Study of ZG005 in Combination With Gecacitinib and Chemotherapy for Participants With Advanced Solid Tumors

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

About this trial

This is a multicenter, open-label phase I/II study for participants with advanced solid tumors who have failed prior immune checkpoint inhibitor therapies.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Fully understand the study and voluntarily sign the informed consent form.

Male or female 18-75 years of age.

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.

PART 1: Histologically confirmed unresectable locally advanced, recurrent, or metastatic solid tumors.PART 2 Cohort A: Histologically confirmed unresectable locally advanced, recurrent, or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma. Cohort B: Histologically confirmed unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma. Cohort C: Histologically confirmed unresectable locally advanced, recurrent, or metastatic other solid tumors.

Disqualifiers

participants were deemed unsuitable for participating in the study by the investigator for any reasons.

Trial design

Design model

Sequential

Treatments tested in this trial

  • ZG005

    Drug

    ZG005 20mg/kg; once every 3 weeks;IV infusion

  • Gecacitinib

    Drug

    Gecacitinib for dose escalations are set as 100mg Bid po. Gecacitinib for dose expansion will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose-escalation stage.

Treatment groups

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

Trial outcomes

Primary outcomes

1

Dose Limiting Toxicity (DLT)

Time frame
During the first 28 days
2

Objective Response Rate (ORR)

Time frame
Up to 2 years
3

Adverse events (AEs)

Time frame
Up to 2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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