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RECRUITINGPHASE1

A Study of IBI363 in Subjects With Advanced Malignancies

Phase Ib Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of IBI363 Combination Therapy in Subjects With Advanced Malignancies

NCT06468098•Innovent Biologics (Suzhou) Co. Ltd.

View on ClinicalTrials.gov

Summary

This is an open-label, multicenter Phase Ib study to evaluate the safety, tolerability, and efficacy of IBI363 in advanced malignancies patients

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Sign written informed consent and be able to comply with the program's visit schedule and related procedures.
•2. Male or female subjects, age 18\~75 years.
•3. Histologically or cytologically confirmed advanced malignancy.
•4. Subjects who have progressed on standard therapy, who are unsuitable for standard therapy, who do not have standard therapy, or who have refused standard therapy. For particular cohort, subjects who have not received prior systemic therapy for advanced disease.
•5. At least one measurable lesion (target lesion) per RECIST v1.1.
•6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
•7. Life expectancy of 3 months or more.
•8. Female subjects of childbearing age or male subjects whose partners are female subjects of childbearing age agree to strictly adopt effective contraceptive measures throughout the entire treatment period and 6 months after the treatment period.

Exclusion Criteria

•1. Women who are pregnant or lactating, or intending to become pregnant before, during, or within 6 months after the last dose of study drug.
•2. Active or untreated CNS metastases confirmed by imaging evaluation during screening or previous imaging evaluation. Patients with asymptomatic brain metastases may participate in this study.
•3. History of active thrombosis or deep vein thrombosis or pulmonary embolism within 4 weeks prior to the first dose of study drug.
•4. Clinically significant cardiovascular or cerebrovascular disease.
•5. Interstitial pneumonia, pulmonary fibrosis, pneumoconiosis, drug-associated pneumonia, and radiation pneumonitis requiring steroid hormone or other therapy, as well as history of severe abnormal lung function or other forms of restrictive lung disease.
•6. History of allergies, asthma, atopic dermatitis.
•7. Concomitant pleural or pericardial effusion requiring repeated drainage or with significant symptoms.
•8. Active autoimmune disease requiring systemic therapy within 2 years prior to first dose.
•9. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
•10. Subjects with known or suspected hypersensitivity to the study drug and any excipients.
+13 more criteria

Locations (1)

Shanghai Chest Hospita

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

June 15, 2024

Primary Completion Date

June 30, 2025

Completion Date

December 31, 2026

Last Updated

July 18, 2024

Enrollment

556

ESTIMATED participants

Conditions

Advanced Malignancies

Interventions

IBI363 + chemotherapy

DRUG

IBI363 + Investigator's Choice SOC

DRUG

Contacts

binbin Min

CONTACT

0512-69566088 bingo.min@innoventbio.com

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RECRUITINGPHASE1

Study to Assess Safety, Tolerability and Activity of DSB2455 in Participants With Advanced Malignancies

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 18, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of IBI363 in Subjects With Advanced Malignancies

Inclusion Criteria

Exclusion Criteria

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