Participants will be treated with escalating doses of IBI110 to determine the MTD.

Participants will be enrolled in the expansion stage to better characterize the safety, tolerability, PK variability, and preliminary efficacy of IBI110 in different cancer types.

Participants will be treated with escalating doses of IBI110 in combination with a fixed dose of Sintilimab to determine the MTD.

Participants will be enrolled in the expansion stage to better characterize the safety, tolerability, PK variability, and preliminary efficacy of IBI110 in combination with Sintilimab in different cancer types.

Several dose levels will be evaluated for IBI110 administered as a single agent and in combination with Sintilimab. IBI110 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit. Those who discontinue treatment with single-agent IBI110 may receive combination treatment with IBI110 plus Sintilimab. Combination treatment may continue until disease progression or loss of clinical benefit.

IBI110

IBI110 will be given with RP2D. IBI110 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit.

IBI110: Several dose levels will be evaluated for IBI110 in combination with Sintilimab. IBI110 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit.

Sintilimab: Sintilimab will be given as 200 mg via IV infusion on Day 1 of each 21-day cycle in combination with IBI110. Combination treatment may continue until disease progression or loss of clinical benefit.

IBI110+ Sintilimab

IBI110: IBI110 in combination with Sintilimab will be given with RP2D. IBI110 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit.

Sintilimab: Sintilimab will be given as 200 mg via IV infusion on Day 1 of each 21-day cycle in combination with IBI110. Combination treatment may continue until disease progression or loss of clinical benefit.

Qian Qu, Bachelor

Caicun Zhou, M.D

Caicun Zhou

This is an open-label, dose escalation, Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of IBI110 in subjects with advanced malignancies.

A Study Evaluating the Safety, Tolerability, and Initial Efficacy of IBI110 in Subjects With Advanced Malignant Tumors

A Phase 1a, Open-label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Initial Efficacy of IBI110 in Subjects With Advanced Malignant Tumors

To evaluate the safety and tolerability of IBI110 alone or in combination with Sintilimab \[Adverse events (AEs), Serious Adverse Events (SAEs) \]

To evaluate the safety and tolerability of IBI110 alone or in combination with Sintilimab.

The area under the curve (AUC) of serum concentration of the drug after the administration.

Maximum concentration (Cmax) of the drug after administration

Immunogenicity: Number of Anti-Drug Antibodies (ADA) positive subjects will be counted and percentage of ADA positive subjects will be calculated to evaluate immunogenicity of IBI110.

Objective Response Rate (ORR) is the percentage of Complete Response (CR) plus partial response (PR) assessed by RECIST v1.1 criteria for solid tumors and Lugano2014 criteria for lymphoma.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study Evaluating the Safety, Tolerability, and Initial Efficacy of IBI110 in Subjects With Advanced Malignant Tumors	NCT04085185	Advanced Malign...	IBI110 IBI110 IBI110+ Sintili... IBI110+ Sintili...	18 Years - 75 Years	Innovent Biologics (Suzhou) Co. Ltd.
A Study Evaluating the Safety, Tolerability, and Initial Efficacy of IBI110 in Subjects With Advanced Malignant Tumors	NCT04085185	Advanced Malign...	IBI110 IBI110 IBI110+ Sintili... IBI110+ Sintili...	18 Years - 75 Years	Innovent Biologics (Suzhou) Co. Ltd.

Spots Global Cancer Trial Database for ibi110+ sintilimab