A Clinical Study to Evaluate the Safety of VIB305 in Patients With Advanced Solid Tumors

NCT07222969 | Recruiting Phase 1 FDA Drug

• 1 other identifier: VIB305-001
• Study Type: interventional
• Target: 146
• Locations: 2 countries
• Sites: 2

Brief Summary

This clinical trial is an open-label, single-arm, non-randomized, dose-escalation and dose-expansion study targeting subjects with unresectable, advanced, malignant solid tumors who have failed or are unsuitable for standard treatments or refused the existing treatments. This study is divided into a dose-escalation phase (Phase I) and a dose-expansion phase (Phase II). Phase I (dose escalation) is designed to preliminarily evaluate the safety and tolerability of VIB305 in advanced solid tumors, to determine the nature and incidence of dose-limiting toxicities (DLTs), and thereby to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). Based on the findings from the Phase I portion for evaluation in the Phase II portion. Phase II (dose expansion) will enroll additional cohorts to further assess the safety and tolerability, PK profile, preliminary antitumor activity and immunogenicity of VIB305 in specific tumor types (selected based on all available data).

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• MTD and/or RP2D based on the incidence and nature of DLTs

  Incidence of dose-limiting toxicities (DLTs)

  At the end of Cycle 1 (each cycle is 21 days)

• Adverse events（AE）

  Include SAEs, TEAEs

  From signed ICF to 30 days after the last drug administration

Secondary Outcomes (9)

• The immunogenicity of VIB305

  Pre-dose of Cycle 1, Cycle 1 Day 15, pre-dose of Cycle 2, Cycle 2 Day 15, pre-dose of Cycle 3, Cycle 4 and following cycle(each cycle is 21 days) , 30 days after the last administration, 90 days after the last administration

• Objective response rate (ORR)

  From signed ICF to 30 days after the last drug administration

• Duration of response (DOR)

  From signed ICF to 30 days after the last drug administration

• Disease control rate(DCR)

  From signed ICF to 30 days after the last drug administration

• Progression-free survival (PFS)

  From signed ICF to 30 days after the last drug administration

Study Arms (6)

VIB305 for Injection in Cohort 1

EXPERIMENTAL

VIB305 for Injection does in Cohort 1 according to protocol

Drug: VIB305 for Injection

VIB305 for Injection in Cohort 2

EXPERIMENTAL

VIB305 for Injection does in Cohort 2 according to protocol

Drug: VIB305 for Injection

VIB305 for Injection in Cohort 3

EXPERIMENTAL

VIB305 for Injection does in Cohort 3 according to protocol

Drug: VIB305 for Injection

VIB305 for Injection in Cohort 4

EXPERIMENTAL

VIB305 for Injection does in Cohort 4 according to protocol

Drug: VIB305 for Injection

VIB305 for Injection in Cohort 5

EXPERIMENTAL

VIB305 for Injection does in Cohort 5 according to protocol

Drug: VIB305 for Injection

VIB305 for Injection in Cohort 6

EXPERIMENTAL

VIB305 for Injection does in Cohort 6 according to protocol

Drug: VIB305 for Injection

Interventions

VIB305 for Injection DRUG

Intravenous infusion: once every week, each treatment cycle is 3 weeks.

VIB305 for Injection in Cohort 1; VIB305 for Injection in Cohort 2; VIB305 for Injection in Cohort 3; VIB305 for Injection in Cohort 4; VIB305 for Injection in Cohort 5; VIB305 for Injection in Cohort 6

Eligibility Criteria

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

You may qualify if:

• Aged ≥18 years, male or female.
• Subjects with histologically or cytologically confirmed advanced solid tumors that are unresectable, who are refractory to or intolerant of or refuse all existing therapy(ies) known to provide clinical benefit for their condition.
• At least one measurable lesion as assessed by RECIST 1.1.
• ECOG performance status score of 0-1.
• Estimated survival time of more than 3 months.
• Adequate organ function.
• Females of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to first administration of the investigational drug. Females of childbearing potential must agree to abstain or use highly effective contraception from the time of signing informed consent form until 6 months after their last dose of the investigational drug.
• Male subjects of reproductive capacity must agree to use effective contraception from the time of signing informed consent form until 6 months after their last dose of the investigational drug.
• Subjects must be fully informed about this study before participation and must voluntarily sign a written informed consent form.

You may not qualify if:

• Receipt of chemotherapy, biotherapy, endocrine therapy, immunotherapy, or other systemic anti-tumor therapy within 4 weeks prior to first dose of investigational drug.
• Receipt of radiotherapy within 4 weeks prior to initiation of study treatment, or history of radiation pneumonitis.
• Receipt of any other investigational drugs not yet marketed within 4 weeks prior to first dose of investigational drug.
• Receipt of major organ surgery or occurrence of significant trauma, or requirement for elective surgery during the study, within 4 weeks prior to first dose of investigational drug.
• Use of systemic glucocorticoids or other immunosuppressive agents within 14 days prior to the first dose of investigational drug or anticipated need during the study.
• Use of immunomodulatory agents, including but not limited to thymosin, interleukin-2, interferons, etc., within 14 days prior to first administration of investigational drug.
• Receipt of live vaccine or attenuated live vaccine within 4 weeks prior to first use of investigational drug. Inactivated vaccines are permitted.
• History of prior allogeneic bone marrow transplantation or organ transplantation.
• Adverse reactions from prior anti-tumor therapy have not recovered to ≤ Grade 1 based on CTCAE v5.0.
• Subjects with central nervous system (CNS) metastasis.
• Severe chronic or active infections requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days prior to first dose.
• Known history of human immunodeficiency virus (HIV) positivity or history of acquired immunodeficiency syndrome (AIDS).
• Subjects with active hepatitis B virus (HBV) infection.
• History of other malignancies within the past 5 years.
• History of severe cardiovascular or cerebrovascular disease.

Sponsors & Collaborators

• Vibrant Sciences Limited: lead

Study Sites (2)

Sunshine Coast University Private Hospital

Sunshine Coast, Australia

RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Li Zhang

  Sun Yat-Sen University Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenting Li

CONTACT

+86-020-82513080; liwenting@vibrantx.io

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2025
• First Posted: October 30, 2025
• Study Start: January 12, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

AU (1); CN (1)