Advanced Solid TumorPhase 1NCT04162327
A Phase Ia/Ib Study of IBI315 in Patients With HER2-expressing Advanced Solid Tumor
A Phase 1 study testing IBI315 in people with Advanced Solid Tumor, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
The primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (RP2D) of IBI315, a HER2/PD-1 bi-specific antibody in patients 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 Tumor
- What is being tested?
- IBI315
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- 26 Nov 2019to 20 Jun 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
- Written (signed) informed consent.
- Life expectancy ≥12 weeks.
- Patients with HER2-expressing advanced solid tumor who failed on current standard of care
- According to RECIST 1.1, at least one measurable lesion (radiation-naïve) exists.
- ECOG performance status 0-1.
- Adequate organ and marrow function evaluated by laboratory tests as follow:
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- CBC: absolute neutrophil count (ANC) ≥ 1.0×109/L (Ia stage) or 1.5×109/L (Ib stage); Platelet (PLT) ≥ 75×109/L; Hemoglobin (HGB) ≥ 9.0g/L;
- Liver function: Total bilirubin (TBIL) ≤ 1.5×upper limit of normal value (ULN) for patients without hepatic metastases, ≤ 2×ULN for patients with hepatic metastases or Gilbert syndrome; Alanine aminotransferase (ALT) ≤ 2.5×ULN; Aspartate transferase (AST) ≤ 2.5×ULN;
- Renal function: Clearance of creatinine (CCr) by Cockcroft-Gault formula or 24-hour urine collection ≥ 50ml/min;
- Urinalysis: urine protein < 2+ or urine protein in 24-hour urine collection < 1g;
- Coagulation function: activated partial thromboplastin time (APTT）≤ 1.5×ULN; international normalized ratio (INR）≤ 1.5
- left ventricular ejection fraction (LVEF) ≥ 50% by echocardiography;
- Accumulative exposure to doxorubicin ≤ 360mg/m2; accumulative exposure to epirubicin ≤ 720mg/m2;
- Agree to use an approved contraceptive method during the treatment period, until 180 days after last dose of treatment.
- Post-menopause female subject or pre-menopause female with negative HCG level in urine or blood.
Who cannot join
- Any greater than NCI CTCAE 0/1 adverse event exists within 4 weeks before enrollment, not including hair loss and fatigue;
- Received major surgery or having unhealed wound, ulcer, or bone fracture;• Received whole pelvic radiation;
- Plan to receive any other anti-cancer therapy not specified in the protocol, except for palliative radiotherapy;
- CNS metastasis, spinal compression, or carcinomatous meningitis
- Active autoimmune disease or inflammatory disorders.
- Primary immunodeficiency diseases;
- Pregnant or breast-feeding female.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ia/Ib, Open-label, Multicenter, Dose-escalation Study Evaluating the Safety, Tolerability, and Potential Efficacy of IBI315, an Anti-HER2/PD-1 Bi-specific Antibody in Patients With HER2-expressing Advanced Solid Tumor
The primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (RP2D) of IBI315, a HER2/PD-1 bi-specific antibody in patients with advanced solid tumors
Read the detailed description
This phase Ia/Ib, open-label, multicenter study has two stages. The Ia stage is a dose-escalation study that will focus on safety, tolerability, efficacy and RP2D . Patients with HER2-expressing advanced solid tumor who failed from previous standard of care will be enrolled in the phase Ia study. DLT observation period is 28 days.
- Conditions
- Advanced Solid Tumor
- Being tested
- IBI315
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI315Drug
Patients will receive IBI315 until disease progression, intolerability, informed consent withdraw, or other reasons leading to treatment discontinue.
IBI315Drug
Patients will receive IBI315 RP2D until disease progression,intolerability, informed consent withdraw, or otherreasons leading to treatment discontinue.
| Study group | Role | What they receive |
|---|---|---|
| Ia stage - IBI315 Dose escalation | Experimental | Not described Receives: Drug: IBI315 |
| Ib stage - IBI315 monotherapy | Experimental | Not described Receives: Drug: IBI315 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve (AUC)
Measured: up to 9 months
Maximum plasma concentration (Cmax)
Measured: up to 9 months
Terminal elimination half-life (T1/2)
Measured: up to 9 months
Apparent volume of distribution (Vd)
Measured: up to 9 months
Secondary outcomes (3)
Evaluate receptor occupancy (RO) following single-dose or multi-dose of IBI315
Measured: up to 9 months
The percentage of participants with anti-drug antibody (ADA) positive after dosing IBI315
Measured: up to 9 months
The percentage of participants with neutralizing antibody (NAb) positive after dosing IBI315
Measured: up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start26 Nov 2019
- Primary completion27 Jan 2022
- Study completion20 Jun 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
- 55 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
- NCT04162327
- Sponsor's protocol ID
- CIBI315A101
- Status last verified
- Oct 2023
- First submitted
- 31 Oct 2019
- Last updated
- 24 Oct 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 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia/Ib, Open-label, Multicenter, Dose-escalation Study Evaluating the Safety, Tolerability, and Potential Efficacy of IBI315, an Anti-HER2/PD-1 Bi-specific Antibody in Patients With HER2-expressing Advanced Solid Tumor
- ClinicalTrials.gov ID
- NCT04162327
- Acronym / sponsor ID
- CIBI315A101
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Nov 2019 (actual)
- Primary completion
- 27 Jan 2022 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 14 Nov 2019 (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.
The primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (RP2D) of IBI315, a HER2/PD-1 bi-specific antibody in patients with advanced solid tumors
Detailed description
This phase Ia/Ib, open-label, multicenter study has two stages. The Ia stage is a dose-escalation study that will focus on safety, tolerability, efficacy and RP2D . Patients with HER2-expressing advanced solid tumor who failed from previous standard of care will be enrolled in the phase Ia study. DLT observation period is 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ia stage - IBI315 Dose escalation | Experimental | Drug: IBI315 |
| Ib stage - IBI315 monotherapy | Experimental | Drug: IBI315 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Written (signed) informed consent.
- Life expectancy ≥12 weeks.
- Patients with HER2-expressing advanced solid tumor who failed on current standard of care
- According to RECIST 1.1, at least one measurable lesion (radiation-naïve) exists.
- ECOG performance status 0-1.
Key exclusion criteria (7 listed)
- Any greater than NCI CTCAE 0/1 adverse event exists within 4 weeks before enrollment, not including hair loss and fatigue;
- Received major surgery or having unhealed wound, ulcer, or bone fracture;• Received whole pelvic radiation;
- Plan to receive any other anti-cancer therapy not specified in the protocol, except for palliative radiotherapy;
- CNS metastasis, spinal compression, or carcinomatous meningitis
- Active autoimmune disease or inflammatory disorders.
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 |
|---|---|---|
| IBI315Patients will receive IBI315 until disease progression, intolerability, informed consent withdraw, or other reasons leading to treatment discontinue. | Drug | Ia stage - IBI315 Dose escalation |
| IBI315Patients will receive IBI315 RP2D until disease progression,intolerability, informed consent withdraw, or otherreasons leading to treatment discontinue. | Drug | Ib stage - IBI315 monotherapy |
Primary outcome
Area under the plasma concentration-time curve (AUC)
Time frame: up to 9 months
Maximum plasma concentration (Cmax)
Time frame: up to 9 months
Terminal elimination half-life (T1/2)
Time frame: up to 9 months
Apparent volume of distribution (Vd)
Time frame: up to 9 months
3 secondary outcomes
Evaluate receptor occupancy (RO) following single-dose or multi-dose of IBI315
Time frame: up to 9 months
The percentage of participants with anti-drug antibody (ADA) positive after dosing IBI315
Time frame: up to 9 months
The percentage of participants with neutralizing antibody (NAb) positive after dosing IBI315
Time frame: up to 9 months
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 24 Oct 2023.
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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.
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 IBI315 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 15 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: finished, as of the sponsor's last update on 24 Oct 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?
Area under the plasma concentration-time curve (AUC) (time frame: up to 9 months). The study lists 4 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 24 Oct 2023.