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Status unknownNCT04916119Updated Sep 16, 2022

Study of IBI323 in Patients With Advanced Malignancies

A Phase 1 interventional study of IBI323 in Advanced Malignancies, sponsored by Innovent Biologics (Suzhou) Co. Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-09-16.

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

The sponsor has not verified this record recently (last verified Sep 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
322
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
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Study summary

The purpose of this study is to evaluate safety, tolerability and efficacy of IBI323(anti-LAG-3/PD-L1) or in combination with chemotherapy in participants with advanced malignancies. Another purpose is to determine the pharmacokinetics,pharmacodynamics and immunogenicity of IBI323

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Conditions studied

  • Advanced Malignancies

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 322 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd. is the lead sponsor of 192 studies on the registry; 44 are open to participants now.

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

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

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Who can participate

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

Inclusion criteria

  1. Phase Ia Patients with locally advanced, recurrent or metastatic solid tumors who have failed standard treatment Phase Ib cohort A Patients with IO-refractory advanced NSCLC cohort B Patients with IO-naive advanced NSCLC who have failed standard treatment cohort C Patients with advanced NSCLC who have no prior treatment and PD-L1 TPS≥1% cohort D Patients with ES-SCLC or G3 neuroendocrine tumors who have failed standard treatment cohort E Patients with advanced MPM who have failed standard treatment cohort F Patients with advanced UC who have failed standard treatment cohort G Patients with advanced nccRCC who have failed standard treatment cohort H Patients with advanced HCC who have failed standard treatment cohort I Patients with advanced NPC who have failed standard treatment cohort J Patients with advanced CC or HNSCC who have failed standard treatment cohort K Patients with advanced GC or GEJC with HER2 negative who have no prior treatment cohort L Patients with advanced TNBC who have failed standard treatment
  2. Able to understand and willing to sign the ICF.
  3. 18 to 75 years old.
  4. Life expectancy at least 12 weeks.
  5. At least 1 measurable lesion per RECIST v1.1.
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  7. Adequate organ and bone marrow functionAdequate organ and bone marrow function.

Exclusion criteria

Exclusion Criteria:

  1. Prior treatment with any anti- LAG-3 antibody.
  2. Prior immunotherapy treatment for Stage Ia extension cohort ( immunotherapy untreated) and Stage Ib cohort B-L
  3. Any investigational drugs received within 4 weeks prior to the first study treatment.
  4. Receive the last dose of anti-tumor therapy within 4 weeks before the first dose of study therapy.
  5. Symptomatic CNS metastasis.
  6. History of autoimmune disease , present active autoimmune disease or inflammatory diseases
  7. Pregnant or nursing females.
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
322 participants (estimated)

Study arms

  • Experimental
    IBI323

    Phase Ia enrolls patients with advanced malignancies. Phase Ib cohort A enrolls patients with NSCLC(IO-refractory), cohort B NSCLC(IO-naive), cohort C NSCLC(PD-L1 TPS≥1%), cohort D ES-SCLC or neuroendocrine tumors, cohort E MPM, cohort F UC, cohort G nccRCC, cohort H HCC, cohort I NPC, cohort J CC or HNSCC, cohort K GC or GEJC with HER2 negative, cohort L TNBC

    Drug: IBI323

Interventions

  • DrugIBI323

    In phase Ia study, seven dose levels of IBI323 (0.03, 0.1, 0.3, 1, 3, 10 and 20mg/kg) will be evaluated. The DLT observation period is 28 days. IBI323 is administered by iv infusion day 1 of every 14 days. After dose escalation stage completed, two dose levels (10mg/kg and 20mg/kg) will be expanded to 20 patients each. In Phase Ib study, IBI323 is administered RP2D by iv infusion day 1 of every 14 days. IBI323 and chemotherapy will be administrated in cohort C and cohort K

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What researchers measure

Primary outcomes

  1. Incidence of Adverse Events (AEs)

    To evaluate the safety and tolerability of IBI323 \[Adverse events (AEs), treatment-related AE (TRAE), immune-related AEs (irAE), serious adverse event (SAE), dose-limiting toxicity (DLT) assessed by CTCAE v5.0\]

    Time frame: 24 months

Secondary outcomes

  1. Investigator Assessments of Overall Response Rate(ORR)

    RECIST v1.1 will be used to determine ORR by investigator

    Time frame: 24 months

  2. Disease Control Rate(DCR)

    RECIST v1.1 will be used to determine DCR by investigator

    Time frame: 24 months

  3. PFS (progression-free survival)

    RECIST v1.1 will be used to determine PFS by investigator

    Time frame: 24 months

  4. Anti-drug antibody (ADA)

    Time frame: 24 months

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Study locations

1 of 1 sites recruiting
  • Shang Hai Pulmonary Hospital
    Shanghai, Shanghai 200433, China
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04916119
Lead sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Responsible party
Sponsor
First posted
Jun 7, 2021
Start date
Jun 29, 2021
Primary completion
Jun 23, 2023 (estimated)
Completion
Dec 9, 2023 (estimated)
Last update
Sep 16, 2022

Study contacts

yu Wang
Contact
yu.wang01@innoventbio.com
0512-69566088

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 status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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