by Investigator according to RECIST v1.1

Time frame
Up to 2 years
2

Immunogenicity

Incidence of antidrug antibodies (ADA)

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

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