Advanced Solid TumorsPhase 1NCT05172856
A Phase Ib Study of Primary Efficacy and Safety of IBI321 Monotherapy or Combination Therapy in Patients With Advanced Solid Tumors
A Phase 1 study testing IBI321 in people with Advanced Solid Tumors, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
This is open-label, multicenter, Phase Ib study is designed to evaluate the Primary Efficacy and Safety of IBI321 Monotherapy or Combination Therapy in participants with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- IBI321
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 31 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures.
- Male or female subjects ≥18 years and ≤75 years.
- At least one measurable lesion per RECIST version 1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1
- Life expectancy of ≥ 12 weeks.
- Adequate hematologic and end organ function
Who cannot join
- Failure to recover from adverse events from the most recent anti-tumor treatments
- Acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
- 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.
- Any other serious underlying medical (e.g., uncontrolled hypertension, active uncontrolled infection, active gastric ulcer,uncontrolled seizures, cerebrovascular incidents, gastrointestinal bleeding, severe signs and symptoms of coagulation and clotting disorders, other serious cardiac conditions not listed in exclusion criteria), psychiatric, psychological, familial or geographical condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.
- Pregnancy, lactation, breastfeeding.
- Previous exposure to any anti-TIGIT antibody, or recombinant protein.
Trial locations and contacts
1 site in 1 country.
China1 site
Hunan Cancer Hospital
Changsha, Hunan, 410013
Lin Wu, 13170419973, wulin-calf@vip.163.com
About this study
Official title: A Phase Ib, Open-Label, Multi-Center, Study of Primary Efficacy and Safety of IBI321 Monotherapy or Combination Therapy in Patients With Advanced Solid Tumors
This is open-label, multicenter, Phase Ib study is designed to evaluate the Primary Efficacy and Safety of IBI321 Monotherapy or Combination Therapy in participants with advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- IBI321
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI321Drug
IBI321 at a dose no higher than RP2D, D1 IV Q3W.
| Study group | Role | What they receive |
|---|---|---|
| IBI321 in advanced solid tumors | Experimental | Not described Receives: Drug: IBI321 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators.
Measured: From Baseline until disease progression (up to 2 years)
Secondary outcomes (9)
Progression Free Survival (PFS), According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators.
Measured: From Baseline until disease progression (up to 2 years)
Overall Survival (OS)
Measured: From Day 1 to up to 2 years
Percentage of Participants with Adverse Events (AEs) per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0
Measured: From Day 1 to up to 2 years
Area Under the Concentration-Time Curve (AUC) of IBI321
Measured: From Day 1 up to 2 years
Maximum Serum Concentration (Cmax) of IBI321
Measured: From Day 1 up to 2 years
Minimum Serum Concentration (Cmin) of IBI321
Measured: From Day 1 up to 2 years
Clearance (CL) of IBI321
Measured: From Day 1 up to 2 years
Percentage of Participants with Anti-Drug Antibodies (ADAs) to IBI321
Measured: From Day 1 up to 2 years
Percentage of Participants with Neutralizing Antibody (Nab) to IBI321
Measured: From Day 1 up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start1 Mar 2022 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 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
- NCT05172856
- Sponsor's protocol ID
- CIBI321A103
- Status last verified
- Dec 2021
- First submitted
- 23 Dec 2021
- Last updated
- 29 Dec 2021
- 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 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Open-Label, Multi-Center, Study of Primary Efficacy and Safety of IBI321 Monotherapy or Combination Therapy in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05172856
- Acronym / sponsor ID
- CIBI321A103
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 29 Dec 2021 (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 open-label, multicenter, Phase Ib study is designed to evaluate the Primary Efficacy and Safety of IBI321 Monotherapy or Combination Therapy in participants with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBI321 in advanced solid tumors | Experimental | Drug: IBI321 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures.
- Male or female subjects ≥18 years and ≤75 years.
- At least one measurable lesion per RECIST version 1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1
- Life expectancy of ≥ 12 weeks.
Key exclusion criteria (6 listed)
- Failure to recover from adverse events from the most recent anti-tumor treatments
- Acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
- 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.
- Any other serious underlying medical (e.g., uncontrolled hypertension, active uncontrolled infection, active gastric ulcer,uncontrolled seizures, cerebrovascular incidents, gastrointestinal bleeding, severe signs and symptoms of coagulation and clotting disorders, other serious cardiac conditions not listed in exclusion criteria), psychiatric, psychological, familial or geographical condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.
- Pregnancy, lactation, breastfeeding.
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 |
|---|---|---|
| IBI321IBI321 at a dose no higher than RP2D, D1 IV Q3W. | Drug | IBI321 in advanced solid tumors |
Primary outcome
Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators.
Time frame: From Baseline until disease progression (up to 2 years)
9 secondary outcomes
Progression Free Survival (PFS), According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators.
Time frame: From Baseline until disease progression (up to 2 years)
Overall Survival (OS)
Time frame: From Day 1 to up to 2 years
Percentage of Participants with Adverse Events (AEs) per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0
Time frame: From Day 1 to up to 2 years
Area Under the Concentration-Time Curve (AUC) of IBI321
Time frame: From Day 1 up to 2 years
Maximum Serum Concentration (Cmax) of IBI321
Time frame: From Day 1 up to 2 years
Minimum Serum Concentration (Cmin) of IBI321
Time frame: From Day 1 up to 2 years
Clearance (CL) of IBI321
Time frame: From Day 1 up to 2 years
Percentage of Participants with Anti-Drug Antibodies (ADAs) to IBI321
Time frame: From Day 1 up to 2 years
Percentage of Participants with Neutralizing Antibody (Nab) to IBI321
Time frame: From Day 1 up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IBI321 in people with Advanced Solid Tumors, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 29 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Wu (18117822381, yang.wu@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) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators. (time frame: From Baseline until disease progression (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 29 Dec 2021.