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

NCT05923008 | Recruiting Phase 1

• 1 other identifier: CIBI130A101
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Adverse events (AEs)

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

  Up to 30 days post last dose

Secondary Outcomes (3)

• objective response rate (ORR)

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

• duration of response(DoR)

  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

• overall survival (OS)

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

Study Arms (1)

IBI130

EXPERIMENTAL

IBI130

Drug: IBI130

Interventions

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.

IBI130

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Sunshine Coast University

Birtinya, Queensland, 4575, Australia

RECRUITING

Central Study Contacts

Serena Dong

CONTACT

0512 69566088; suhua.dong@innoventbio.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: June 19, 2023
• First Posted: June 28, 2023
• Study Start: November 14, 2023
• Primary Completion: November 30, 2024
• Study Completion (Estimated): October 31, 2026
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

AU (1)