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NCT Number: NCT05923008

A Clinical Study of IBI130 for Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors

This is a phase 1/2 multicenter, open-label, first-in-human study of IBI130. It includes a phase 1 dose escalation and expansion section to identify MTD/RP2D of IBI130, plan to enroll 20~182 subjects,and a phase 2 to explore efficacy, safety and tolerability of IBI130 at RP2D in specified types of solid tumor.Approximately 150 evaluable subjects will be enrolled for phase 2.

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Sunshine Coast University

Birtinya, Queensland, 4575, Australia

Location status: Recruiting

Location contact

Michelle Morris

CONTACT

[email protected]

07 53906057

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;
  • Male or female subjects ≥ 18 years old;
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
  • Anticipated life expectancy of ≥ 12 weeks;
  • Adequate bone marrow and organ function

Exclusion criteria

  • Enrolled in any other interventional clinical research except unless only involved in an observational study (non-interventional) or in the follow-up phase of an interventional study;
  • Received previous anti-tumor therapy within 4 weeks or 5 half-lives of the anti-tumor regimens before the first administration of study drug, whichever is shorter;
  • Plan to receive other antitumor therapy during the study excluding palliative radiotherapy for the purpose of symptom (like pain) relief that must also do not have impact on tumor assessment throughout the study;
  • Received live vaccines within 4 weeks prior to first administration of the study drug or plan on receiving any live vaccine during the study;

Treatment and study plan

IBI130

Drug

Subjects will receive IBI130 until unacceptable toxicity, disease progression, withdrawal of consent, occurrence of other reasons for discontinuing study therapy, or for a maximum of 24 months of treatment, whichever occurs first.

Primary outcomes

  1. Adverse events (AEs)

    Time frame: Up to 30 days post last dose

    Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0

Secondary outcomes

  1. objective response rate (ORR)

    Time frame: Time from first dose to best response to treatment, assessed up to 3 years

    ORR is the percentage of complete response(CR) plus partial response assessed(PR) per RECIST v1.1 criteria

  2. duration of response(DoR)

    Time frame: Duration of response from the first documentation of objective response (confirmed CR or PR) to the first documented disease progression, assessed up to 3 years

    For subjects with CR or PR,duration of response(DoR) is the time from the first documented CR or PR to disease progression assessed per RESICT v1.1 criteria or death

  3. overall survival (OS)

    Time frame: Time from first dose to death, assessed up to 3 years

    Time from the date of the first dose to death of the subject due to any cause

Study contacts

Contact information is provided by the study sponsor or research team.

Serena Dong

CONTACT

[email protected]

0512 69566088

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

A Phase 1/2, Multicenter, Open-label Study of IBI130 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Jun 28, 2023
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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