IBI397 or Combination Therapies in Patients With Advanced Malignancies

Innovent Biologics

Status and phase: Withdrawn; Phase 1

Conditions: Advanced Malignancies

Treatments: Drug: IBI397+Sintilimab; Drug: IBI397+Rituximab; Drug: IBI397

Study type: Interventional

Funder types: Industry

Identifiers

NCT05245916

CIBI397A101

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have failed the standard treatment for locally advanced, recurrent or metastatic solid tumor or have failed at least the second line standard treatment (including autologous stem cell transplantation) or have failed the first line standard treatment and are not eligible for autologous stem cell transplantation
• Willing to and able to provide written informed consent for the trial and able to comply with protocol-specified visits and related procedures
• ≥ 18 and ≤ 75 years of age on the day of signing the informed consent
• Have a performance scale of 0 or 1 on the Eastern Cooperative Oncology Group Performance Status (ECOG PS)
• Subjects with solid tumor: Have at least one measurable or assessable lesion as defined by RECIST v1.1; Subjects with lymphoma: Have at least one measurable or assessable lesion as defined by Lugano2014 criteria

Exclusion criteria

• Has been previously exposed to any CD47 antibody, SIRPα antibody, or CD47/SIRPα recombinant protein or other inhibitors that target the same pathway
• Is currently participating in another interventional study, except for observational (non-interventional) study or in the survival follow-up phase of an interventional study
• Requires long-term systemic hormone or any other immunosuppressive drug therapy, excluding inhaled hormone therapy
• Has acute or chronic active hepatitis B (defined as hepatitis B surface antigen [HBsAg] and/or hepatitis B core antibody positive [HBcAb] and hepatitis B virus [HBV] DNA copy number ≥ 1 × 104 copies/ml or ≥ 2000 IU/ml or higher than the lower limit of detection) or acute or chronic active hepatitis C virus (HCV) antibody positive; HCV antibody positive but RNA negative subjects are allowed
• Has a known history of severe allergic reaction to other monoclonal antibodies, or is allergic to any component of the IBI397 formulation.
• Is pregnant or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

IBI397 single-agent dose escalation

Experimental group

Treatment:

Drug: IBI397

IBI397+ Rituximab

Experimental group

Treatment:

Drug: IBI397+Rituximab

Drug: IBI397

IBI397 + Sintilimab

Experimental group

Treatment:

Drug: IBI397+Sintilimab

Drug: IBI397