MelanomaPhase 2NCT06281678
A Study of IBI363 in Subjects with Advanced Solid Malignancies
A Phase 2 study testing IBI363 in people with Melanoma and Non-small Cell Lung Cancer, run by Innovent Biologics (Suzhou) Co. Ltd. at 9 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Non-small Cell Lung Cancer, Colorectal Cancer
- What is being tested?
- IBI363
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 9 sitesUnited States
- Study dates
- 8 Apr 2024to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects have the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;
- Male or female subjects ≥ 18 years old;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
- Anticipated life expectancy of ≥ 3 months;
Who cannot join
- Inadequate bone marrow and organ function;
- Received previous anti-tumor therapy: Any chemotherapy or targeted small molecule therapy (standard or investigational) within 2 weeks or 5 plasma half-lives. Received Nitrosoureas and mitomycin C within 6 weeks prior to first dose of study drug and during study; Any anti-cancer monoclonal antibody (mAb) within 4 weeks prior to first dose
- Received live vaccines within 28 days prior to first administration of the study drug or plan on receiving any live vaccine during the study;
- Has adverse reactions resulting from previous antitumor therapies, which have not resolved to Grade 0 or 1 toxicity according to NCI-CTCAE v5.0 (except for alopecia, fatigue, pigmentation and other conditions with no safety risk according to investigator' discretion) or baseline prior to the first dose of the study drug;
- Undergone major surgery (Craniotomy, thoracotomy or laparotomy, and other surgery according to investigator' discretion, excluding needle biopsy) within 4 weeks prior to the first dose of the study drug, or who are expected to undergo major surgery during the study period, or who have severe unhealed wounds, trauma, ulcers, etc.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
Michigan Hematology & Oncology Consultants - MedOnc Dearborn
Dearborn, Michigan, 48126
Faisal Musa, MD, 313-514-4200, Fmusa@mhpdoctor.com
Heather Austin, 585-216-7617, heather.austin@profoundresearch.io
- Recruiting
University of Kansas Medical Center (KUMC)
Fairway, Kansas, 66205
Saqib Abbasi, MD, 913-945-7545, sabbasi@kumc.edu
Laura Mitchell, (913) 574-2854, lmitchell11@kumc.edu
- Recruiting
MD Anderson Cancer Center-University of Texas
Houston, Texas, 77025
Sarina Piha-Paul, MD, 713-563-1055, spihapau@mdanderson.org
Qian Peng, 713- 416-9928, qpeng@mdanderson.org
- Recruiting
Oncology Consultants P.A.
Houston, Texas, 77030
Mahran Shoukier, 1-713-600-0913, mshoukier@oncologyconsu.com
Bryand Osorio, 1-713-600-0913 ext. 1008, bosorio@oncologyconsultants.com
- Recruiting
Ocala Oncology Center
Ocala, Florida, 34474
Ketan Doshi, MD, 352-547-1958, Ketan.Doshi@USONCOLOGY.COM
Sanjit Nirmalanandhan, Ph.D., 352-547-1958, Sanjit.Nirmalanandhan@usoncology.com
- Recruiting
BRCR Medical Center
Plantation, Florida, 33322
Chintan Gandhi, MD, 561-447-0614, Cghandhi.md@brcrglobal.com
Diana Casaa, 561-447-0614 ext. 142, dianac@brcrglobal.com
- Recruiting
University of California, San Francisco (UCSF)
San Francisco, California, 94143
Katy Tsai, MD, 415-353-9900, Katy.Tsai@ucsf.edu
Michael Wong, 415-502-5483, Michael.Wong2@ucsf.edu
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Diane Tseng, MD, 206-606-2936, ditseng@uw.edu
Margaret Busey, 206-667-2388, mbusey2@fredhutch.org
- Recruiting
Michigan Hematology & Oncology Consultants - MedOnc Troy
Troy, Michigan, 48098
Laura Nadeau, MD, 206-667-4763, lnadeau@mhpdoctor.com
Heather Austin, 585-216-7617, heather.austin@profoundresearch.io
About this study
Official title: A Phase 2, Open-label, Multicenter Study of IBI363 (PD1-IL2m) in Subjects with Advanced Solid Malignancies
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.
- Being tested
- IBI363
- Medical subject headings
- Melanoma, Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI363Drug
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 group | Role | What they receive |
|---|---|---|
| IBI363 | Experimental | IBI363 will be administered as an intravenous (IV) infusion every 2 weeks or every 3 weeks. Receives: Drug: IBI363 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Measured: up to 2 years
Secondary outcomes (2)
Adverse Event （AE）
Measured: Up to 90 days post last dose
Dose-limiting Toxicity （DLT）
Measured: The DLT observation period is 35 days starting from the first day of cycle 1 (C1D1) for subjects assigned to 1000 μg/kg Q2W, while 28 days starting from the C1D1 for subjects assigned to 2000/3000/4000 μg/kg Q3W.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start8 Apr 2024
- Primary completion1 Mar 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281678
- Sponsor's protocol ID
- CIBI363A202
- Status last verified
- Dec 2024
- First submitted
- 4 Feb 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-label, Multicenter Study of IBI363 (PD1-IL2m) in Subjects with Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT06281678
- Acronym / sponsor ID
- CIBI363A202
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBI363 | Experimental | Drug: IBI363IBI363 will be administered as an intravenous (IV) infusion every 2 weeks or every 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects have the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;
- Male or female subjects ≥ 18 years old;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
- Anticipated life expectancy of ≥ 3 months;
Key exclusion criteria (5 listed)
- Inadequate bone marrow and organ function;
- Received previous anti-tumor therapy: Any chemotherapy or targeted small molecule therapy (standard or investigational) within 2 weeks or 5 plasma half-lives. Received Nitrosoureas and mitomycin C within 6 weeks prior to first dose of study drug and during study; Any anti-cancer monoclonal antibody (mAb) within 4 weeks prior to first dose
- Received live vaccines within 28 days prior to first administration of the study drug or plan on receiving any live vaccine during the study;
- Has adverse reactions resulting from previous antitumor therapies, which have not resolved to Grade 0 or 1 toxicity according to NCI-CTCAE v5.0 (except for alopecia, fatigue, pigmentation and other conditions with no safety risk according to investigator' discretion) or baseline prior to the first dose of the study drug;
- Undergone major surgery (Craniotomy, thoracotomy or laparotomy, and other surgery according to investigator' discretion, excluding needle biopsy) within 4 weeks prior to the first dose of the study drug, or who are expected to undergo major surgery during the study period, or who have severe unhealed wounds, trauma, ulcers, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IBI363IBI363 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. | Drug | IBI363 |
Primary outcome
Objective response rate (ORR)
Time frame: up to 2 years
2 secondary outcomes
Adverse Event （AE）
Time frame: Up to 90 days post last dose
Dose-limiting Toxicity （DLT）
Time frame: The DLT observation period is 35 days starting from the first day of cycle 1 (C1D1) for subjects assigned to 1000 μg/kg Q2W, while 28 days starting from the C1D1 for subjects assigned to 2000/3000/4000 μg/kg Q3W.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IBI363 in people with Melanoma and Non-small Cell Lung Cancer, run by Innovent Biologics (Suzhou) Co. Ltd. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amanda Guo (1-832-207-5244, amanda.guo@innoventbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024.