Advanced Solid TumorPhase 1NCT05043298

A Phase Ia/Ib Clinical Trial of IBI360 Monotherapy or in Combination With Sintilimab and (or) Chemotherapy in Advanced or Metastatic Solid Tumors

A Phase 1 study testing IBI 360 Injection and IBI 360 Injection Sintilimab in people with Advanced Solid Tumor, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is an open label Phase Ia/Ib trial to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of IBI360 monotherapy in Advanced or Metastatic Solid Tumors Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Advanced Solid Tumor
What is being tested?: IBI 360 Injection and IBI 360 Injection Sintilimab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteChina
Study dates: 27 Oct 2021to 30 Aug 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

Provide signed informed consent;
Male or female aged at 18-75 (inclusive) years;
Expected survival ≥12 weeks;
ECOG PS score 0 or 1;
Provide archival or fresh tissues for CLDN18.2 expression analysis;
Adequate laboratory parameters;

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Suffer from advanced or metastatic malignant local solid tumors confirmed by histological diagnosis and meet the criteria of the enrolled group as follows:
Ia: The subjects for whom no standard treatment regimens are available or who is intolerable to standard treatments.
Ib: pancreatic carcinoma, HER2 negative gastric adenocarcinoma, advanced or metastatic solid tumors

Who cannot join

The subjects who received the treatment with CLDN18.2 monoclonal antibody or CLDN-18.2 CART;
The subjects who received other anti-tumor medication within 4 weeks prior to the initial dose of the study drug;
Any toxicity due to previous anti-tumor therapy that has not yet resolved to NCI CTCAE v5.0 grade 0 or 1 prior to the first dose of study treatment;
The subjects with history of hypersensitivity to the study drug;
The subjects were not recovery after surgery with history of gastrointestinal perforation or fistula within 6 months prior to the enrollment;
The subjects with symptomatic central nervous system (CNS) metastasis or carcinomatous meningitis;
The subjects with pyloric obstruction;
The subjects with active or poorly controlled serious infections

Trial locations and contacts

1 site in 1 country.

China1 site

Innovent Biologics (suzhou) Co. , Ltd.
Suzhou, Jiangsu, 215000

Other trials in China

About this study

Official title: A Phase Ia/Ib Open-Label, Multi-Center Clinical Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of IBI360 Monotherapy or in Combination With Sintilimab and (or) Chemotherapy in Advanced or Metastatic Solid Tumors

This is an open label Phase Ia/Ib trial to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of IBI360 monotherapy in Advanced or Metastatic Solid Tumors

Read the detailed description

Phase Ia is dose escalation and dose expansion study of IBI360 monotherapy and IBI360 in combination with sintilimab in advanced or metastatic Solid Tumors; Phase Ib is an multi-cohort trial of pancreatic carcinoma, HER2 negative gastric adenocarcinoma, advanced or metastatic solid tumors to evaluate safety and preliminary efSficacy of IBI360 in combination with sintilimab and (or) chemotherapy or IBI360 monotherapy.

Conditions: Advanced Solid Tumor
Being tested: IBI 360 Injection, IBI 360 Injection Sintilimab
Keywords: Advanced Solid Tumor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IBI 360 InjectionDrug
IBI 360 dose level of escalation IV Q3W Day 1
IBI 360 Injection SintilimabDrug
IBI 360 dose level of escalation IV Q3W Day 1 Sintilimab 200mg IV Q3W Day 1

Study groups in NCT05043298
Study group	Role	What they receive
IBI360	Experimental	Not described Receives: Drug: IBI 360 Injection
IBI 360 + Sintilimab	Experimental	Not described Receives: Drug: IBI 360 Injection Sintilimab

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and tolerance
Participant safety is characterized by frequency and severity of adverse events(according to NCI CTCAE 5.0)
Measured: up to 90 days following last dose
Recommended Phase 2 Dose (RP2D)
A recommended phase 2 dose will be determined based on safety data including dose limiting toxicities, preliminary efficacy data, and PK data
Measured: up to 21 days following last dose level

Secondary outcomes (7)

Efficacy
Tumor response will be determined by the revised Response Evaluation Criteria in Solid Tumors version 1.1 (RECISTv1.1).
Measured: Subjects were randomized 6 months and 1 year later
Pharmacokinetics
Area under plasma concentration vs time curve(AUC)
Measured: Up to 48 weeks following first dose
Immunogenicity
Incidence of anti-drug antibodies (ADA) will be measured
Measured: up to 90 days following last dose
Pharmacokinetics
Peak plasma concentration(Cmax)
Measured: Up to 48 weeks following first dose
Pharmacokinetics
Up to 48 weeks following first dose
Measured: Clearance（CL）
Pharmacokinetics
Apparent volumeof distribution（V）
Measured: Up to 48 weeks following first dose
Pharmacokinetics
Terminal Half Life（T1/2）
Measured: Up to 48 weeks following first dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Oct 202130 Aug 2023

First posted14 Sep 2021
Study start27 Oct 2021
Primary completion30 Aug 2023
Study completion30 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced Solid TumorStudies 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05043298
Sponsor's protocol ID: CIBI360A101
Status last verified: Oct 2024
First submitted: 5 Sep 2021
Last updated: 17 Oct 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Advanced Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase Ia/Ib Open-Label, Multi-Center Clinical Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of IBI360 Monotherapy or in Combination With Sintilimab and (or) Chemotherapy in Advanced or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT05043298
Acronym / sponsor ID: CIBI360A101
Conditions: Advanced Solid Tumor
Keywords: Advanced Solid Tumor
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
Study start: 27 Oct 2021 (actual)
Primary completion: 30 Aug 2023 (actual)
Study completion: 30 Aug 2023 (actual)
First posted: 14 Sep 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 an open label Phase Ia/Ib trial to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of IBI360 monotherapy in Advanced or Metastatic Solid Tumors

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
IBI360	Experimental	Drug: IBI 360 Injection
IBI 360 + Sintilimab	Experimental	Drug: IBI 360 Injection Sintilimab

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Provide signed informed consent;
Male or female aged at 18-75 (inclusive) years;
Expected survival ≥12 weeks;
ECOG PS score 0 or 1;
Provide archival or fresh tissues for CLDN18.2 expression analysis;

Key exclusion criteria (8 listed)

The subjects who received the treatment with CLDN18.2 monoclonal antibody or CLDN-18.2 CART;
The subjects who received other anti-tumor medication within 4 weeks prior to the initial dose of the study drug;
Any toxicity due to previous anti-tumor therapy that has not yet resolved to NCI CTCAE v5.0 grade 0 or 1 prior to the first dose of study treatment;
The subjects with history of hypersensitivity to the study drug;
The subjects were not recovery after surgery with history of gastrointestinal perforation or fistula within 6 months prior to the enrollment;

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
IBI 360 InjectionIBI 360 dose level of escalation IV Q3W Day 1	Drug	IBI360
IBI 360 Injection SintilimabIBI 360 dose level of escalation IV Q3W Day 1 Sintilimab 200mg IV Q3W Day 1	Drug	IBI 360 + Sintilimab

Primary outcome

Safety and tolerance
Time frame: up to 90 days following last dose
Participant safety is characterized by frequency and severity of adverse events(according to NCI CTCAE 5.0)
Recommended Phase 2 Dose (RP2D)
Time frame: up to 21 days following last dose level
A recommended phase 2 dose will be determined based on safety data including dose limiting toxicities, preliminary efficacy data, and PK data

7 secondary outcomes

Efficacy
Time frame: Subjects were randomized 6 months and 1 year later
Pharmacokinetics
Time frame: Up to 48 weeks following first dose
Immunogenicity
Time frame: up to 90 days following last dose
Pharmacokinetics
Time frame: Up to 48 weeks following first dose
Pharmacokinetics
Time frame: Clearance（CL）
Pharmacokinetics
Time frame: Up to 48 weeks following first dose
Pharmacokinetics
Time frame: Up to 48 weeks following first dose

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 17 Oct 2024.
Individual participant dataSharing planned: No

Related trials for Advanced Solid Tumor

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 IBI 360 Injection and IBI 360 Injection Sintilimab in people with Advanced Solid Tumor, 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 9 inclusion and 8 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 17 Oct 2024. 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?

Safety and tolerance (time frame: up to 90 days following last dose). 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?

On the ClinicalTrials.gov record for NCT05043298.

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 17 Oct 2024.