A Study of IBI363 in Subjects with Advanced Solid Malignancies

Part of paid clinical trials in San Francisco, California.

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Study ID
NCT06281678
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IBI363 — DRUG
    IBI363 will be administered as an intravenous (IV) infusion every 2 weeks or every 3 weeks. Subjects will receive study medication until disease progression, toxicity intolerance, withdrawal of consent, the duration of treatment reaches 24 months, or any other reason that requires discontinuation of the study treatment, whichever occurs first.

Study Details

This is a Phase 2, open-label, multicenter study designed to evaluate the efficacy, safety and tolerability of IBI363 (study drug) in subjects with advanced, refractory solid malignancies.

Key Dates

Start date
Apr 8, 2024
Status verified
Dec 2024
Primary completion
Mar 1, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
178 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: IBI363
    IBI363 will be administered as an intravenous (IV) infusion every 2 weeks or every 3 weeks.

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: up to 2 years ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
University of California, San Francisco (UCSF)San FranciscoCalifornia94143
Katy Tsai, MD
[email protected]
415-353-9900
Michael Wong
[email protected]
415-502-5483
Katy Tsai, MD
Ocala Oncology CenterOcalaFlorida34474
Ketan Doshi, MD
[email protected]
352-547-1958
Sanjit Nirmalanandhan, Ph.D.
[email protected]
352-547-1958
Ketan Doshi, MD
BRCR Medical CenterPlantationFlorida33322
Chintan Gandhi, MD
[email protected]
561-447-0614
Diana Casaa
[email protected]
561-447-0614
Chintan Gandhi, MD
University of Kansas Medical Center (KUMC)FairwayKansas66205
Saqib Abbasi, MD
[email protected]
913-945-7545
Laura Mitchell
[email protected]
(913) 574-2854
Saqib Abbasi, MD
Michigan Hematology & Oncology Consultants - MedOnc DearbornDearbornMichigan48126
Faisal Musa, MD
[email protected]
313-514-4200
Heather Austin
[email protected]
585-216-7617
Faisal Musa, MD
Michigan Hematology & Oncology Consultants - MedOnc TroyTroyMichigan48098
Laura Nadeau, MD
[email protected]
206-667-4763
Heather Austin
[email protected]
585-216-7617
Laura Nadeau, MD
MD Anderson Cancer Center-University of TexasHoustonTexas77025
Sarina Piha-Paul, MD
[email protected]
713-563-1055
Qian Peng
[email protected]
713- 416-9928
Sarina Piha-Paul, MD
Oncology Consultants P.A.HoustonTexas77030
Mahran Shoukier
[email protected]
1-713-600-0913
Bryand Osorio
[email protected]
1-713-600-0913
Fred Hutchinson Cancer CenterSeattleWashington98109
Diane Tseng, MD
[email protected]
206-606-2936
Margaret Busey
[email protected]
206-667-2388
Diane Tseng, MD

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