Study of ZG0895.HCl in Patients With Advanced Solid Tumors

NCT05877664 | Recruiting Phase 1

• 1 other identifier: ZG0895-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to assess the tolerability and safety of ZG0895.HCl, and to assess the maximum tolerated dose (MTD)/ recommended phase 2 dose (RP2D) of ZG0895.HCl.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (4)

• The incidence of dose-limiting toxicity (DLT)

  DLT is defined as any of the following adverse events (AE) occurring from the first dose of Day 1 to Day 21, unless the investigator deems that the AE is clearly related to the disease progress or definitely due to an external cause. Delayed DLTs are adverse events that meet the criteria of DLTs that occur after Cycle 1. All AEs will be graded according to the US National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0), except for cytokine release syndrome (CRS)

  Up to Day 21

• The maximum tolerated dose (MTD) of ZG0895.HCl

  During the dose-escalation stage, if there is a first occurrence that ≥ 2 participants in a dose group experience DLT, then the dose level will be considered to be an intolerable dose, and the previous lower dose will be considered to be the MTD. The MTD group should have at least 6 evaluable participants.

  Up to Day 21

• Number of Participants Experiencing Adverse Events (AEs)

  Up to 3 Years

• Number of Participants Experiencing Serious Adverse Events (SAEs)

  Up to 3 Years

Secondary Outcomes (1)

• Overall Response Rate (ORR) as assessed by the investigator

  Up to 3 Years

Study Arms (1)

Part1：Dose Escalation

EXPERIMENTAL

During the dose-escalation stage, an accelerated titration design (ATD) will be utilized for the first three lower dose groups (0.06, 0.12 and 0.18 mg/m\^2). The conventional "3+3" dose escalation method will be used for the subsequent dose groups. The entire duration of 21 days after the first dose of ZG0895.HCl is defined as the dose-limiting toxicity (DLT) observation period.

Drug: ZG0895 Hydrochloride for Injection

Interventions

ZG0895 Hydrochloride for Injection DRUG

The dose escalation of ZG0895.HCl is set as 0.06, 0.12, 0.18, 0.37, 0.75, 1.50, 2.25, 3.00, and 3.75 mg/m\^2 groups, subcutaneous (SC) injection once a week (QW)

Also known as: ZG0895.HCl

Part1：Dose Escalation

Eligibility Criteria

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

You may qualify if:

• Fully understand the study and voluntarily sign the informed consent form(ICF).
• Age ≥ 18 and ≤ 75 years old at the time of signing the ICF, either male or female;
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Life expectancy ≥ 3 months.
• All adverse events from prior treatment have either returned to baseline or CTCAE 5.0 ≤ Grade 1(except for AEs not constituting a safety risk in the opinions of the investigators, e.g. alopecia, hypothyroidism which can be treated with a hormone replacement, etc).
• Both male and female participants (unless postmenopausal, surgical sterilization) and partners must agree to use a reliable form of contraception during the study treatment period and for at least 6 months after the last dose of the study drug.
• For lesions that have received radiation therapy, only after the progression of the lesions, they can be considered measurable lesions.
• Part 1:
• Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1).
• Participants with histologically or cytologically confirmed diagnosis of advanced solid tumors, in whom available standard treatments failed or were intolerable.

You may not qualify if:

• Participants receiving any of the following treatments:
• Previously treated with systemic TLR7/8 immunomodulators.
• Any other investigational product treatment within 4 weeks before the first dosing.
• Chemotherapy, biotherapy, endocrine therapy (except for hormone replacement), and biological targeted medicines within 4 weeks before the first dosing. Local palliative radiotherapy, traditional Chinese medicine with anti-tumor effect, and small molecule targeted therapy within 2 weeks (or 5 half-lives, whichever is longer) before the first dosing.
• Major surgery within 4 weeks before the first dosing for any reason (excluding puncture biopsy), or need to undergo elective surgery during the trial.
• Potent CYP3A4/5 inducer or inhibitor within 2 weeks prior to administration of the first dose of the study drug.
• Systemic immunosuppressive drugs within 2 weeks prior to administration of the first dose of the study drug, including systemic corticosteroids (\>10 mg/day prednisone or equivalent).
• Other immunomodulators within 2 weeks prior to administration of the first dose of the study drug, including but not limited to thymosin, interleukin-2 and interferon.
• Had CTCAE Grade ≥3 immune-related adverse events (irAE) after receiving immunotherapy.
• The main organ function meets any of the following criteria within 7 days prior to the first dosing. （Note: blood transfusion, EPO, G-CSF, albumin infusion and renal replacement therapy are not allowed within 14 days prior to treatment.)
• Hematological function: ANC \< 1.5×10\^9/L, PLT \< 75×10\^9/L, Hemoglobin (Hb) \< 100 g/L.
• Hepatic function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 3×ULN; ALT and AST ≥ 5×ULN for participants with liver metastases; Total bilirubin (TBIL) ≥ 1.5×ULN; albumin \< 30 g/L.
• Creatinine clearance\< 75 mL/min.
• INR \> 1.5 or APTT \> 1.5×ULN.
• The urine protein presents positive and the quantitative result of 24-h urine protein ≥ 1 g.

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (1)

Zhejiang Cancer Hospital

Zhejiang, Hangzhou, 310022, China

RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Jason Wu

  Suzhou Zelgen Biopharmaceuticals Co.,Ltd

  STUDY CHAIR

Central Study Contacts

Wenhao Cai

CONTACT

+8615918725852; caiwh@zelgen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: May 26, 2023
• Study Start: August 8, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 6, 2024

Record last verified: 2024-03

Locations

CN (1)