IBI397 or Combination Therapies in Patients With Advanced Malignancies

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Study ID
NCT05245916
Phase
PHASE1
Status
Withdrawn

Conditions

  • Advanced Malignancies

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • IBI397 — DRUG
    IBI397 single-agent dose escalation： Subjects will receive IBI397 until disease progression, unacceptable toxicity, withdrawal of consent, occurrence of other conditions that require discontinuation of study treatment, or the treatment duration has reached 24 months, whichever occurs first
  • IBI397+Sintilimab — DRUG
    IBI397 in combination with sintilimab： Subjects will receive IBI397 combination therapy with sintilimab until disease progression, unacceptable toxicity, withdrawal of consent, occurrence of other conditions that require discontinuation of study treatment, or the treatment duration has reached 24 months, whichever occurs first
  • IBI397+Rituximab — DRUG
    IBI397 in combination with rituximab： Subjects will receive IBI397 combination therapy with rituximab until disease progression, unacceptable toxicity, withdrawal of consent, occurrence of other conditions that require discontinuation of study treatment, or the treatment duration has reached 24 months, whichever occurs first

Study Details

The primary objective of this phase Ia/Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of IBI397 or its Combination Therapies in Patients with Advanced Malignancies

Key Dates

Start date
Apr 14, 2022
Status verified
Aug 2023
Primary completion
Aug 24, 2023
Completion
Aug 24, 2023

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: IBI397 single-agent dose escalation
  • Experimental: IBI397+ Rituximab
  • Experimental: IBI397 + Sintilimab

Primary Outcome Measure

Number of patients with treatment related AEs [ Time Frame: Up to 90 days post last dose ]

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