MelanomaPhase 2NCT06081920
A Study of IBI363 in Subjects With Advanced Melanoma
A Phase 2 study testing IBI363 in people with Melanoma, run by Innovent Biologics (Suzhou) Co. Ltd. at 12 sites in China.
Trial summary
This is an open-lable, multicenter Phase II study to evaluate the safety, tolerability, and efficacy of IBI363 in advanced melanoma patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- IBI363
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 12 sitesChina
- Study dates
- 19 Oct 2023to 19 Oct 2028
- 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
- Histologically and/or cytologically confirmed, unresectable, locally advanced or metastatic melanoma (according to the American Joint Committee on Cancer (AJCC) 8th edition staging III-IV). Progression or recurrence after at least first-line systemic standard treatment.
- At least one measurable lesion (target lesion) per RECIST v1.1.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
- Life expectancy of 3 months or more.
- 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.
Who cannot join
- Pregnant or lactating subjects, or subjects who plan to conceive before, during, or within 6 months after the last dose of the study drug.
- Active or symptomatic central nervous system metastasis.
- At baseline (within 7 days before the first administration of the study drug), there were any hematological abnormalities as follows: hemoglobin<90 g/L; Absolute neutrophil count (ANC)<1.5 × 109/L; Platelet count<100 × 109/L.
- At baseline (within 7 days prior to first administration), there were any serum biochemical abnormalities as follows: Total bilirubin>1.5 × ULN; AST or ALT>3 × ULN; If it is tumor liver metastasis, AST or ALT>5.0 × ULN; Serum creatinine>1.5 × ULN or CCr<45 mL/min, using the Cockcroft Fault formula to calculate CCr (using actual body weight); Albumin<30 g/L.
- At baseline (within 7 days before first administration), there were any coagulation parameter abnormalities as follows: INR>1.5 × ULN (>3 if receiving anticoagulant therapy with stabilizer dosage) × ULN); PTT (or activated partial thromboplastin time (aPTT))>1.5 × ULN (>3 if receiving anticoagulant therapy with stabilizer dosage) × ULN).
- History of active thrombosis, deep vein thrombosis, or pulmonary embolism within 4 weeks prior to the first administration of the investigational drug, unless sufficient treatment has been given and the investigator believes that the condition is stable.
- Uncontrolled bleeding or known tendency to bleed.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
China12 sites, 12 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Jun Guo, 13911233048, guoj307@126.com
- Recruiting
Peking University Cancer Hospital & Institute, Beijing, China,
Beijing, Beijing Municipality, 100142
Jun Guo, 13911233048, guoj307@126.com
- Recruiting
Jilin Cancer Hospital
Changchun, Jilin, 130012
Xueying Zhang, 13304329877, 554597526@qq.com
- Recruiting
The first hospital of Jilin University
Changchun, Jilin, 130021
Di Wu, 13944888991, wudi888991@163.com
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410031
Xianan Li, 18874933879, lixianan2001@163.com;puxingxiang@hnca.org.cn
Xingxiang Pu, 15874180022
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350000
Yu Chen, 18950395132, chenyu1980@fjmu.edu.cn
- Recruiting
Qilu Hospital of Shandong university
Jinan, Shandong, 250012
Cuihua Yi, 18560082871, yicuihua@sdu.edu.cn
- Recruiting
Yunan Cancer Hospital
Kunming, Yunan, 650118
Ke Li, 13888052830, likelikelike@162.com
- Recruiting
The first affiliated hospital of Nanchang university
Nanchang, Jiangxi, 330052
Ling Zhang, 13672215566, zhang_l202@163.com
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210000
Zhengyun Zou, 13815891858, Zouzhengyun001@163.com
- Recruiting
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032
Huijing Feng, 15834121235, doctorfh@sina.com
- Recruiting
The Third people's hospital of Zhengzhou
Zhengzhou, Henan, 450044
Xianbin Liang, 15038212930, Wslxb666@126.com
About this study
Official title: A Phase II Study to Evaluate the Safety, Tolerability, and Efficacy of IBI363 in Subjects With Advanced Melanoma
This is an open-lable, multicenter Phase II study to evaluate the safety, tolerability, and efficacy of IBI363 in advanced melanoma patients
- Conditions
- Melanoma
- Being tested
- IBI363
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI363Biological
IBI363 monotherapy
| Study group | Role | What they receive |
|---|---|---|
| IBI363 | Experimental | Not described Receives: Biological: IBI363 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE（Adverse event）
Measured: 2 years
ORR（Objective response rate）
Measured: 2 years
DoR（duration of response）
Measured: 2 years
PFS (progression free survival)
Measured: 2 years
DCR (disease control rate)
Measured: 2 years
TTR (time to response)
Measured: 2 years
TTP (time to progression)
Measured: 2 years
Secondary outcomes (4)
OS（overall survival）
Measured: 2 years
PK concentration: IBI363 serum concentration
Measured: 2 years
ADA (Anti-drug antibody)
Measured: 2 years
Nab (Neutralizing antibody)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start19 Oct 2023
- Primary completion19 Oct 2028 (estimated)
- Study completion19 Oct 2028 (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
- 180 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
- NCT06081920
- Sponsor's protocol ID
- CIBI363A201
- Status last verified
- Jul 2026
- First submitted
- 7 Oct 2023
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Evaluate the Safety, Tolerability, and Efficacy of IBI363 in Subjects With Advanced Melanoma
- ClinicalTrials.gov ID
- NCT06081920
- Acronym / sponsor ID
- CIBI363A201
- Conditions
- Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- 19 Oct 2028 (estimated)
- Study completion
- 19 Oct 2028 (estimated)
- First posted
- 13 Oct 2023 (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 an open-lable, multicenter Phase II study to evaluate the safety, tolerability, and efficacy of IBI363 in advanced melanoma patients
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 | Biological: IBI363 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically and/or cytologically confirmed, unresectable, locally advanced or metastatic melanoma (according to the American Joint Committee on Cancer (AJCC) 8th edition staging III-IV). Progression or recurrence after at least first-line systemic standard treatment.
- At least one measurable lesion (target lesion) per RECIST v1.1.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
- Life expectancy of 3 months or more.
- 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.
Key exclusion criteria (7 listed)
- Pregnant or lactating subjects, or subjects who plan to conceive before, during, or within 6 months after the last dose of the study drug.
- Active or symptomatic central nervous system metastasis.
- At baseline (within 7 days before the first administration of the study drug), there were any hematological abnormalities as follows: hemoglobin<90 g/L; Absolute neutrophil count (ANC)<1.5 × 109/L; Platelet count<100 × 109/L.
- At baseline (within 7 days prior to first administration), there were any serum biochemical abnormalities as follows: Total bilirubin>1.5 × ULN; AST or ALT>3 × ULN; If it is tumor liver metastasis, AST or ALT>5.0 × ULN; Serum creatinine>1.5 × ULN or CCr<45 mL/min, using the Cockcroft Fault formula to calculate CCr (using actual body weight); Albumin<30 g/L.
- At baseline (within 7 days before first administration), there were any coagulation parameter abnormalities as follows: INR>1.5 × ULN (>3 if receiving anticoagulant therapy with stabilizer dosage) × ULN); PTT (or activated partial thromboplastin time (aPTT))>1.5 × ULN (>3 if receiving anticoagulant therapy with stabilizer dosage) × ULN).
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 monotherapy | Biological | IBI363 |
Primary outcome
AE（Adverse event）
Time frame: 2 years
ORR（Objective response rate）
Time frame: 2 years
DoR（duration of response）
Time frame: 2 years
PFS (progression free survival)
Time frame: 2 years
DCR (disease control rate)
Time frame: 2 years
TTR (time to response)
Time frame: 2 years
TTP (time to progression)
Time frame: 2 years
4 secondary outcomes
OS（overall survival）
Time frame: 2 years
PK concentration: IBI363 serum concentration
Time frame: 2 years
ADA (Anti-drug antibody)
Time frame: 2 years
Nab (Neutralizing antibody)
Time frame: 2 years
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 29 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Melanoma
Enrolling by invitationObservational study
Community Based Strategies for Early Detection of Melanoma
Melanoma
Active, not recruitingPhase 3
Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8
Active, not recruitingPhase 2
A Study to Compare the Administration of Pembrolizumab After Surgery Versus Administration Both Before and After Surgery for High-Risk Melanoma
Acral Lentiginous Melanoma, Clinical Stage III Cutaneous Melanoma AJCC v8
RecruitingObservational study
Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Melanoma
Melanoma, Dysplastic Nevus Syndrome
RecruitingPhase 1
A Phase 1 Study to Evaluate OPB-201 in Recurrent Endometrial and Platinum-resistant Ovarian Cancer.
Endometrial Cancer Recurrent, Endometrial Cancer
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.
12 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, run by Innovent Biologics (Suzhou) Co. Ltd. at 12 sites in China.
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 5 inclusion and 7 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 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. 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 Haiyun Zuo (0512-69566088, haiyun.zuo@innoventbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AE（Adverse event） (time frame: 2 years). The study lists 7 primary outcomes in all. 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 29 Jul 2026.