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CompletedNCT05043298Updated Oct 17, 2024

A Phase Ia/Ib Clinical Trial of IBI360 Monotherapy or in Combination With Sintilimab and (or) Chemotherapy in Advanced or Metastatic Solid Tumors

A Phase 1 interventional study of IBI 360 Injection and IBI 360 Injection Sintilimab in Advanced Solid Tumor, sponsored by Innovent Biologics (Suzhou) Co. Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-10-17.

Sponsored by Innovent Biologics (Suzhou) Co. Ltd. (part of Innovent Biologics, Inc.) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This is an open label Phase Ia/Ib trial to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of IBI360 monotherapy in Advanced or Metastatic Solid Tumors

Read the detailed description

Phase Ia is dose escalation and dose expansion study of IBI360 monotherapy and IBI360 in combination with sintilimab in advanced or metastatic Solid Tumors; Phase Ib is an multi-cohort trial of pancreatic carcinoma, HER2 negative gastric adenocarcinoma, advanced or metastatic solid tumors to evaluate safety and preliminary efSficacy of IBI360 in combination with sintilimab and (or) chemotherapy or IBI360 monotherapy.

02

Conditions studied

  • Advanced Solid Tumor

Keywords

  • Advanced Solid Tumor
03

In context

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd. is the lead sponsor of 197 studies on the registry; 46 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Browse Innovent Biologics (Suzhou) Co. Ltd. studies →All Innovent Biologics, Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Provide signed informed consent;
  2. Male or female aged at 18-75 (inclusive) years;
  3. Expected survival ≥12 weeks;
  4. ECOG PS score 0 or 1;
  5. Provide archival or fresh tissues for CLDN18.2 expression analysis;
  6. Adequate laboratory parameters;
  7. Suffer from advanced or metastatic malignant local solid tumors confirmed by histological diagnosis and meet the criteria of the enrolled group as follows:

Ia: The subjects for whom no standard treatment regimens are available or who is intolerable to standard treatments.

Ib: pancreatic carcinoma, HER2 negative gastric adenocarcinoma, advanced or metastatic solid tumors

Exclusion criteria

Exclusion Criteria:

  1. The subjects who received the treatment with CLDN18.2 monoclonal antibody or CLDN-18.2 CART;
  2. The subjects who received other anti-tumor medication within 4 weeks prior to the initial dose of the study drug;
  3. Any toxicity due to previous anti-tumor therapy that has not yet resolved to NCI CTCAE v5.0 grade 0 or 1 prior to the first dose of study treatment;
  4. The subjects with history of hypersensitivity to the study drug;
  5. The subjects were not recovery after surgery with history of gastrointestinal perforation or fistula within 6 months prior to the enrollment;
  6. The subjects with symptomatic central nervous system (CNS) metastasis or carcinomatous meningitis;
  7. The subjects with pyloric obstruction;
  8. The subjects with active or poorly controlled serious infections
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    IBI360

    Drug: IBI 360 Injection

  • Experimental
    IBI 360 + Sintilimab

    Drug: IBI 360 Injection Sintilimab

Interventions

  • DrugIBI 360 Injection

    IBI 360 dose level of escalation IV Q3W Day 1

  • DrugIBI 360 Injection Sintilimab

    IBI 360 dose level of escalation IV Q3W Day 1 Sintilimab 200mg IV Q3W Day 1

06

What researchers measure

Primary outcomes

  1. Safety and tolerance

    Participant safety is characterized by frequency and severity of adverse events(according to NCI CTCAE 5.0)

    Time frame: up to 90 days following last dose

  2. Recommended Phase 2 Dose (RP2D)

    A recommended phase 2 dose will be determined based on safety data including dose limiting toxicities, preliminary efficacy data, and PK data

    Time frame: up to 21 days following last dose level

Secondary outcomes

  1. Efficacy

    Tumor response will be determined by the revised Response Evaluation Criteria in Solid Tumors version 1.1 (RECISTv1.1).

    Time frame: Subjects were randomized 6 months and 1 year later

  2. Pharmacokinetics

    Area under plasma concentration vs time curve(AUC)

    Time frame: Up to 48 weeks following first dose

  3. Immunogenicity

    Incidence of anti-drug antibodies (ADA) will be measured

    Time frame: up to 90 days following last dose

  4. Pharmacokinetics

    Peak plasma concentration(Cmax)

    Time frame: Up to 48 weeks following first dose

  5. Pharmacokinetics

    Up to 48 weeks following first dose

    Time frame: Clearance（CL）

  6. Pharmacokinetics

    Apparent volumeof distribution（V）

    Time frame: Up to 48 weeks following first dose

  7. Pharmacokinetics

    Terminal Half Life（T1/2）

    Time frame: Up to 48 weeks following first dose

07

Study locations

1 site
  • Innovent Biologics (suzhou) Co. , Ltd.
    Suzhou, Jiangsu 215000, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05043298
Lead sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Responsible party
Sponsor
First posted
Sep 14, 2021
Start date
Oct 27, 2021
Primary completion
Aug 30, 2023
Completion
Aug 30, 2023
Last update
Oct 17, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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