A Phase I Study of IBI325 in Patients With Advanced Solid Tumor

Shandong First Medical University

Status and phase: Unknown; Phase 1

Conditions: Solid Tumor

Treatments: Drug: IBI325+Sintilimab

Study type: Interventional

Funder types: Other

Identifiers

NCT05246995

CIBI325Y001

Details and patient eligibility

About

The primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (RP2D) of IBI325 combined with Sintilimab in patients with advanced solid tumors

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion

1. Histologically confirmed, locally advanced unresectable or metastatic tumors.

2. At least one measurable lesion per RECIST 1.1

3. Male or female subject at least 18 years old and no more than 75 years old.

4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status 0 or 1.

5. Must have adequate organ function

6. Be able to provide archived or fresh tumor tissues Exclusion

7. Any anti-tumor treatment with 4 weeks, except anti-CD73 monoclonal antibody. 2. Subjects participating in another interventional clinical study, except for during the survival follow-up phase of the studies.

8. Unstable central nervous system netastases 4. Known active autoimmune disease or inflammatory disease 5. Known active infectious disease 6. Other uncontrolled systematic disease that may increase the risk of participating the study

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

IBI325 and Sintilimab combination does-escalation

Experimental group

Treatment:

Drug: IBI325+Sintilimab