Advanced Solid TumorsPhase 1NCT04911894
A Study of Dose Escalation of IBI321 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 first-in-human open-label, multicenter, dose-escalation and expansion study is designed to evaluate the safety, tolerability, and primary efficacy of IBI321 in participants with locally advanced, recurrent, or metastatic incurable tumors for whom standard therapy does not exist, has proven to be ineffective or… 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
- 16 participants
- Where
- 1 siteChina
- Study dates
- 21 Jun 2021to 17 Feb 2023
- 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.
- Patients with advanced solid tumors who had failed standard treatment.
- 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
- Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, targeted therapy, or immunotherapy.
- Failure to recover from adverse events from the most recent anti-tumor
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ia/Ib, Open-Label, Multi-Center, Study of the Safety, Tolerability and Primary Efficacy of IBI321 in Patients With Advanced Solid Tumors
This first-in-human open-label, multicenter, dose-escalation and expansion study is designed to evaluate the safety, tolerability, and primary efficacy of IBI321 in participants with locally advanced, recurrent, or metastatic incurable tumors for whom standard therapy does not exist, has proven to be ineffective or intolerable.
- 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
Several dose levels will be evaluated for IBI321 administered as a single agent. IBI321 will be given via IV infusion on Day 1 of each cycle until disease progression or loss of clinical benefit.
| Study group | Role | What they receive |
|---|---|---|
| Phase Ia Dose-Escalation Stage: IBI321 | Experimental | Not described Receives: Drug: IBI321 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Dose-Limiting Toxicities (DLTs)
Measured: From Day 1 of Cycle 1 to Day 28
Percentage of Participants with Adverse Events (AEs), treatment-related AE (TRAE), immune-related AEs (irAE) and serious adverse event (SAE) per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0
Measured: From Day 1 to up to 2 years
Secondary outcomes (9)
Objective Response Rate (ORR)per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Measured: From Baseline until disease progression (up to 2 years)
Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Measured: From Baseline until disease progression (up to 2 years)
Duration of Response (DoR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Measured: From Baseline until disease progression (up to 2 years)
Overall Survival (OS)
Measured: From Baseline until disease progression (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) and 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 posted3 Jun 2021
- Study start21 Jun 2021
- Primary completion30 Jan 2023
- Study completion17 Feb 2023
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
- Sequential
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
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
- NCT04911894
- Sponsor's protocol ID
- CIBI321A102
- Status last verified
- Feb 2023
- First submitted
- 25 May 2021
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia/Ib, Open-Label, Multi-Center, Study of the Safety, Tolerability and Primary Efficacy of IBI321 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04911894
- Acronym / sponsor ID
- CIBI321A102
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 17 Feb 2023 (actual)
- First posted
- 3 Jun 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 first-in-human open-label, multicenter, dose-escalation and expansion study is designed to evaluate the safety, tolerability, and primary efficacy of IBI321 in participants with locally advanced, recurrent, or metastatic incurable tumors for whom standard therapy does not exist, has proven to be ineffective or intolerable.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase Ia Dose-Escalation Stage: IBI321 | 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 (7 listed)
- Subjects able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures.
- Patients with advanced solid tumors who had failed standard treatment.
- 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
Key exclusion criteria (6 listed)
- Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, targeted therapy, or immunotherapy.
- Failure to recover from adverse events from the most recent anti-tumor
- 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.
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 |
|---|---|---|
| IBI321Several dose levels will be evaluated for IBI321 administered as a single agent. IBI321 will be given via IV infusion on Day 1 of each cycle until disease progression or loss of clinical benefit. | Drug | Phase Ia Dose-Escalation Stage: IBI321 |
Primary outcome
Percentage of Participants with Dose-Limiting Toxicities (DLTs)
Time frame: From Day 1 of Cycle 1 to Day 28
Percentage of Participants with Adverse Events (AEs), treatment-related AE (TRAE), immune-related AEs (irAE) and serious adverse event (SAE) 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
9 secondary outcomes
Objective Response Rate (ORR)per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Time frame: From Baseline until disease progression (up to 2 years)
Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Time frame: From Baseline until disease progression (up to 2 years)
Duration of Response (DoR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Time frame: From Baseline until disease progression (up to 2 years)
Overall Survival (OS)
Time frame: From Baseline until disease progression (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) and Neutralizing Antibody (Nab) to IBI321
Time frame: From Day 1 up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
Related trials for Advanced Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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.
The record lists no contact. Use the official record to reach the sponsor.
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 7 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: finished, as of the sponsor's last update on 1 Mar 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with Dose-Limiting Toxicities (DLTs) (time frame: From Day 1 of Cycle 1 to Day 28). The study lists 2 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 1 Mar 2023; AzTrials last refreshed its copy on 7 Nov 2026.