A Study of Dose Escalation of IBI321 in Patients With Advanced Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-21

Study Completion Date

2023-02-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This first-in-human open-label, multicenter, dose-escalation and expansion study is designed to evaluate the safety, tolerability, and primary efficacy of IBI321 in participants with locally advanced, recurrent, or metastatic incurable tumors for whom standard therapy does not exist, has proven to be ineffective or intolerable.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of the Safety and Tolerability of IBI321 in Patients With Advanced Solid Tumors

NCT04911881

Advanced Solid Tumors

COMPLETED PHASE1

Study of IBI3005 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors

NCT06418061

Unresectable Locally Advanced or Metastatic Solid Tumors

RECRUITING PHASE1

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

NCT04085185

Advanced Malignancies

UNKNOWN PHASE1

A Clinical Trial to Evaluate Effect of IBB0979 in Patients With Advanced Malignant Tumors

NCT05991583

Advanced Malignant Tumors

RECRUITING PHASE1/PHASE2

IBI308 in Subjects With Advanced/Metastatic Solid Malignancies

NCT03568539

Advanced/Metastatic Solid Malignancies

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced Solid Tumors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Phase Ia Dose-Escalation Stage: IBI321

Group Type EXPERIMENTAL

IBI321

Intervention Type DRUG

Several dose levels will be evaluated for IBI321 administered as a single agent. IBI321 will be given via IV infusion on Day 1 of each cycle until disease progression or loss of clinical benefit.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

IBI321

Several dose levels will be evaluated for IBI321 administered as a single agent. IBI321 will be given via IV infusion on Day 1 of each cycle until disease progression or loss of clinical benefit.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Subjects able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures.
2. Patients with advanced solid tumors who had failed standard treatment.
3. Male or female subjects ≥18 years and ≤75 years.
4. At least one measurable lesion per RECIST version 1.1
5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1
6. Life expectancy of ≥ 12 weeks.
7. Adequate hematologic and end organ function

Exclusion Criteria

1. Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, targeted therapy, or immunotherapy.
2. Failure to recover from adverse events from the most recent anti-tumor
3. Acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
4. Subjects with CNS metastasis unless they are asymptomatic or adequately treated with radiotherapy and/or surgery and subjects are neurologically stable with minimal residual symptoms/signs.
6. Pregnancy, lactation, breastfeeding.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No